The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 — currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.

The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMate 3 prevented the device from sealing, causing multiple strokes and leading to a severe brain injury and multiorgan failure. Herrman “could not have anticipated the danger this defect … created for him,” the lawsuit said.

Herrman’s death was reported to a Food and Drug Administration database where the public can learn about device-related deaths, serious injuries, and malfunctions. The event was also described in the peer-reviewed Journal of Heart and Lung Transplantation.

In September 2021, Ramon Flores Sr. had the same device implanted at Methodist Hospital of San Antonio. A lawsuit his family filed in August alleges that the locking mechanism defect led to air embolism strokes. Flores died eight days after surgery, at age 76.

“How many other people is this going to happen to?” said his daughter, Alanna Flores Blanco, 52. “We never, ever were explained that the device could malfunction and this could happen.”

After the deaths of Herrman and Flores, Thoratec Corp., the device’s manufacturer, evaluated the pumps involved. In both cases, Thoratec, a subsidiary of Abbott Laboratories, confirmed a bent locking arm. But “a direct correlation” between the HeartMate 3 and the deaths “could not conclusively be established,” the manufacturer reported to the FDA.

Abbott did not respond to questions about the deaths or the alleged defects. The manufacturer denied liability in both cases. It settled Herrman’s lawsuit this fall, and the Flores case is ongoing.

The men’s deaths are among more than 4,500 reports since August 2017 in which the HeartMate 3 may have caused or contributed to a patient’s death, according to a California Healthline analysis of the FDA’s database of medical device incidents, known as the Manufacturer and User Facility Device Experience, or MAUDE. Hospitals, doctors, and others report device-related deaths, serious injuries, and malfunctions to manufacturers, who are required to investigate and report cases to the FDA.

In nearly 90% of those 4,500-plus reports, Thoratec said it found no problem with the device or how it was used, according to a California Healthline review of the FDA database.

In cases where Abbott finds the HeartMate 3 did not cause or contribute to a death or serious injury, the company files “corrective reports,” said Justin Paquette, an Abbott public affairs director.

He added, “The complexity of the device – combined with patients battling late stage heart failure and associated comorbidities – creates very dynamic clinical care situations.”

Abbott said the HeartMate 3 is the safest iteration yet of any left ventricular assist device, or LVAD, a type of mechanical heart pump introduced in the 1960s and refined over the last six decades.

The HeartMate 3 was first approved by the FDA, for use in patients awaiting a heart transplant, in August 2017, and one year later it was approved as a long-term therapy. The device is often considered only for patients with end-stage heart failure, and even then it is a last resort.

HeartMate 3 has “dramatically improved the safety of LVADs by reducing rates of complications that had historically challenged heart pump technology, including clotting, stroke and bleeding,” Paquette said.

As recently as August, the FDA also expressed support for the device. “The FDA believes the benefits of HeartMate 3 continue to outweigh the risks for this vulnerable patient population with few available alternatives,” said Jeremy Kahn, an agency spokesperson.

Others aren’t so sure. Former FDA medical device official Madris Kinard sees the high number of death reports as a warning.

“To me this is a safety signal and it’s hard to know if the FDA is working on something to address it,” said Kinard, founder of Device Events, a company that makes FDA device data more user-friendly for hospitals, law firms, investors, and others. “You have to wonder why [death reports are] still happening, and at the same rate.”

Larry Kessler, a former director in the FDA’s medical device office, agrees the death reports for HeartMate 3 need more study. “The FDA may be missing some signals,” he said. Perhaps “there’s a little more here than meets the eye.”

Not all device problems are reported to MAUDE, and submitting a report is not necessarily an admission that a device caused a death or a serious injury. Device problem reports can be inaccurate or incomplete, or lack verification, and a single incident may be reported more than once — or not at all.

Those limitations ultimately can leave patients and their caregivers uninformed about risks associated with a device such as the HeartMate 3, said Sanket Dhruva, a cardiologist and expert in medical device safety and regulation at the University of California-San Francisco.

“They’re making perhaps the biggest decision of their lives: Do I proceed with an LVAD or not? And even if I proceed, what are the risks I’m facing?” he said. “And they are left with incomplete data and uncertainty about how to make that determination.”

Even doctors cannot use the FDA database as a tool to effectively counsel patients, Dhruva added.

“lf you don’t know what is a real safety signal and what’s not,” he said, “then how can that information help us to calibrate our benefits-and-risks discussion with patients?”

Tracking Incident Reports

The HeartMate 3 is not the only device whose safety profile is hard to ascertain in MAUDE, Dhruva said. The information in the FDA database is insufficient to give patients an adequate understanding of any medical device’s safety risks and reflects “the overall weakness of postmarket surveillance” after a device has been approved for sale, he said.

Under federal regulations, device manufacturers typically must report adverse events to the FDA within 30 days of learning about them, and that data is often used by researchers and regulators to identify potential safety concerns. Reports also can be submitted voluntarily by doctors, patients, or others. The FDA says that reports don’t need to be filed if the manufacturer determines that a device did not cause or contribute to an adverse event.

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But with millions of reports for thousands of devices, it can be difficult to detect and prevent problems that put patients at risk.

Hospitals and surgeons also might self-censor what they report to manufacturers due to concerns about being sued, said Kessler, now a professor at the University of Washington.

“Health care facilities, and risk managers in particular, they aren’t always forthcoming with detailed data about events,” he said.

Reports in MAUDE show that patients with a HeartMate 3 have experienced adverse events, such as bleeding, infection, and respiratory failure, that the manufacturer warned were possible in its instructions for use.

About 400 reports cited infusion or flow problems with the HeartMate 3. In thousands of other cases, the manufacturer said it did not observe any problems with the device, making it even more difficult for a doctor or a patient’s family to understand the safety history of the product.

Reports in MAUDE also describe fatal incidents due to complications not mentioned in the manufacturer’s instructions, such as the locking mechanism malfunction. In one report, a patient died of smoke inhalation after an external battery charger caught fire.

Each report in MAUDE has dozens of data points and summaries describing what happened. What’s lacking in the database: context and details that would be useful for patients and doctors, such as the total number of devices in use and the name of the hospital where the event occurred.

Flores Blanco had never heard of MAUDE before her father’s surgery. Even if she had, it’s unlikely she would have found a locking mechanism issue amid the morass of records, much less anticipated what might happen.

Missed Signals?

A routine FDA inspection of Abbott’s manufacturing plant in 2017 showed that Thoratec had fallen behind schedule reporting adverse events, according to agency records obtained by California Healthline under a Freedom of Information Act request.

The company updated training and hired additional staff to handle complaints submitted by hospitals, doctors, patients, and others, according to an inspection report. It provided the FDA inspector with “quantitative evidence” that late reporting to the FDA had decreased.

By October 2020, during a follow-up inspection, Thoratec was using a database to enter and process complaints and submit device reports electronically, according to an inspection report.

FDA inspectors did not cite any deficiencies with how Thoratec handled complaints after the visit. Inspectors noted the company had received 8,115 complaints related to the HeartMate 3 during the 12 months prior to the inspection in October 2020, the records show.

It’s not clear what the complaints concerned. Abbott did not respond when asked how many of the complaints led to an adverse event report to the FDA.

In Kinard’s view, device-makers in general often take longer than 30 days to investigate the root cause of an incident and frequently conclude that an adverse event was due to user error.

“They are using this regularly to downplay the problems with the device,” she said.

In Herrman’s case, a Thoratec representative was in the operating room and witnessed the incident, according to a deposition in the lawsuit. The company submitted a report to the FDA about Herrman’s injury within 30 days of the June 2019 incident.

Herrman’s surgeon, John Stulak, was experienced at implanting the device, according to the lawsuit, and he was also a principal investigator on the clinical trial that brought the HeartMate 3 to market. Stulak did not respond to interview requests. But, in 2020, he and two Mayo Clinic colleagues described Herrman’s case in The Journal of Heart and Lung Transplantation, where they noted the locking mechanism malfunction. “The lack of a tight seal from this defect resulted in the multiple subsequent air embolism events and irrecoverable neurological damage,” they wrote.

The article describes how Stulak replaced the device with a new one, but it was too late to prevent the injuries to Herrman. Thoratec submitted at least three follow-up reports to the FDA about the incident and said its investigation could not determine whether the HeartMate 3 caused Herrman’s death.

Herrman’s death certificate cites complications of ischemic heart disease. Flores’ death certificate says he died of cardiac arrest and hypoxic ischemic encephalopathy, or brain damage.

The FDA has had its own problems keeping the MAUDE database up to date.

The agency is years behind schedule on anonymizing and releasing adverse event reports for all medical devices.

Kinard said the FDA has yet to publicly release “millions” of follow-up reports that manufacturers have filed after their initial adverse event report for a medical device.

The FDA acknowledged that the agency is not up to date on public reporting but could not say how many reports are pending — for the HeartMate 3 or any device.

“We are currently working on redaction for public posting in MAUDE, of all supplemental reports dated 2021-2023,” said Kahn, the FDA spokesperson. “It is difficult to determine how many of those – pending redaction of supplemental reports – pertain to the subject device.”

FDA press officer Lauren-Jei McCarthy noted that, besides adverse event reports, the agency also monitors published literature, patients, patient advocacy groups, professional societies, individual health care providers, and other sources to determine whether further action is warranted.

“We review and take seriously all reports of adverse events associated with medical devices,” McCarthy said. She said patients and providers who use the HeartMate 3 “remain a high priority” and that the agency cannot comment on investigations.

A Last-Resort Treatment

Before he got a HeartMate 3 implanted in January 2022, Sid Covington, of Austin, Texas, said he had researched the device during years of medication therapy and cardiac rehabilitation to treat his congestive heart failure.

“I looked at case studies. I looked at a number of the different heart studies,” Covington said. “I looked at their marketing brochures and all that stuff, just whatever I could find.”

Covington, 76, said he was familiar with MAUDE and Intermacs, a private registry that tracks LVAD patients, but didn’t consult them. When he had to decide whether to get the device, he was in the hospital with chest pain, shortness of breath, and fatigue from advanced heart failure. Covington said his only option was the HeartMate 3.

“When it comes down to the moment, you really don’t have much choice,” he said. “It’s any port in the storm at that point.”

The HeartMate 3 requires constant attention and care from patients, who must keep the external parts of the device dry at all times and avoid jumping and contact sports. Patients must also ensure that it always has an external source of power, which is supplied through a cord attached to the pump that exits the body through a surgical opening.

Patients who get the device are often out of options to treat their end-stage heart failure, said Larry Allen, a cardiologist with the University of Colorado and member of a multidisciplinary medical team that cares for heart failure patients.

“We wouldn’t proceed with an LVAD unless we think the risk of death is really high and we’ve tried everything else,” he said.

That informs the regulatory view, too, Kessler said.

“When you’re talking about people who are seriously ill, then the FDA will accept a potentially higher risk,” he said, “but not an irresponsible one, and certainly not one that couldn’t be communicated to clinicians and the public.”

Allen, who helped develop a decision aid for patients considering an LVAD, said reliable data on safety and risks to patients is key.

“It’s about as high-risk, high-reward a choice as there can be,” Allen said. “It’s a really complicated decision to make and I think standard informed consent approaches are really inadequate for fully understanding that.”

