In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

Oz did not respond to a request for comment on that statement.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,’” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

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.

Subscribe to KFF Health News’ free Morning Briefing.

Bill Hall, 71, has been fighting for his life for 38 years. These days, he’s feeling worn out.

Hall contracted HIV, the virus that can cause AIDS, in 1986. Since then, he’s battled depression, heart disease, diabetes, non-Hodgkin lymphoma, kidney cancer, and prostate cancer. This past year, Hall has been hospitalized five times with dangerous infections and life-threatening internal bleeding.

But that’s only part of what Hall, a gay man, has dealt with. Hall was born into the Tlingit tribe in a small fishing village in Alaska. He was separated from his family at age 9 and sent to a government boarding school. There, he told me, he endured years of bullying and sexual abuse that “killed my spirit.”

Because of the trauma, Hall said, he’s never been able to form an intimate relationship. He contracted HIV from anonymous sex at bath houses he used to visit. He lives alone in Seattle and has been on his own throughout his adult life.

“It’s really difficult to maintain a positive attitude when you’re going through so much,” said Hall, who works with Native American community organizations. “You become mentally exhausted.”

It’s a sentiment shared by many older LGBTQ+ adults — most of whom, like Hall, are trying to manage on their own.

Of the 3 million Americans over age 50 who identify as gay, bisexual, or transgender, about twice as many are single and living alone when compared with their heterosexual counterparts, according to the National Resource Center on LGBTQ+ Aging.

This slice of the older population is expanding rapidly. By 2030, the number of LGBTQ+ seniors is expected to double. Many won’t have partners and most won’t have children or grandchildren to help care for them, AARP research indicates.

They face a daunting array of problems, including higher-than-usual rates of anxiety and depression, chronic stress, disability, and chronic illnesses such as heart disease, according to numerous research studies. High rates of smoking, alcohol use, and drug use — all ways people try to cope with stress — contribute to poor health.

Keep in mind, this generation grew up at a time when every state outlawed same-sex relations and when the American Psychiatric Association identified homosexuality as a psychiatric disorder. Many were rejected by their families and their churches when they came out. Then, they endured the horrifying impact of the AIDS crisis.

“Dozens of people were dying every day,” Hall said. “Your life becomes going to support groups, going to visit friends in the hospital, going to funerals.”

It’s no wonder that LGBTQ+ seniors often withdraw socially and experience isolation more commonly than other older adults. “There was too much grief, too much anger, too much trauma — too many people were dying,” said Vincent Crisostomo, director of aging services for the San Francisco AIDS Foundation. “It was just too much to bear.”

In an AARP survey of 2,200 LGBTQ+ adults 45 or older this year, 48% said they felt isolated from others and 45% reported lacking companionship. Almost 80% reported being concerned about having adequate social support as they grow older.

Embracing aging isn’t easy for anyone, but it can be especially difficult for LGBTQ+ seniors who are long-term HIV survivors like Hall.

Related Links

• Americans With HIV Are Living Longer. Federal Spending Isn’t Keeping Up. Jun 17, 2024
• ‘Stonewall Generation’ Confronts Old Age, Sickness — And Discrimination May 22, 2019
• Staying Out Of The Closet In Old Age Oct 17, 2016

Of 1.2 million people living with HIV in the United States, about half are over age 50. By 2030, that’s estimated to rise to 70%.

Christopher Christensen, 72, of Palm Springs, California, has been HIV-positive since May 1981 and is deeply involved with local organizations serving HIV survivors. “A lot of people living with HIV never thought they’d grow old — or planned for it — because they thought they would die quickly,” Christensen said.

Jeff Berry is executive director of the Reunion Project, an alliance of long-term HIV survivors. “Here people are who survived the AIDS epidemic, and all these years later their health issues are getting worse and they’re losing their peers again,” Berry said. “And it’s triggering this post-traumatic stress that’s been underlying for many, many years. Yes, it’s part of getting older. But it’s very, very hard.”

Being on their own, without people who understand how the past is informing current challenges, can magnify those difficulties.

“Not having access to supports and services that are both LGBTQ-friendly and age-friendly is a real hardship for many,” said Christina DaCosta, chief experience officer at SAGE, the nation’s largest and oldest organization for older LGBTQ+ adults.

Diedra Nottingham, a 74-year-old gay woman, lives alone in a one-bedroom apartment in Stonewall House, an LGBTQ+-friendly elder housing complex in New York City. “I just don’t trust people,“ she said. “And I don’t want to get hurt, either, by the way people attack gay people.”

When I first spoke to Nottingham in 2022, she described a post-traumatic-stress-type reaction to so many people dying of covid-19 and the fear of becoming infected. This was a common reaction among older people who are gay, bisexual, or transgender and who bear psychological scars from the AIDS epidemic.

Nottingham was kicked out of her house by her mother at age 14 and spent the next four years on the streets. The only sibling she talks with regularly lives across the country in Seattle. Four partners whom she’d remained close with died in short order in 1999 and 2000, and her last partner passed away in 2003.

When I talked to her in September, Nottingham said she was benefiting from weekly therapy sessions and time spent with a volunteer “friendly visitor” arranged by SAGE. Yet she acknowledged: “I don’t like being by myself all the time the way I am. I’m lonely.”

Donald Bell, a 74-year-old gay Black man who is co-chair of the Illinois Commission on LGBTQ Aging, lives alone in a studio apartment in subsidized LGBTQ+-friendly senior housing in Chicago. He spent 30 years caring for two elderly parents who had serious health issues, while he was also a single father, raising two sons he adopted from a niece.

Bell has very little money, he said, because he left work as a higher-education administrator to care for his parents. “The cost of health care bankrupted us,” he said. (According to SAGE, one-third of older LGBTQ+ adults live at or below 200% of the federal poverty level.) He has hypertension, diabetes, heart disease, and nerve damage in his feet. These days, he walks with a cane.

To his great regret, Bell told me, he’s never had a long-term relationship. But he has several good friends in his building and in the city.

“Of course I experience loneliness,” Bell said when we spoke in June. “But the fact that I am a Black man who has lived to 74, that I have not been destroyed, that I have the sanctity of my own life and my own person is a victory and something for which I am grateful.”

Now he wants to be a model to younger gay men and accept aging rather than feeling stuck in the past. “My past is over,” Bell said, “and I must move on.”

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.

Subscribe to KFF Health News’ free Morning Briefing.

This article first appeared on KFF Health News and is republished here under a Creative Commons license.