Data Exists but Is Confidential

Long-term data for the HeartMate 3 — including performance metrics for the more than 180 U.S. hospitals certified to implant the device — are kept in Intermacs, managed by The Society of Thoracic Surgeons, which has promised to provide transparency but has yet to deliver.

The registry tracks mortality and injury rates for patients with an LVAD and logs the number of devices implanted each year.

But Intermacs is proprietary, and access at hospitals requires a principal investigator and at least one trained staff member, who can use the data to evaluate their facility’s performance against an aggregate from their peers across the nation.

Francis Pagani, a heart transplant and LVAD surgeon at University of Michigan Health, leads a medical society task force that oversees Intermacs. He said 12,000 to 14,000 HeartMate 3 implants have been recorded in Intermacs since 2017. The HeartMate 3 has “the best outcomes of any other LVAD, ever,” he said.

Over the years, federal regulators have made it easier for patients to access LVADs, reducing surgery volume requirements for implant centers and no longer requiring patients to be on a transplant waiting list to receive one of the pumps.

Though the HeartMate 3 is presently the only LVAD being implanted in the United States, it once had a competitor, Medtronic’s HeartWare, which the manufacturer removed from the market in June 2021, citing a high risk of stroke and pumps failing to restart if stopped.

While the FDA provides consumers with concise information about key clinical trials supporting the approval of new drugs, the agency provides no comparable data for medical devices. And though Medicare reimburses hospitals nearly $200,000 for most HeartMate 3 implants, federal administrators do not track patient outcomes or enforce performance standards for the heart pumps.

James Kirklin, a cardiac surgeon and researcher, was the principal investigator for Intermacs when the FDA, Centers for Medicare & Medicaid Services, and National Heart, Lung, and Blood Institute awarded a contract to the University of Alabama at Birmingham to establish the registry in 2005.

Federal agencies paid about $15 million over 10 years for Intermacs, Kirklin said, because they wanted to better understand the risk factors for death and other adverse events with so-called mechanical circulatory support devices, including LVADs, as well as the factors that indicated a higher likelihood of patients doing well on the pumps.

The FDA monitors annual reports of Intermacs data, including adverse events, and allows companies to use the registry’s data to analyze their devices’ performance and to fulfill reporting requirements after a device enters the market.

LVAD implant centers are required to report their data to Intermacs in order to be certified by the accrediting nonprofit The Joint Commission. And while CMS requires that centers implant at least 10 devices every three years to continue receiving Medicare reimbursement, there are no requirements for outcomes or other quality metrics. CMS does not track LVAD patient outcomes at individual facilities, said Sara Lonardo, CMS press secretary at the time.

Kirklin said he is working with The Society of Thoracic Surgeons to create a risk model that would allow the public to see quality scores for individual hospitals that implant LVADs, a need the group has recognized since at least 2018. But it will be a year before the tool is ready.

Kirklin and Pagani said the number of death reports for the HeartMate 3 in the FDA’s MAUDE database can be misleading without the outcome and longitudinal perspective that Intermacs provides.

“When you see a lot of deaths it means, ‘Let’s investigate.’ I couldn’t agree more,” Kirklin said. “But it’s rather limited. It’s not time-related and you don’t know the denominator. If you look up Intermacs, it’s all there.”

The families of Herrman and Flores filed lawsuits, in part, to find out what went wrong. Herrman’s family settled the lawsuit and agreed to confidentiality. Thoratec has filed a motion to dismiss the ongoing Flores case based on the FDA’s approval of the device.

Alanna Flores Blanco said she and her father were aware of the HeartMate 3’s positive outcomes, including published research that shows those who receive the device have a better than 50% chance of living five years or more.

“That’s why he took the chance to do it,” she said.

Flores Blanco said her father was a model patient, meeting regularly with cardiologists and other specialists, attending classes to learn how to live with the device, and receiving approval for surgery from the medical review board at Methodist Hospital in San Antonio.

The family felt informed and her father was prepared, she said.

“He did everything he was supposed to do,” she said. “What failed him ultimately was that device.”

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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A student ran for help. Firefighters arrived and hoisted Little onto a gurney. At the hospital, an X-ray revealed that the artificial hip implant in Little’s right leg had “suddenly and catastrophically structurally failed,” according to a lawsuit Little would later file in federal court. The implant severed at its “neck” — a 2-inch-long titanium part linking Little’s thigh to his torso.

“It looked like a laser went through it,” Little said in an interview. “It was like someone just went in there and cut it right in the middle.”

Profemur artificial hips were once considered innovative for a feature known as a “dual modular neck,” intended to modernize total hip replacement surgery. Hundreds of thousands of Americans undergo hip implant surgery each year and devices are expected to last at least 20 years, according to the American College of Rheumatology. The Profemur necks, available in an array of lengths and angles, made it easier to customize the hip implants for patients.

But the neck also proved to be a weak point. Over the past two decades, more than 750 Profemur hips like Little’s have fractured at the neck, an attorney for the manufacturer once said in court while defending the device as not defective. In interviews, patients said they were left unable to walk and in need of emergency surgery. Reports submitted to the FDA describe Profemur patients stranded in the midst of routine life, while hiking, golfing, bowling, mowing the lawn, lifting a potted plant, getting out of a chair, putting on pants, and leaning over to pick up a key.

After each break, patients endure an hours-long repair surgery that can be traumatic because the broken implant is embedded in their bone and difficult to remove, according to three orthopedic surgeons who’ve performed such a procedure. The repair surgery, which can cost tens of thousands of dollars and may not be fully reimbursed by insurance, often requires a patient’s femur to be cracked open to extract a metal stem that was inserted down its length. Lawsuits have likened removing the bone around the stem to peeling a banana.

“It’s gruesome,” said Lee E. Rubin, an orthopedic surgeon and expert on prosthetic hips at Yale School of Medicine. “There’s no way around the fact that there’s a failed or broken implant in that patient’s thigh. We have to remove it.”

Many Profemur fractures in patients’ bodies could have been avoided if the manufacturer or the FDA responded to early signs of failure with more urgency, according to a months-long investigation by KFF Health News and CBS News. An FDA database shows reports of Profemur’s titanium modular necks breaking inside U.S. patients since at least 2005, but the corresponding parts were not recalled until 15 years later, if at all. Ten sizes of the titanium neck eventually were recalled in 2020 after being identified in more than 650 reports of fractures submitted to the FDA. Six other sizes of titanium necks, identified in about 75 additional fracture reports, have not been permanently recalled.

Aidin Eslam Pour, another Yale orthopedic surgeon who has studied Profemur fractures, said the manufacturer “waited too long.”

“This implant should have been pulled out of the market earlier,” he said.

Profemur’s original manufacturer, Wright Medical Technology, in 2009 switched the metal of the modular neck from titanium to a stronger cobalt-chromium alloy, FDA documents show. Then, after some of those necks also began to break, the company recalled one size but left 11 others on the market despite reports of corrosion causing the implants to fail, FDA documents show.

In total, at least 28 sizes of the Profemur artificial hips with a dual modular neck have allegedly fractured or corroded, but just 11 sizes have been permanently recalled, according to FDA data and records.

Wright Medical, a Tennessee company founded in 1950, has made implantable medical devices since at least the 1970s, according to the company website. Wright sold its hip and knee implant division, including the Profemur, to Chinese company MicroPort for $285 million in 2013, according to the Securities and Exchange Commission. Stryker Corp., one of the nation’s largest device companies, paid about $4 billion for the rest of Wright in 2020.

Wright Medical declined to comment in an email from Stryker spokesperson Jon Zimmer. MicroPort did not respond to more than a dozen requests for comment sent to its attorneys, public relations firm, and U.S. offices. MicroPort still advertises Profemur hip implants with dual modular necks on its website, where the devices are listed as “not marketed/registered in United States.”

The FDA declined to provide an official for an interview and did not answer written questions about why some Profemur sizes were not permanently recalled. In an email, FDA spokesperson Audra Harrison said medical device manufacturers are largely responsible for deciding which products to recall and when to do so, while the agency “monitors” this process and requests recalls only in “urgent situations.” In the case of the Profemur modular necks, all recalls were initiated by MicroPort, and the FDA “took action accordingly,” the agency said.

For this investigation, journalists with KFF Health News and CBS News analyzed thousands of reports of Profemur complications submitted over the past two decades to the FDA’s nationwide MAUDE database, which catalogs reports of medical device problems and malfunctions. MAUDE is unverified, incomplete, and imperfect — for example, not all device problems are properly submitted to the database, and a single issue may be reported more than once. However, the database still offers the best available perspective on medical device complications in the United States. The FDA has used MAUDE to identify device problems since the early ’90s.

KFF Health News and CBS News also reviewed about 180 lawsuits filed in federal court in the past decade alleging Profemur modular necks broke or corroded. Plaintiffs have alleged severe pain, swelling, a “debilitating lack of mobility,” and, in at least a few cases, nerve damage and neurological issues from cobalt and chromium ions leaking into their bloodstream.

Most of the lawsuits have been resolved through out-of-court settlements without Wright Medical or MicroPort publicly admitting fault, according to court filings. The remainder of the lawsuits are ongoing.

Wright Medical has denied liability in some lawsuits before settling them and has defended Profemur implants in court in the years before some of the implants were recalled for fracturing.

“A device fracture does not mean it is defective,” Wright Medical attorney Tiffany Carpenter said in federal court in 2018, according to a hearing transcript. “Devices fracture all the time.”

Collectively, the lawsuits allege that Profemur artificial hips broke or corroded at the neck in about 7½ years, on average. Profemur necks made from titanium broke on average in about 10 years while necks made from the cobalt-chromium alloy broke or corroded in just six years, the lawsuits allege.

Some plaintiffs say they got Profemur implants in both legs — then they both ended up breaking.

Mark Feld, 75, of New Hampshire, who was an avid runner, said he was implanted with Profemur artificial hips in his right and left legs in 2005 and 2008, then the right hip fractured within 10 years, according to a lawsuit he filed. Wright Medical denied liability in court filings and settled out of court for an undisclosed amount.

Feld said that because he surrendered all claims against Wright in the settlement, he could not sue again when his left implant broke in 2020 as he was walking across a bridge near his apartment.

He crawled home to call 911, he said, and was rushed to the hospital.

“I couldn’t walk across that bridge for a year,” Feld said. He now has new hip implants made by another company, but his fear lingers. “To this day, I still feel like a ticking time bomb. …  Nobody could confirm for me that it can’t happen again.”

Little, the Arizona teacher, also suffered a second Profemur break, four years after his first, according to his lawsuit, in which Wright Medical denied liability and settled out of court. Little said in an interview that this time he was teaching class on a tennis court when he felt a sensation in his left leg that reminded him of crushing an aluminum can. He said he narrowly avoided tumbling onto his students.

After his two broken hip implants and replacement surgeries, Little said, he had to stop coaching basketball and will retire from teaching at the end of this school year — four years earlier than planned. He still feels unsteady and is afraid to climb a stepladder to change a lightbulb, he said.

“I’ve been robbed of some things,” Little said. “There should be accountability for it.”

It is not publicly known how many Profemur hips have failed. According to a federal court transcript, Carpenter, the attorney for Wright Medical, said in court in 2018 that the company was aware of 768 fractures among about 353,000 Profemur necks sold. That’s a fracture rate of about 0.2%.

Other sources report a much higher rate. The Profemur devices that were permanently recalled in 2020 had a U.S. fracture rate of 2.2% — 11 times what was described in court — according to FDA documents. Peer-reviewed studies estimate fracture rates as low as 1% and as high as 6% for some Profemur models.

Even the lowest estimates are “unacceptable,” said Samo Fokter, an orthopedic surgeon and Profemur expert at University Medical Center Maribor in Slovenia.

Fokter has co-authored more than 10 peer-reviewed studies on the Profemur, including one this year, and said he implanted about 50 of them before they were known to fracture.

“This should not happen,” Fokter said. “If you put too much force on any implant, it can fracture, of course, but this is very, very rare. Not approaching 1%. It should be less than one in 100,000, let’s say.”

‘Like a Black Hole Developed Under Their Foot’

The Profemur’s problems originate from its “neck,” which is a metal connector between the upper components in the hip socket to a lower “stem” that is inserted into a patient’s thigh bone, according to peer-reviewed studies, court records, and expert interviews.

Historically, an artificial hip’s stem and neck were a single piece of metal. The Profemur line added a junction at the top of the stem so the neck was separate. Because these dual modular necks detached on both ends, the size and angle could be changed to better fit a patient.

But the Profemur’s additional junction was also its downfall. Rubin, one of the Yale experts, who also maintains an exhibit of the history of prosthetic hips at the university, said in some patients tiny cracks formed on the portion of the neck that slotted into the socket of the stem. Patients had no idea their implant was cracking until the neck snapped, he said.

“From a patient’s perspective, they’re walking around on what otherwise would seem like a successful hip implant,” Rubin said. “And all of a sudden, as they took a step, they could not bear weight … like a black hole had developed under their foot.”

The dual modular neck was developed by a European company, Cremascoli Ortho Group, in the ’80s, then purchased by Wright Medical in 1999 to be introduced as the Profemur in the United States. The Profemur was cleared for sale by the FDA in 2000 through the 510(k) program, which permits new medical devices to be sold without extensive testing if they are deemed to have “substantial equivalence” to other devices already on the market. Through this process, new medical devices can piggyback on a single approval for decades.

Wright Medical told the FDA that the Profemur was substantially equivalent to five existing artificial hip systems, and the agency agreed, according to FDA documents obtained through a Freedom of Information Act request. However, of those five hip systems, at least three had significantly different necks than the Profemur, Rubin said. And one was later recalled because of its high failure rate, according to the FDA.

The FDA documents state that although the Profemur is different from the older hip implants that its approval was based on, those differences were “not expected to affect the device’s safety and effectiveness.” Spokesperson Harrison said in an email that the FDA “followed the statutory framework” when the Profemur was reviewed and cleared.

Once it was cleared by the FDA, Wright touted the Profemur’s dual modular neck as a feature.

In a 2004 promotional document obtained by KFF Health News and CBS News, Wright guaranteed the “structural reliability” and “absence of fretting corrosion” at the junction of the stem and neck. Then Wright marketed the Profemur to people with an “active lifestyle,” saying the product was for patients who wanted to return to activities like golf, tennis, karate, and wrestling after their hip replacements, according to at least two dozen lawsuits filed against the company.

Wright also hired Jimmy Connors, who was the world’s top-ranked tennis player in the ‘70s, as a spokesperson.

“This hip has given me back my quality of life. It’s allowed me to do anything I did before,” Connors said on JimmysNEWHip.com, a website launched by Wright in 2006, according to screen captures of the site preserved by the Internet Archive.

When the website launched, Wright Medical knew of at least some reports of modular neck fractures. Multiple lawsuits allege the company was aware as of 2000 that some Cremascoli hips had fractured at the modular neck, and then became aware of more fractures in 2003 and 2004. The FDA database shows Wright was also aware of two Profemur implants that allegedly fractured at the neck and were returned to Wright in spring 2005.

In 2006, FDA data showed six reports of Profemur fractures that identified the neck as the part that allegedly broke. By 2007, there were 11 such reports. By 2008, there were 30.

Connors, reached on his cellphone, said Wright Medical did not inform him of Profemur fractures at the time of his endorsement or since. Connors said his own hip implant did not fracture but had to be replaced in 2012 because of other complications.

If he had been told about a fracture risk, Connors said, he might have chosen another implant.

“If I was going through it now, I’d know a lot more to ask than I did back in the first time,” Connors said.

Perry Parks, 79, who played football for the Los Angeles Rams in the ’60s, said Connors’ endorsement persuaded him to get a Profemur hip in 2007. His implant snapped six years later during a bike ride, according to his lawsuit. Wright Medical denied liability and settled out of court.

In an interview, Parks said he was lucky to be biking at the beach at the time of the break, where he tumbled into sand, instead of in traffic.

“The thing that incenses me more is that they knew this,” Parks said. “There was some intentionality here to put … profits over the health of people.”

New Metal, New Complications

In 2009, Wright Medical introduced a new version of the Profemur modular neck that once again was cleared for sale by the FDA. Agency documents show that the neck material was switched from titanium to a cobalt-chromium alloy, a stronger metal.

“That was a big mistake,” Fokter said.

While the cobalt-chromium necks were less susceptible to fracture, they created a new problem at the same junction between the neck and stem, said Fokter and the two Yale experts. Once implanted, the cobalt-chromium neck could rub against the stem’s titanium socket, leading to a form of bimetallic corrosion that can cause pain and swelling and leak small amounts of metal ions into a patient’s bloodstream, potentially causing a long list of complications, the three experts said.

Robert Rembisz, 75, a retiree in Vero Beach, Florida, alleged in an ongoing lawsuit that Profemur corrosion in his right leg caused elevated metal levels in his blood and “neurologic symptoms” including nerve damage, tinnitus, and balance and coordination problems. Wright Medical has not yet responded to the allegations in Rembisz’s lawsuit.

Rembisz added in an interview that he believes the implant hindered his memory and cognition, leading him to question whether he was suffering early signs of dementia. He provided to KFF Health News and CBS News lab reports showing the metals in his blood rising over years, with cobalt levels peaking at nearly 12 times the normal range. Rembisz said most of the symptoms faded after his implant was removed in 2021.

“The problems I developed weren’t even close to my hip,” Rembisz said. “This problem could be occurring in [other people’s] bodies as well. And they don’t even know it.”

Six years after Profemur switched metals, MicroPort recalled one size of the cobalt-chromium neck affecting about 10,500 implants, citing an “unexpected rate of postoperative fractures,” according to FDA records. But it is unknown how many could not be returned because they’d already been implanted.

Kristin Biorn had one.

Biorn, 74, of Pasadena, California, alleged in a lawsuit that this particular size of Profemur neck was implanted in her left leg in 2013 and broke within two years — four months before the recall. Wright Medical and MicroPort denied liability in her lawsuit, then settled out of court.

In an interview, Biorn said the break occurred as she was working at her burgeoning home-staging business. While putting final touches on a client’s home with her teenage son, she fell to the floor, unable to stand or crawl, she said.

“Honestly, it gives me nightmares about what could have happened had my son not been there,” Biorn said. “My phone was downstairs and there was no way I could have gotten down the stairs alone. No one was scheduled to come in for four days.”

Biorn said in her interview that it took three surgeries to fix her hip after the Profemur fracture and she was ultimately forced to close her business and retire.

She now walks with a cane.

Although MicroPort recalled one cobalt-chromium size in 2015, the company did not recall 11 other sizes made of the same metal with the same design, and some lawsuits have faulted the company for leaving “interchangeable” products on the market. MicroPort also did not at that time recall any of the titanium necks, which as of 2015 were identified in more than 500 fracture reports in FDA’s database. MicroPort recalled 10 titanium sizes in 2020.

Finally, also in 2020, MicroPort issued a sweeping recall for all available Profemur modular necks, regardless of whether they were made of titanium or cobalt-chromium, according to FDA records.

The recall was temporary so MicroPort could update the documents included in the packaging of Profemur implants. The revised documents added a “general precaution” that doctors should consider a patient’s activity level and weight before implanting them with a Profemur, and said that patients should not have “unrealistic” expectations that include “substantial walking, running, lifting, or muscle strain.”

Afterward, the recall was lifted, and the FDA once again allowed the implants to be put up for sale.

KFF Health News data editor Holly K. Hacker and CBS News producer Nicole Keller contributed to this report.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced — a painful and debilitating operation.

“The surgery was a huge debt of pain paid over months,” said Irby, 71, a Gainesville resident and retired medical technologist with the Department of Veterans Affairs.

Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. A letter Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants. Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.

Although Exactech does not offer an express warranty on its products, the company stresses the durability of its implants in advertising, even suggesting they likely will outlive their human recipients.

Exactech, which grew over three decades from a mom-and-pop device manufacturer into a global entity that sold for $737 million in 2018, declined comment, citing the “ongoing litigation,” said company spokesperson Tom Johnson. In court filings, Exactech has argued that its products are not defective and have “an excellent history.”

A California Healthline review of thousands of pages of court filings in patient lawsuits, a pending whistleblower lawsuit, and other government records shows that the company is being accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. In hundreds of instances, according to government records, the company took years to report adverse events to a federal database that tracks device failures.

In his suit, Irby alleges that Exactech “knew or should have known” that the Optetrak “had an unacceptable failure and complication rate.” He said Exactech used packaging materials of “an inferior grade or quality.”

“I think they were cutting corners to improve their bottom line,” Irby told California Healthline.

Exactech denied the allegations in a legal filing in Irby’s suit, in which it described the Optetrak device as “safe and effective.”

A Family Affair

Surgeon William “Bill” Petty chaired the orthopedics department at the University of Florida in Gainesville, when he, his wife, Betty, and Gary Miller, a biomedical engineer and fellow faculty member, formed Exactech in November 1985. The Pettys served in corporate roles until retiring in early 2020. Their first hire was their son David in 1988, who remains on Exactech’s board of directors.

Exactech’s fortunes started to take off in 1994, when it inked a major deal to license and market the Optetrak knee implant based on designs by surgeons and engineers at the prestigious Hospital for Special Surgery in New York City. That alliance won Exactech instant credibility in the fiercely competitive device industry.

So did its pedigree as a “surgeon-focused” business with a family-run vibe, small enough that surgeons considering its wares could meet the owners and tour its Florida plant.

Building on that goodwill, Exactech’s sales shot past $124 million in 2007, about half generated by the Optetrak knee system.

“It’s not just a road we’re on, it’s a trail we’re blazing,” the company boasted in sales literature aimed at surgeons.

Exactech’s corporate confidence belies years of warnings and doubts about the durability of the Optetrak, according to whistleblowers — one whistleblower called it an “open secret” inside the company. Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.

For starters, several surgeons complained that the knee implants loosened prematurely, causing patients pain and limiting their ability to move around, court records allege.

While 95% of artificial knees should last at least a decade, surgeons had to pull out and replace many Optetrak components — a complex operation known as revision surgery — much sooner, according to allegations in patient lawsuits.

Christopher Hutchins, a Connecticut orthopedic surgeon who relied on the Optetrak finned devices for more than 350 knee surgeries, said in a court deposition that some loosened in as little as two to three years. He called that “awfully premature” and “extraordinary.”

Hutchins vented his frustrations in a brief meeting with Exactech co-founder Bill Petty at a Rhode Island hospital in either 2006 or 2007, according to his deposition. Petty told him at the meeting he “realized that it was a problem” with the device, according to Hutchins.

“I was somewhat struck that if they knew there was a problem why it wasn’t being addressed and why the product wasn’t being pulled from the market,” Hutchins testified in the November 2021 deposition.

“There was no disclosure or transparency.”

Older patients not only suffered physical pain, but also felt an “emotional burden” from facing revision surgery in which results often are “not as good as the first go around,” Hutchins explained during his deposition testimony.“I’m in the business to try to make people better, and when things fail, I take it to heart.”

Hutchins was not the only surgeon alarmed by what he says were early failures of the Optetrak devices and the company’s tepid response.

‘Popping Out’

In August 2005, Maine orthopedic surgeon Wayne Moody told company officials that Optetrak had loosened and needed to be revised in 25 out of 385 operations he had performed over the previous four years, according to meeting minutes filed in court.

One knee implant gave out in just nine months, Moody told the group, according to the minutes.

In a deposition, Robert Farley, a former Exactech sales agent who filed a whistleblower lawsuit in 2018 alleging fraud by the company, alleged that he heard two colleagues joke about Moody’s tribulations at a national sales conference.

Moody “probably had 50-something revisions. … They’re just popping out right and left,” the sales agent said, according to Farley’s suit.

Fellow whistleblower Manuel Fuentes, a former Exactech senior product manager, testified in a deposition that pulling the product off the market around 2008 “would have been the ethical and moral thing to do.”

At a meeting in early 2008 attended by the company’s top brass, including Bill Petty, the company’s marketing director at the time, Charley Rye, floated the idea of a recall, Fuentes said. Company executives shot that down as “financially detrimental,” Fuentes testified in a sworn declaration filed with the court.

Asked about the meeting during a December 2021 deposition, Petty replied, “I don’t recall that anyone suggested a recall.”

‘Silent Recall’

Exactech discussed the loosening problem in an internal memo that said between 2006 and 2009 the company “began to get some negative feedback” about the Optetrak “that was at times confounding and difficult to process,” court records show.

The discouraging reports ranged from complaints of early revisions from at least 10 U.S. surgeons and surgery practices in several of the more than 30 countries where Exactech sold the implant, court records show.

The results did little to dim Exactech’s prospects. From 1994 through April 2022, Exactech sold 58,763 Optetrak devices with finned trays for use by 514 surgeons nationwide, according to an affidavit by a company official.

Many lawsuits argue that instead of warning patients and surgeons about the loosening problem, Exactech replaced the finned tray component in its newest products, a strategy device industry critics refer to as a “silent recall.” Exactech denies that and said in a court filing that design changes it made were part of a “natural evolution” of the Optetrak.

Even as Exactech rolled out newer generations of the Optetrak, the company faced lawsuits and other criticism alleging it had failed to come clean about unusually high surgical revision rates.

Late Notices

The Food and Drug Administration runs a massive, public, searchable databank called MAUDE to warn the public of dangers linked to medical devices and drugs.

Manufacturers must advise the FDA when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.Those reports must be submitted within 30 days unless a special exemption is granted.

But court and government records show that reports of adverse reactions tied to Exactech’s implant sometimes took years to show up in the government database — if they were reported at all.

Exactech failed to advise the FDA of dozens of Optetrak early revision complaints lodged by orthopedic surgeons Moody and Hutchins, a company representative acknowledged in a court filing.

California Healthline downloaded the FDA data and found about 400 examples in which Exactech reported adverse events to the MAUDE database two years or more after learning of them.

FDA inspectors who combed through Exactech’s internal files in 2017 cited the company for failing to undertake an “adequate investigation” of complaints, according to FDA records cited in court filings.

In court filings, Exactech steadfastly denied Optetrak has any defects. Instead, it blamed the loosening problem on surgeons, saying they had failed to cement the knee implants into place correctly or misaligned them.

The company said it had no obligation to report poor outcomes tied to mistakes by surgeons — even though the FDA requires companies to report injuries involving “user error.” In 2022, a federal judge in the whistleblower case, in denying a motion to dismiss, found that Exactech was “hard-pressed” to claim it was not obligated to report the adverse events.

The three whistleblowers are accusing Exactech of fraud for allegedly selling defective products to Medicare and other federal health care programs. The case is pending in federal court in Alabama and Exactech has denied any wrongdoing. Exactech in mid-August filed a motion to dismiss the case.

Lawyers for more than 300 injured patients suing in Alachua County Circuit Court in Florida are pressing for full disclosure of 2,435 complaints to the company alleging deficiencies with Exactech knee products, which the company admits receiving as of the end of April.

In other pending lawsuits, patients argue the company pointedly ignored evidence of chronic safety issues to fuel profits.

Keith Nuzzo, of Litchfield, Maine, is one. He alleged that Exactech “cut corners, utilized inferior manufacturing practices … [and] only disclosed information or took corrective action if contacted by regulatory authorities.”

Nuzzo had a right knee replacement done by orthopedic surgeon Moody in February 2012 and a left knee implanted a week afterward.

His right knee became painful and wobbly about four years later and a second surgeon replaced it in August 2016. The left knee gave out in November 2020, also requiring replacement, according to the suit.

Despite the revisions, Nuzzo lives with “daily knee pain and discomfort,” which limits his “activities of daily living and recreation,” according to the suit. The case is pending. As of mid-September, Exactech had not filed an answer.

No Guarantees

In advertising directed at surgeons, Exactech boasts about the long life of its implants.

One sales brochure states that the Optetrak “demonstrated 91-99 percent implant survival rates” over just under a decade. That is consistent with, if not superior to, industry standards, though as a rule of thumb many surgeons expect implants to last 15 to 20 years, sometimes longer.

The mounting legal claims allege many Exactech knee and hip implants have worn out well before their time.

The California Healthline analysis of more than 300 pending cases in Alachua County found that surgeons removed about 200 implants after less than seven years. Some people in the sample, whose surgeries spanned more than two dozen states, were awaiting revision procedures. In the federal court sample, patients alleged that half of the 400 implants that were removed lasted less than six years.

Advertising materials aside, Exactech is circumspect in describing the reliability of its implants when it speaks to courts. In a 2021 filing, the company noted that the Optetrak comes with no express warranty.

How long it lasts “depends on a multitude of factors, including those pertaining to surgical technique and the particular patient,” the company said.

Promoting the Products

Exactech’s focus on its surgeon customers includes paying handsome consulting fees to some orthopedists who have used the company’s implants in the operating room or promoted them in advertising.

Exactech paid surgeon consultants $23.2 million combined from the start of 2013 through the end of 2022, the most recent year available, according to a government database called Open Payments.

In promoting the Optetrak in sales materials, Exactech touted “excellent results” achieved by orthopedic surgeon Raymond Robinson. Left unsaid: Exactech paid Robinson more than $900,000 in consulting fees and other payments from 2013 through 2022. In a court filing, Exactech denied any consultants “were compensated in exchange for product promotion.” Robinson could not be reached for comment.

Exactech’s sales brochures also boast that surgeons “around the world have documented excellent results with the Optetrak knee system.”

Yet Exactech bottled up a succession of sharply negative reports from other countries, while working to discredit others, according to internal company records filed in court by the whistleblowers.

One surgery group in France concluded in 2012 that nine of 110 Optetrak procedures required revision due to loosening in under three years, for instance. Exactech disputed the findings in a published response, and in a court filing said the conclusions were “based on incorrect information and a flawed understanding of the true causes.”

A hospital in Buenos Aires, Argentina, reported that 25% to 30% of Optetrak knees required revisions in under two years, according to whistleblower Fuentes.

The Australian implant registry criticized Optetrak’s reliability as early as 2007 and in several later years. In response, Exactech executives said in depositions and court filings that they traced many of the poor results to a single hospital and three surgeons who failed to align the implants correctly.

The Australian registry pegged Exactech’s revision rate at 19.4% at seven years and 22% at 10 years, the worst of any knee implant on the market, which led the government health system to stop purchasing it, court records allege. Exactech denied the allegations in a court filing.

James Brooks, a retired Texas orthopedic surgeon, said in a court affidavit that he believed Exactech had an obligation to tell surgeons about the poor outcomes overseas rather than touting rosy results tied to doctors on its payroll.

In the 2021 affidavit, Brooks recalled implanting the Optetrak knee in a Dallas man in 2011, only to confirm from X-rays that it was failing in 2017 and needed to be replaced two years later. Brooks said he would have steered clear of Optetrak had he known of its “much higher failure rate than comparable products.”

Clicking Sounds

Laura Grandis is suing Ohio orthopedic surgeon and Exactech consultant Ian Gradisar, who received $132,720 from the company, including research payments, from 2013 through 2022, according to government records.

Gradisar’s father, Ivan, also an orthopedic surgeon, served on the original Optetrak design team. In 2008, Ian Gradisar helped his father with an audit of “patient outcomes” commissioned by Exactech. The audit showed that 12 of 47 Optetrak patients operated on over the course of 15 months required revisions, giving the son “first-hand knowledge of the failing and defective Optetrak,” Grandis alleges in her suit.

Ian Gradisar put an Exactech implant in Grandis’ left knee in Akron, Ohio, in November 2020.

In early 2021, she had “severe” pain in her knee and needed a cane or a walker to get around, according to the suit.

Gradisar told her the knee had failed, which he said was “very rare and only happened 5% of the time,” according to the suit.

Grandis had revision surgery in July 2021 with an Optetrak implant. Some seven months later, she felt pain that worsened throughout the day. She tried ice and rest, but that did not work. Her knee hurt when she put weight on it and started making a clicking sound when she moved, according to the suit.

In June 2022, Grandis received a “Dear Patient” form letter from the hospital where her surgery was performed notifying her of the Exactech recall.

Gradisar’s office told her the surgeon could not see her until October 2022 “as he was inundated with phone calls from patients about the Exactech recall,” according to the suit.

In response to the suit, Exactech denied the allegations, including that its knee implants had “increased failure rates.” The case is pending. Gradisar and his lawyer did not respond to requests for comment.

But in a court filing, Gradisar denied any defects in the implant and said he “provided quality care and treatment” to Grandis.

In December 2022, Grandis ended up having a second revision operation that kept her hobbling around on crutches for six weeks, according to her suit.

Total Recall

Two years after the initial recall, Exactech and its owners — past and present — face a rush of lawsuits demanding accountability for alleged patient injuries.

Most of the suits in the Alachua County group name Bill, Betty, and David Petty and Miller as defendants for their roles at Exactech. Their attorney did not respond to requests for comment, but in May, the defendants jointly filed a motion to dismiss, arguing that the suits fail “to allege sufficient facts to impose liability.”

Many suits in the federal court cluster also name as a defendant TPG Capital, a Texas-based private equity firm that paid $737 million to acquire Exactech in February 2018. TPG declined to comment but has filed a motion to dismiss the cases.

In one recall letter sent to surgeons, Exactech acknowledged that the data from the Australian registry confirmed that Optetrak had “statistically significant” higher rates of revisions than knee implants made by other companies — a conclusion it had previously disputed.

The letter adds that Exactech is “uncertain” if the packaging defect is the “root cause” of Optetrak’s poor performance. An FDA “safety communication” issued in March said the agency is working with Exactech to assess whether other implants packaged in the defective bags pose similar risks.

Exactech lawyers say the company may not be to blame for every implant that wears out unexpectedly.

In a November 2022 hearing, Exactech attorney Michael Kanute said wear of polyethylene implant components is a “known risk no matter who makes them.” He said the patient’s size and activity level as well as the technique of the surgeons could also be factors.

“So every case is different,” he said.

KFF Health News data editor Holly K. Hacker and reporter Megan Kalata contributed to this report.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Multiple lawsuits allege the device has caused grievous harm to at least 20 patients and the FDA is now investigating its safety, KFF Health News and CBS News have reported.

The AGGA is a retainer-like device promoted by some dentists as an option for expanding adult patients’ jawbones, beautifying their faces, and curing common ailments like sleep apnea. The lawsuits have alleged patients suffered damaged gums, eroded bone, and, in some cases, lost teeth.

The criminal investigation of the use of the AGGA was revealed in a court motion that seeks to delay the largest of the lawsuits “pending the outcome of any criminal proceedings.” The motion was filed this month by attorneys for AGGA inventor Dr. Steve Galella, his company, the Facial Beauty Institute, and AGGA manufacturer Johns Dental Laboratories, who said the investigation is being conducted “for the purpose of potentially bringing criminal charges” against their clients.

The attorneys said in their court filing that there is “no doubt” the investigation arose from the KFF Health News-CBS News coverage of the AGGA.

“The U.S. Attorney’s Office for the Western District of Tennessee and the U.S. Department of Justice is currently conducting a criminal investigation which, it is anticipated, will ultimately result in the presentation of evidence to a grand jury relating to the facts in this case,” the attorneys state in the court filing in support of the motion.

None of the court records suggests what criminal charges could result from the investigation.

The U.S. Attorney’s Office in Memphis, which generally does not discuss ongoing investigations, declined to comment. Scott Charnas, an attorney representing many AGGA patients, also declined to comment. Attorneys for Galella, the Facial Beauty Institute, and Johns Dental did not respond to requests for comment on Tuesday.

The AGGA, which was recently rebranded as the Osseo-Restoration Appliance, uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. Galella has said pressure from the device causes an adult’s jaw to “remodel” forward, which he described, in training footage produced in discovery in an AGGA lawsuit, as the key to possibly “curing” patients and making them more beautiful.

“You can sell good health. You can help people and at the same time you’re going to make a wheelbarrow full of money,” Galella tells dentists in the video footage. “And it’s all OK, and it’s all fair. We’re not cheating anybody and we’re not being greedy, but that just comes with the territory.”

The KFF Health News-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device — plus attorneys who said they represent or have represented at least 23 others — and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation also found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices. Galella has said in a sworn court deposition that the device was never submitted to the FDA, which he believes wouldn’t have jurisdiction over it.

The FDA announced late last month that it is “evaluating safety concerns” about the AGGA and other similar devices.

Galella has declined to be interviewed by KFF Health News and CBS News. His attorney, Alan Fumuso, previously said in a written statement that the AGGA, “when properly used, is safe and can achieve beneficial results.”

All the AGGA lawsuits are ongoing. Galella and the other defendants have denied liability in court filings.

The plaintiffs do not allege in their lawsuits that Galella treated them but allege he or his company consulted with each of their dentists about their AGGA treatment.

CBS News producer Nicole Keller contributed to this article.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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A passenger who was trained as a wilderness first responder, Seth Coley, jumped into action and found the woman was unresponsive and had a weak pulse. Coley dug through the plane’s medical kit but couldn’t find an oropharyngeal airway, a tool that was supposed to be there and that he needed to help the woman breathe. Instead, he cleared the airway by manipulating her neck.

Afterward, Coley sent a message to Denver-based Frontier Airlines via an online customer service form: “I saved somebody’s life on one of your flights,” he wrote. “I would like to speak about the medical kit you guys have on your flights. You are missing some very valuable and simple things. She almost died.”

Americans are flying at levels reaching pre-pandemic numbers. While covid-19 ushered in new health and cleaning protocols designed to make airplane travel safer, incidents like Coley’s raise questions about airlines’ readiness for medical emergencies because of incomplete or insufficient medical kits and the training of flight crews, who often rely on other passengers in emergencies.

Frontier did not respond to KHN’s requests for comment about that incident or its emergency kits. But Coley’s experience illustrates the risks travelers take every time they board a flight. For every 20,000 passengers who take a flight on a U.S.-based airline, there is one medical event — defined as any health-related incident, not only emergencies — according to estimates from airplane medical services company MedAire.

The Federal Aviation Administration requires commercial aircraft to carry at least one sealed emergency medical kit containing a minimum of 25 specified instruments and medications, plus first-aid kits and automated external defibrillators. But the FAA does not track data on the use of those kits during in-flight medical emergencies. Instead, the agency leaves it to the airlines to inspect the kits and replace them if the seals are broken.

“Ensuring complete, sealed emergency medical kits are present is part of the cabin crew’s preflight inspection,” FAA spokesperson Ian Gregor said in a statement.

But, as Coley and other passengers who have responded to an in-flight emergency have found out, an item required in a medical kit can sometimes be missing. Some items the FAA doesn’t require, such as the overdose reversal drug naloxone, are carried voluntarily by some airlines. The agency has issued guidance recommending items to add to the kits, but they are not yet mandated.

Gregor said the FAA investigates all reports of issues with medical kits and ensures any concerns are addressed. He did not respond to a KHN request for details on the number of reports investigated, their outcomes, or whether the emergencies described in this article were among those investigated.

In June, Boston surgeon Dr. Andrea Merrill was aboard a Delta Air Lines flight when she assisted in a medical emergency and found the kit fell short of what she needed.

It needs “a glucometer, epi pen, and automatic blood pressure cuffs — it’s impossible to hear with a disposable stethoscope in the air,” Merrill tweeted to Delta after the incident. “Please improve this for passenger safety!”

After Merrill’s tweet went viral, Delta followed up with her, saying it would switch to automatic blood pressure cuffs and “real” stethoscopes, as well as consider glucometers at gates. Merrill declined an interview request.

KHN asked U.S. airlines to detail their medical emergency protocols and the contents of their medical kits. Seven responded with limited information: Alaska, Allegiant, Hawaiian, JetBlue, Southwest, Sun Country, and United. All said that their kits meet or exceed FAA requirements and that they train their staff to respond to medical emergencies. Many airlines also contract with a MedAire service called MedLink that connects flight crews with a medical professional on the ground in an in-flight emergency.

Allegiant officials said passengers with medical conditions should not assume their planes will have everything they need in an emergency. “Although our crews are trained to respond to a wide array of unplanned medical emergencies, we want to remind readers who have anticipated medical needs to bring their own medical supplies in carry-on luggage and not rely on aircraft emergency equipment,” Allegiant spokesperson Andrew Porrello said in a statement.

Delta, along with American, Frontier, and Spirit, did not respond to requests for comment. A 2019 article on the Delta website said its flight attendants are given training in first aid and CPR. Additionally, Delta wrote that its medical equipment exceeds FAA requirements. The airline mentioned it uses STAT-MD, a service that lets flight crews consult with trained personnel at the University of Pittsburgh Medical Center.

The FAA requires flight attendants to receive specific medical training, but medical professionals who have intervened as passengers during an in-flight emergency said the crew is not always quick to respond.

“Passengers believe that there are probably more safeguards in place than there actually are,” said Dr. Comilla Sasson, a Denver-area emergency physician and associate clinical professor at the University of Colorado.

Sasson was on a United Airlines flight in 2018 when a passenger passed out. When she volunteered to help, crew members asked for proof that she was a doctor as she mobilized to check the passenger’s vital signs. Sasson questioned the extent to which crew members are trained to help in medical emergencies, saying other health care providers have told her about their own experiences of aiding a passenger in need while the flight personnel stood aside.

“It’s interesting to me that the airlines really kind of depend on the kindness of strangers in a lot of ways, much more so than I would think,” Sasson said.

The goodwill of a fellow passenger is something Bay Area resident Meera Mani is thankful for after a 2011 experience. She was on a United flight from Toronto to San Francisco when her now-deceased father, then in his 80s, began showing concerning symptoms: The right side of his face and arm drooped. Worried her dad was having a stroke, Mani shouted for help but was frustrated by flight attendants’ slow response.

“And then finally, I said: ‘Is there a doctor on the flight?’” Mani recounted.

There was. The doctor used a defibrillator to stabilize her father.

“It was very clear to me that the [flight] staff were completely flummoxed,” Mani said. “They had the equipment, they took it out, they gave it to him, but the doctor took care of it.”

United helped organize an ambulance to meet Mani and her father on the ground at the San Francisco airport and later called to see if her dad was OK. He ended up being diagnosed with a condition that could lead to fainting.

MedAire, which runs the MedLink consulting service, said it covers around 70% of the U.S. market but declined to specify airlines. Dr. Paulo Alves, MedAire’s global medical director of aviation health, said 98% of medical events are managed on board and are non-life-threatening, while 2% are serious cases that might divert a flight.

Alves said his company also provides medical consultations before passengers board a flight.

“An airplane — although I love aviation — is never the best place for you to have a medical event,” Alves said. “The first line of prevention is actually preflight.”

Alves also defended the contents of airlines’ medical kits. The medically trained volunteers who step in to help fellow passengers in an emergency may expect resources available in a hospital, but “the airplane is not a hospital. You cannot carry everything,” he said.

Mani said she would like to see airlines disclose which medical emergencies they’re trained to address — potentially on flight safety cards. Sasson said it would be helpful if airlines clearly shared information about what medical supplies are available on board.

“I think the general public doesn’t realize how much of a crapshoot it is when they’re up in the air that somebody with some sort of medical training will know what to do, if something were to happen,” Sasson said.

This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Full recovery is expected to take a year or more for Perkinson.

“If it wasn’t for the ECMO and the doctors that were put in place at the right time with the right knowledge, I would not be here,” he said, with his wife, Kacie, by his side.

“Could there have been a miracle and he could have lived if he hadn’t gotten [ECMO]? Maybe. But the chances were absolutely slim to none,” Kacie said.

A new study from Vanderbilt shows she’s probably right about those chances.

During the surge of the delta variant of covid-19 late last summer, ECMO therapy was in short supply across the South. Vanderbilt’s unit was taking 10 to 15 calls a day from hospitals without ECMO looking for an open bed. Even patients’ families were calling on behalf of dying loved ones.

“‘There’s no beds. There’s no nurses. There’s no machines. There’s just not enough. We just physically can’t,’” nurse practitioner Whitney Gannon said she would tell people calling from hospitals around the South. “It’s the worst feeling in the world.”

But Gannon grew curious about what happened to the patients she had to turn down — especially those who were young and healthy, like Perkinson, who was 28. She started checking back, informally.

Many of them had died, including a pregnant woman.

So, within a matter of weeks, she helped launch an official study. And Gannon’s team started taking every call, even when no beds were available.

“We wanted to know: Is this patient truly medically eligible for ECMO? Would we provide ECMO? And if we didn’t, we wanted to know what happened to that patient,” Gannon said.

The results, published in the American Journal of Respiratory and Critical Care Medicine, are grim. Nearly 90% who couldn’t find a spot at an ECMO center died. And these patients were under 60 and previously healthy, with a median age of 40.

Over the course of the pandemic, hospitals have had difficulty deciding who gets priority when ECMO, which stands for extracorporeal membrane oxygenation, is in short supply. It’s not an exact science. And there are precious few ECMO beds, especially when some patients linger for months on the machine, only to die.

Perkinson was a good candidate since he’s young and — before falling ill with covid — relatively healthy. A machinist from Greenbrier, Tennessee, and a father of two, he caught covid after making an appointment to get his first dose of vaccine, he said.

Without vaccine protection, he didn’t fare well against the virus. He was put on a ventilator just after Christmas and within days stepped up to an available ECMO bed as his blood oxygen levels dropped.

For nearly two months, his blood flowed through a tube in his neck to the ECMO unit, which infused it with oxygen, took out the carbon dioxide, and sent it back into his body. He was sedated the entire time, increasing his risk of long-term organ damage and disability.

The use of ECMO spiked during the pandemic. Never has it been used so widely, but the data remains limited. And a study published in The Lancet in September 2021 found that the number of covid patients dying while on ECMO had increased 15% since the beginning of the pandemic.

Even early on, only half were surviving. And as the pandemic dragged on, more hospitals with less experience were using ECMO, and some expanded criteria to include older patients or those with risk factors like obesity who do not do as well.

Hospital capacity crunches have been central to the debate because ECMO requires a small village of nurses and respiratory therapists. And sometimes the patients stay on the therapy for months, not just weeks.

One patient currently at Vanderbilt, which has just seven ECMO beds, has been there since last year’s delta surge, said Dr. Jonathan Casey.

“So you can imagine how it doesn’t take much to fill this resource even during a small wave,” Casey said.

Even during the omicron surge, Casey said, Vanderbilt has turned down some transfer requests for ECMO.

While the odds of survival with critical covid patients are still roughly 50-50, the Vanderbilt study shows what happens if the therapy is unavailable.

“I’m trying to convince people that this is a resource worth investing in and then hoping people invest in those resources over time,” said Casey, the study’s senior author.

Until there is broader access to ECMO, Casey said, the country also needs to find a better way to decide who is prioritized for treatment, similar to how organ transplant allocation works. There is a national ECMO organization called the Extracorporeal Life Support Organization, but it doesn’t get involved with triaging patients yet.

Some hospitals will agree to try ECMO on someone over 70, if the family pushes hard enough. Others turn down patients over 50, especially if they have underlying diabetes or heart disease.

Small-scale cooperative efforts are underway. In Minnesota, hospitals have agreed to use the same strict patient criteria and a statewide referral process.

The decisions are still “ethically nuanced,” said Dr. Matthew Prekker, who helped set up the consortium before the pandemic emerged. Cooperation could mean giving an ECMO bed to a patient from across the state instead of someone in your own hospital.

The goal is simply for more patients to survive.

“It takes a lot of cooperation among health systems and state leadership,” he said. “But I think doctors and communities have more appetite for that now than they did before.”

This story is part of a partnership that includes WPLN, NPR, and KHN.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Four years later, federal regulators have yet to issue rules to implement the law. But changes in the industry are offering consumers relief.

In August 2017, President Donald Trump signed the legislation that called for the Food and Drug Administration to issue regulations by 2020 for hearing aids that could be sold in stores without a prescription or a visit to an audiologist or other hearing specialist. That hasn’t happened yet, and President Joe Biden last month ordered the FDA to produce those rules for over-the-counter (OTC) purchases by mid-November. That means it will likely take at least until next summer for consumers to feel the direct effects of the law.

Despite the delay, consumers’ options have expanded with more hearing devices entering the market, alternative ways to get them and lower prices, particularly for the largest segment of the population with impaired hearing — those with mild to moderate hearing loss, for whom the law was intended.

Leading consumer brands Apple and Bose are offering products and several smaller companies sell aids directly to consumers, providing hearing tests and customer service online from audiologists and other hearing specialists. Even major retailers offer hearing aids directly to consumers and provide audiology services online: Walgreens stores in five Southern and Western states sell what the chain calls “FDA-registered” Lexie hearing aids for $799 a pair — far less than half the price of typical devices.

Nationally, personal sound amplification products, or PSAPs, that are smaller and customizable are now available in stores and online. These devices, which look like hearing aids and sell for a fraction of the price, amplify sounds, but some do not address other components of hearing loss, such as distortion.

“There are many more options than there were in 2017 when Trump signed the Hearing Aid Act into law,” said Nancy Williams, president of Auditory Insight, a hearing industry consulting firm in New Haven, Connecticut. “In a sense, you can say the OTC revolution is happening without the FDA, but the difficulty is it is happening more slowly than if the FDA issued its rules on time.”

The price for a pair of standard hearing aids typically ranges from $2,000 to $8,000, depending on the technology. That price includes the professional fitting fees and follow-up visits. The hearing aid industry has remained largely insulated from price competition because of consolidation among manufacturers, widespread state licensing laws that mandate sales through audiologists or other hearing professionals, and the acquisition of hearing professionals’ practices by device makers.

The federal law creates a category of hearing aids that would legally bypass state dispensing laws and enable consumers to buy aids in stores without consulting a hearing aid professional. Users would be expected to program the devices through a smartphone, and companies could offer service via phone or internet.

With an increasing number of hearing aids and PSAPs being sold directly to consumers, advocates are eager for the FDA rules to come out, because they worry about the confusion caused by the array of choices — with none having the FDA’s full seal of approval.

“The FDA delaying regulations has done more harm than good, because the direct-to-consumer market is filling the void and people are doing what they want, and we don’t know the quality of these devices,” said Barbara Kelley, executive director of the Hearing Loss Association of America, a consumer advocacy group.

The law, sponsored by Sen. Elizabeth Warren (D-Mass.), gave the FDA until August 2020 to issue regulations. Last year, after missing that deadline, FDA officials said the covid-19 pandemic had delayed the rule-making process.

Many in the hearing aid industry are concerned about the unchecked competition likely to come with allowing consumers to buy aids on their own without an evaluation by a hearing specialist.

Brandon Sawalich, CEO of Starkey, the largest U.S.-based hearing aid company, said consumers need expert assistance to test their hearing, buy an appropriate aid, properly fit it and fine-tune its settings.

“It’s not just picking up something off the shelf at your local drugstore or ordering something online and putting it in your ear and your life is going to be reconnected and you are going to hear perfectly again,” he said on a recent podcast. “It doesn’t work that way, and it’s not that easy.”

However, by avoiding professional help, more Americans likely can get hearing assistance. “The OTC and direct-to-consumer options open up avenues for those who have no other path to get hearing aids,” said Hope Lanter, a Charlotte, North Carolina, audiologist with Hear.com, a Netherlands-based online hearing aid retailer.

She expects that after the FDA issues its rules many hearing aid manufacturers will develop lower-cost, over-the-counter devices that can be obtained without an audiologist’s evaluation. She said consumers with modest hearing loss may start out with those types of aids, but later, if their hearing worsens, shift to more expensive devices that require assistance from hearing aid professionals.

“In my view, there is enough pie for everyone,” Lanter said, noting that millions of people with hearing loss are not getting any help today. More than 37 million American adults have trouble hearing, including nearly half of people over age 60. Only 1 in 4 adults who could benefit from a hearing aid have ever used one, federal health officials estimate.

Unlike most consumer electronics, hearing aids have remained expensive for decades, generating consumer complaints.

The price is concerning because Medicare and many insurers don’t cover hearing aids, though most private Medicare Advantage plans do. Only about half of state Medicaid programs cover the devices, but benefits in those states vary widely, according to data from KFF.

Industry experts predict new over-the-counter hearing aids will be priced at less than $1,000 a pair — about 25% lower than low-cost retailer Costco sells its Kirkland aids, dispensed through a hearing aid professional.

Without federal rules in place, manufacturers have largely waited to develop devices for the OTC market.

Bose chose a different path. This spring it began selling its hearing aids, which can be purchased online without a doctor visit, hearing test or prescription. Bose gained FDA clearance in 2018 after providing data showing the effectiveness of its self-fitting aids was comparable to similar devices fitted by a hearing professional. The Bose aids sell for $849 a pair.

Meanwhile, Apple last year integrated hearing assistance into its popular Air Pods Pro earbuds, which can be customized using settings on an iPhone. Apple is not marketing the free benefit as a hearing aid but instead as similar to a PSAP that amplifies sound to help hearing.

Several companies such as Eargo, Lively and Lexie allow consumers to buy aids online and get help from specialists to set them up remotely. As long as companies have generous return policies that enable people to try a couple of aids to see which works best, the proliferation of online options selling high-quality aids is good news for consumers, said Williams, the Connecticut hearing consultant.

Lanter said the stigma around hearing aids will be reduced as people obtain them more easily. She predicted consumers will someday buy hearing aids much as they can buy inexpensive reading eyeglasses at the drugstore today with the option to get a prescription for higher-quality glasses or ones with a more precise fit.

Michelle Arnold, an audiologist and assistant professor at the University of South Florida, said there is no evidence consumers will be harmed buying a hearing aid without seeing an audiologist, and the benefits of getting some improvement in their hearing outweigh any risks. “Will people get the maximum benefit? Maybe not, but it’s better than nothing,” she said.

This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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And then, just over a year after the ordeal, she read a Kaiser Health News investigation that described worse cases. KHN revealed that the Food and Drug Administration had allowed stapler maker Covidien to quietly file tens of thousands of reports of stapler malfunctions into a then-hidden database.

Alarmed that others had been harmed and reports had been hidden, Bonner, a retired Oakland, Calif., doctor, decided to go forward with a lawsuit against the stapler maker.

“If the information had been out there, then maybe Covidien would have changed the design of the staplers and made them safer,” she said, “and that would have obviated the problem in the first place.”

Bonner’s lawsuit is one example of how a vast cache of records that were released this summer are taking on a life of their own.

For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials knew existed.

In 2016, for example, Covidien reported 84 injuries or malfunctions in the public database known as MAUDE, while nearly 10,000 incidents flowed into the hidden database, KHN reported in March. A few MAUDE reports mentioned the existence of an “alternative summary reporting” program, but until this summer, the FDA made that internal data available only through the Freedom of Information process, which can take up to two years.

KHN’s investigation prompted then-FDA commissioner Scott Gottlieb to pledge in a tweet to open the hidden data to the public. The agency released all 5.7 million records in June.

Since then, researchers, lawyers and the FDA’s own officials have taken a closer look at the data to learn more about which devices malfunctioned, and how often.

Libbe Englander, the founder and CEO of Pharm3r, a medical data consulting firm, discovered that the devices in the hidden database were much riskier than other devices tracked by the FDA.

Her firm concluded that the hidden reports were “more likely to be associated with life-threatening devices and to contain potentially serious problems.”

For example, just 10% of the devices tracked in the MAUDE database are implanted in the body. But 44% of those in the hidden data are lodged in a patient’s body, including pacemakers and heart valves.

The Pharm3r report also found that the devices in the hidden data were more likely to be subject to a Class 1 recall, initiated when a device problem could cause serious injury or death. The report also underscored how vast the now-open data is ― accounting for about 40% of the total device-problem reports lodged with the FDA over the past two decades.

The once-hidden reports also figured into the ECRI Institute’s annual list of health technology hazards, a list circulated to hospitals and health systems.

ECRI found that this year’s No. 1 hazard was misuse of the surgical stapler ― which has been linked to 412 deaths, more than 11,000 serious injuries and nearly 100,000 malfunctions since 2011, according to the FDA.

“Most of these [stapler] reports had not previously been accessible to the public,” the ECRI report notes. ECRI has advised doctors to have a backup plan in place in case a stapler malfunctions during surgery.

“If a hazard is getting a lot of attention, hospitals want to have a plan to address that,” said Rob Schluth, a senior project officer with the institute.

For Bonner, the problems with a surgical stapler became apparent just over a week after she had colon surgery in November 2017. Retired from a career as a hospital physician, she knew the steps to take toward recovery. But she felt nauseated all the time and could barely hold down water.

“I was trying to get up and walk,” she said. “I was doing everything, but I just got worse and worse.”

Doctors went in for a second surgery on Dec. 6 and found infected pus filling her abdomen. They routed her colon’s contents to be collected outside her body. It took additional surgeries to restore her colon function and address hernias caused by the procedures.

Bonner’s lawsuit alleges that a Covidien stapler caused her bowel leak and that the company, by not reporting malfunctions to the public database for years, “have hidden the true risks of using the device from surgeons and patients.”

In court records filed in the ongoing case, Covidien denied all of Bonner’s claims but did say that the FDA invited the company in 2001 to submit stapler malfunctions with quarterly “alternative summary” reports.

Medtronic spokesman John Jordan said the company does not have a comment on the pending legal case.

Other devices are under scrutiny. The once-hidden data showed more than 2 million problems with dental implants.

During an October FDA webinar on dental devices, an FDA official said her office was “taking a deeper dive and trying to identify lessons learned” from dental implant incidents.

Dr. Malvina Eydelman, of the Division of Dental Devices in the agency’s device branch, acknowledged that the number of events was “very high” and said her team was trying to develop a plan to share information with the public.

Also under scrutiny are the textured breast implants made by Allergan. The company’s Biocell implants, recalled in July, have been linked to 12 deaths and 481 of the 573 worldwide cases of “breast implant-associated” lymphoma, according to the FDA. Breast implant injuries and malfunctions accounted for nearly half a million reports in the hidden database, including implants that leaked, deflated or migrated.

Patients in Missouri, California, New York and Illinois have filed federal class action lawsuits against Allergan in recent weeks, each decrying the company’s heavy use of the “alternative summary reporting” program to file injury reports ― which were analyzed by the International Consortium of Investigative Journalists.

A class action case filed in Florida notes FDA rules say that alternative summary reports cannot include severe or unexpected events, “yet it is believed that these incidents were kept hidden in ASRs,” including at least one lymphoma case.

An ongoing federal securities lawsuit also alleges that Allergan used “inappropriately nonpublic” alternative summary reports, disregarding the “risk that some [lymphoma] cases would go undetected by the FDA.”

Allergan has not yet responded to the class action cases or to calls for comment. It denied the “threadbare” allegation in the securities lawsuit, citing the KHN article, which “makes clear that the filing of ASRs was permissible and even encouraged by the FDA to reduce ‘redundant paperwork.’”

While the FDA has ended the alternative summary reporting program, it opened the door for makers of more than 5,000 device types to file quarterly summaries of reported malfunctions. In each case, the device maker must file a public report to the MAUDE database noting how many reports were filed directly with the agency.

An FDA spokeswoman said the agency has stopped accepting summary reports of injuries cited in pelvic mesh lawsuits. The agency does continue to accept hundreds of death report summaries under a special exemption for devices tracked in a “registry” held by a specialty medical society.

“We are in the process of reviewing the effects of these changes and will continue working to improve the usability and transparency of information in the MAUDE database — whether that information was submitted as a summary or individual report,” FDA spokeswoman Stephanie Caccomo said in an email.

The release has not been as informative as Madris Tomes had hoped, she said, given that the FDA did not disclose data on how the devices harmed patients. Tomes is a former FDA manager who runs the company Device Events, which analyzes FDA data.

For instance, she said a breast implant injury report might say there was a “biocompatibility” problem, but it’s unclear what happened to the patient.

“Did it result in lymphoma or the patient needing a device replacement?” asked Tomes. “Without that outcome, we’re still a little bit in the dark on what this data means.”

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Un hospital de Illinois sorteó boletos para un dispositivo inteligente con el fin de atraer a personas para que un cirujano revisara sus abdómenes; otro en Indiana ofreció la oportunidad de ganar una cena en un restaurante de carnes.

Los anuncios de eventos de detección en Colorado y Maryland advertían sobre complicaciones “potencialmente mortales” que podrían surgir si las hernias no se tratan. Y hospitales en Georgia y California incluyeron la oportunidad de “probar” un robot quirúrgico.

Los hospitales dicen que estos exámenes brindan una educación valiosa sobre las opciones de tratamiento para una afección médica común, en la que parte del intestino sobresale a través de un punto frágil de la pared abdominal.

Pero no se ha realizado ninguna investigación sobre las pruebas de detección de hernias, y algunos expertos temen que estos esfuerzos de divulgación, algunos de los cuales muestran dispositivos de cirugía robótica da Vinci fabricados por Intuitive Surgical, con sede en Sunnyvale, California, podrían llevar a las personas a someterse a cirugías potencialmente dañinas que no hacen no necesitan.

“Mi pregunta es: ¿por qué estamos haciendo esto?”, dijo la doctora Dana Telem, profesora asociada de la Escuela de Medicina de la Universidad de Michigan y directora del Programa Integral de Hernia de Michigan Medicine. “Incluso con la mejor intención, me preocupa las consecuencias no deseadas en el futuro”.

Una condición común

Según los Centros para el Control y Prevención de Enfermedades (CDC), en el país se diagnostican aproximadamente 1,6 millones de hernias en la ingle; y se tratan quirúrgicamente 500,000 al año. Se espera que alrededor del 27% de los hombres y el 3% de las mujeres tengan una hernia inguinal, el tipo más común, en algún momento de sus vidas.

Las hernias pueden causar dolor y protuberancias anormales, y muchos pacientes finalmente optan por repararlas con cirugía. La cirugía también puede prevenir una condición rara pero grave llamada estrangulación, en la cual una hernia puede enrollarse en el intestino y cortar el flujo sanguíneo, lo que requiere una intervención de emergencia.

Sin embargo, las complicaciones de la cirugía de hernia son comunes. Si bien cualquier cirugía conlleva riesgos, como una infección, las reparaciones de hernia en la ingle dejan hasta a 12% de los pacientes con dolor crónico que puede ser debilitante, según un estudio de 2016.

También hay evidencia sólida de que las personas que tienen pocos síntomas pueden optar de forma segura por monitorear la hernia, sin necesidad de pasar por el quirófano, según un artículo de 2018 publicado en JAMA. Pero esta información a menudo falta en los anuncios de detección hospitalaria.

De hecho, expertos, incluido el American College of Surgeons, dicen que no hay datos que respalden el uso de exámenes de hernia.

“¿Una prueba de detección de hernia? Para mí no tiene sentido”, dijo el doctor Michael Rosen, director del Centro de Hernia de la Clínica Cleveland y director médico de Americas Hernia Society Quality Collaborative, un consorcio que monitorea los resultados de los tratamientos. “Obviamente, está ahí para llevar a las personas a los quirófanos”.

Promoción de la cirugía robótica

Algunos hospitales dicen que las advertencias sobre los riesgos de no tratar las hernias son apropiadas, y estos eventos educan al público, mitigan los temores sobre la cirugía robótica y ofrecen atención a personas que de otro modo no podrían o no verían a un médico. Varios hospitales dijeron que sus médicos informan a los pacientes sobre todas las opciones de tratamiento, no solo sobre la cirugía robótica.

“Desafortunadamente, puedes hacer que las personas entren por la palabra ‘gratis'”, dijo Victoria Montei, directora de servicios quirúrgicos del sistema MidMichigan Health, con sede en Midland, que ha organizado dos eventos de detección de hernia que atrajeron a 52 personas, en donde se detectaron 33 hernias. “Para muchas personas, un copago de $20, $50, $100 [para ver a un médico] puede ser mucho. Lo posponen”.

Algunos hospitales también utilizan pruebas de hernia para mostrar sus llamativos robots quirúrgicos da Vinci, muchas veces argumentando que las imágenes 3D y los movimientos precisos de los robots reducen el dolor y las complicaciones, y aceleran los tiempos de recuperación.

Northeast Georgia Health System, en Gainesville, recientemente exhibió uno de sus cuatro dispositivos da Vinci durante tres días, en un evento de detección de hernia y en encuentros comunitarios. Ver de cerca el da Vinci “ayuda a explicar al paciente el valor que tiene”, dijo Kristin Grace, vocera del Sistema de Salud.

Sin embargo, algunos hospitales parecen repensar sus estrategias. El doctor Sari Nabulsi, director médico del Hospital del Centro Médico en Odessa, Texas, que organizó un evento de detección de hernia en 2018, dijo por correo electrónico que el hospital “no promueve la detección de hernia ya que no hay valor clínico para tales pruebas”. Su evento de 2018 fue para “concientizar”, y el hospital “no anticipa repetir el evento en 2019 “, agregó.

Ben Drew, vocero de John Muir Health, con sede en Walnut Creek, California, que anunció una prueba de manejo de robot como parte de un evento de detección de hernia, dijo en un correo electrónico que el robot “no era el foco de la evaluación o la información proporcionada a los pacientes”, y que su anuncio “podría haberse redactado más claramente”.

Resultados que no son claros

El robot se ha comercializado como una forma para que los cirujanos agreguen una cirugía mínimamente invasiva a sus kits de herramientas. La mayoría de las hernias se reparan mediante cirugías abiertas, que requieren de cortes grandes. La cirugía laparoscópica convencional, con cortes más pequeños, es técnicamente difícil de aprender para la reparación de la hernia, dijo Rosen.

Pero expertos dicen que no hay evidencia firme de que la cirugía robótica proporcione mejores resultados.

De hecho, la cirugía robótica a veces se ha adoptado antes de tener evidencia de que ofrece un beneficio. Las reclamaciones no se han utilizado para las histerectomías, y la Administración de Alimentos y Medicamentos (FDA) ha emitido un aviso de seguridad sobre el uso de robots en cirugías de cáncer.

Rosen dijo que este otoño se espera la publicación de un estudio piloto que dirige, que compara la reparación de la hernia robótica con la cirugía laparoscópica convencional.

El ensayo comparará los dos enfoques sobre el dolor informado por el paciente, el costo, la ergonomía para los cirujanos y las tasas de recurrencia a largo plazo. Aun así, se necesitarán estudios más grandes para guiar la práctica clínica, dejando respuestas concretas a años de distancia, dijo Rosen.

Sin embargo, el fabricante de da Vinci, Intuitive Surgical, ha seguido adelante con los esfuerzos para promover su uso para la reparación de hernias. En un correo electrónico, confirmó que ha proporcionado robots de demostración e “información educativa” para los exámenes de detección de hernias a pedido de cirujanos y hospitales.

La compañía dijo que la información que proporciona para los eventos de detección incluye “descripciones de las opciones quirúrgicas y no quirúrgicas para la reparación de la hernia, incluidos los riesgos y beneficios asociados”, y espera que “una gran parte de las reparaciones de hernias continúe realizándose a través de diferentes procedimientos quirúrgicos modalidades”. En otras palabras, la forma en que tradicionalmente se han hecho.

El informe anual de 2018 de Intuitive identificó la reparación de hernias como una oportunidad de crecimiento “significativa”, con cirugías generales, incluida la reparación de hernias, que se convirtió en la categoría más grande de procedimientos en el país en 2018. La compañía reportó ingresos netos de $1.100 millones en 2018, frente a $ 671 millones en 2017.

La economía de la cirugía robótica

La cirugía general es uno de los pilares de los hospitales comunitarios, que recientemente han comenzado a invertir en sistemas robóticos como una forma de promocionarse como “la última tecnología”, dijo Diane Robertson, directora de evaluación de tecnología de salud en el Instituto ECRI, una organización sin fines de lucro que estudia la seguridad y la rentabilidad de las intervenciones médicas.

Pero ECRI escribió una advertencia de que la rápida adopción de sistemas robóticos por parte de los hospitales ha superado el desarrollo de estándares de capacitación y acreditación para los cirujanos que los usan.

Puede que los hospitales no piensen si es lo mejor para el paciente o la opción más rentable, agregó Robertson. Dijo que, en el caso de las reparaciones de hernias “la pregunta es por qué tendrías que hacerlas robóticamente”.

Cada da Vinci cuesta un promedio de $1.5 millones, más cientos de miles de dólares anuales para mantenerlo y equiparlo, según el informe anual de Intuitive.

Intuitive anuncia en un video en su sitio web que los sistemas robóticos ayudan a los hospitales a atraer a los cirujanos y ganar cuota de mercado. Agrega que los programas robóticos pueden ayudar a los hospitales a ser “más eficientes y rentables”.

Pero las cirugías robóticas cuestan más a los hospitales y, a menudo, las aseguradoras reembolsan a la misma tasa que la laparoscopia convencional, según algunos expertos. Una revisión de 510 reparaciones de hernia en la Universidad de Virginia halló que el costo promedio del hospital de una reparación de hernia robótica era de $7,162, frente a $4,527 para procedimientos laparoscópicos y $4,264 para cirugías abiertas.

Aunque los pacientes individuales pueden no pagar necesariamente más por una cirugía robótica, dijo Robertson, la tecnología contribuye a un mayor gasto general en atención médica y puede desviar recursos de otras prioridades. Además, Medicare, financiado por los contribuyentes, puede terminar reembolsando a los hospitales indirectamente por cirugías robóticas.

Para al menos un hospital, la cirugía robótica no valió la pena.

El Hospital Massena Memorial de 50 camas en el estado de Nueva York finalizó sus servicios robóticos en junio para ayudar a reducir un déficit operativo, según Patrick Facteau, su director financiero.

El da Vinci no aumentó el volumen quirúrgico del hospital a pesar de un impulso de comercialización que incluyó exámenes de hernia mensuales gratuitos, dijo Facteau.

“Parte del argumento de venta es que obtendrá más cirugías y reducirá los costos”, dijo. “Realmente no vimos eso”.

Dijo que el da Vinci tampoco mejoró las medidas de calidad quirúrgica del hospital ni redujo la duración de la estadía. La mayoría de los procedimientos de hernia ya se realizan de forma ambulatoria.

El hospital, en la ciudad de Massena de 12,000 personas, justo al sur del río San Lorenzo, estaba pagando alrededor de $500,000 al año para alquilar un da Vinci y cubrir el mantenimiento y los instrumentos, dijo.

A diferencia de la mayoría de los hospitales, que compraron sus sistemas, Massena tuvo la flexibilidad de anular su contrato.

Esta historia fue producida por Kaiser Health News, un programa editorial independiente de la Kaiser Family Foundation.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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One Illinois hospital raffled off tickets for a smart speaker to entice people to get their abdomens checked by a surgeon, while an Indiana hospital offered a chance to win dinner at a chophouse.

Announcements for screening events in Colorado and Maryland warned about “life-threatening” complications that could arise if hernias are left untreated. And hospitals in Georgia and California included a chance to “test-drive” a surgical robot.

Hospitals say such screenings provide valuable education about treatment options for the common medical condition, in which part of the intestine protrudes through a weak spot in the abdominal wall.

But no research has been done on hernia screenings, and some experts worry that these outreach efforts — some of which showcase da Vinci robotic surgery devices made by Intuitive Surgical based in Sunnyvale, Calif. — could lead people to get potentially harmful operations they don’t need.

“My question is: Why are we doing this?” said University of Michigan Medical School associate professor Dr. Dana Telem, the director of Michigan Medicine’s Comprehensive Hernia Program. “Even with the best intent, it makes me worry about the unintended consequences down the line.”

A Common Condition

An estimated 1.6 million groin hernias are diagnosed and 500,000 are surgically repaired annually in the U.S., according to the Centers for Disease Control and Prevention. Some 27% of men and 3% of women are expected to have a groin hernia — the most common type — during their lifetimes.

Hernias can cause pain and abnormal bulges, and many patients eventually opt to get them fixed with surgery. Surgery can also prevent a rare but serious condition called strangulation, in which a hernia can entrap the intestine and cut off blood flow, requiring emergency surgery.

However, complications from hernia surgery are common. While any surgery carries risks, such as infection, groin hernia repairs leave as many as 12% of patients with chronic pain that can be debilitating, according to a 2016 study.

There’s also good evidence that people who have few symptoms can safely opt for watchful waiting rather than go under the knife, according to a 2018 article in JAMA. But such cautionary information is often missing in hospital screening announcements.

In fact, experts, including the American College of Surgeons, say there’s no data to back the use of such hernia screenings.

“A screening for hernia? That makes no sense to me,” said Dr. Michael Rosen, director of the Cleveland Clinic’s Hernia Center and medical director of the Americas Hernia Society Quality Collaborative, a consortium that tracks treatment outcomes. “Obviously, it’s just there to drive people to the operating room.”

Promoting Robotic Surgery

Some hospitals say warnings about the risks of letting hernias go untreated are appropriate, and these events educate the public, quell fears about robotic surgery and serve people who otherwise can’t or won’t see a doctor. Several hospitals said their doctors inform patients about all treatment options, not just robotic surgery.

“Unfortunately, you can get people in the door for their own protection with the word ‘free,’” said Victoria Montei, system director of surgical services at Midland-based MidMichigan Health system, which has hosted two hernia screening events that attracted 52 people and detected 33 hernias. “For a lot of people, a $20, $50, $100 copay [to see a doctor] can be a lot. They put it off.”

Some hospitals also use hernia screening to show off their flashy da Vinci surgical robots, often claiming that the robots’ 3D imaging and precision movements lead to reduced pain, fewer complications and faster recovery times.

Northeast Georgia Health System in Gainesville recently took one of its four da Vinci devices out of commission for three days to demo it at a hernia screening and other community events. Seeing the da Vinci up close “helps explain to the patient the value of it,” said Health System spokeswoman Kristin Grace.

Yet some hospitals seem to be rethinking their strategies. Dr. Sari Nabulsi, the chief medical officer of Medical Center Hospital in Odessa, Texas, which hosted a hernia screening event in 2018, said via email that the hospital “does not promote screening for hernia as there is no clinical value to such tests.” Its 2018 event was for “awareness” and the hospital “does not anticipate repeating the event in 2019,” he added.

Ben Drew, a spokesman for Walnut Creek, Calif.,-based John Muir Health, which advertised a robot test drive as part of a hernia screening event, said in an email that the robot was “not the focus of the assessment or the information provided to patients” and its announcement “could have been worded more clearly.”

Unclear Outcomes

The robot has been marketed as a way for surgeons to add minimally invasive surgery to their toolkits. Most hernias are repaired by open surgery, which uses large cuts. Conventional laparoscopic surgery, which uses smaller cuts, is technically challenging to learn for hernia repair, Rosen said.

But experts say there’s no firm evidence that robotic surgery provides better outcomes for hernia repair.

In fact, robotic surgery has sometimes been adopted ahead of evidence that it offers a benefit. Claims haven’t panned out for hysterectomies, and the Food and Drug Administration has issued a safety notice about the use of robots in cancer surgeries.

Results of a pilot randomized clinical trial to compare robotic hernia repair with conventional laparoscopic surgery are expected to be published this fall, said Rosen, who is leading the study.

The trial will compare the two approaches on patient-reported pain, cost, ergonomics for surgeons and long-term recurrence rates. Still, larger studies will be needed to guide clinical practice, leaving answers years away, said Rosen.

Nevertheless, da Vinci’s manufacturer, Intuitive Surgical, has been pressing ahead with efforts to promote its use for hernia repair. In an email, Intuitive confirmed it has provided demo robots and “educational information” for hernia screenings at the request of surgeons and hospitals.

The company said the information it provides for screening events includes “descriptions of surgical and non-surgical options for hernia repair, including associated risks and benefits,” and it expects that “a large portion of hernia repairs will continue to be performed via different surgical modalities.” In other words, the way they’ve traditionally been done.

Intuitive’s 2018 annual report identified hernia repair as a “significant” growth opportunity, with general surgeries, including hernia repair, becoming the largest category of U.S. procedures in 2018. The company reported net income of $1.1 billion in 2018, up from $671 million in 2017.

The Economics Of Robotic Surgery

General surgery is a mainstay of community hospitals, which have recently begun to invest in robotic systems as a way to market themselves as “up on the latest technology,” said Diane Robertson, director of health technology assessment at ECRI Institute, a nonprofit that studies safety and cost-effectiveness of medical interventions.

But ECRI wrote an advisory warning that hospitals’ rapid adoption of robotic systems has outpaced the development of training and credentialing standards for the surgeons who use them.

Hospitals may not be thinking about whether it’s best for the patient or the most cost-effective option, Robertson added. For hernia repairs, she said, “There’s a huge question about why you would need to do them robotically.”

Each da Vinci costs an average of $1.5 million, plus hundreds of thousands of dollars annually to maintain and equip, according to Intuitive’s annual report.

Intuitive advertises in a video on its website that the robotic systems help hospitals woo surgeons and win market share. The website says robotic programs can help hospitals become “more efficient and cost effective.”

But robotic surgeries cost hospitals more to provide and often are reimbursed by insurers at the same rate as for conventional laparoscopy, according to some experts. A review of 510 hernia repairs at the University of Virginia found that the median hospital cost of a robotic hernia repair was $7,162, versus $4,527 for laparoscopic procedures and $4,264 for open surgeries.

Though individual patients may not necessarily pay more for a robotic surgery, Robertson said, the technology contributes to higher overall health care spending and may divert resources from other priorities. In addition, taxpayer-funded Medicare may end up reimbursing hospitals indirectly for robotic surgeries.

For at least one hospital, robotic surgery didn’t pay off.

Fifty-bed Massena Memorial Hospital in upstate New York ended its robotic services in June to help slash an operating deficit, according to chief financial officer Patrick Facteau.

The da Vinci didn’t increase the hospital’s surgical volume despite a marketing push that included free monthly hernia screenings, Facteau said.

“Part of the sales pitch is, you will get more surgeries and reduce costs,” he said. “We didn’t really see that.”

Nor, he said, did the da Vinci improve the hospital’s surgical quality measures or reduce lengths of stay. Most hernia procedures are already done on an outpatient basis.

The hospital — in the 12,000-person town of Massena, just south of the St. Lawrence River — was paying about $500,000 a year to lease a da Vinci and cover maintenance and instruments, he said.

Unlike most hospitals, which have bought their systems, Massena had the flexibility to ditch its lease. “Once you purchase it, getting out of it is not so easy,” Facteau said.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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