Why the media must play a bigger role in policing unsafe medical devices

iStock_000044585260_SmallContributor Trudy Lieberman has been tracking the progress of industry-friendly regulatory legislation — the 21st Century Cures Act — through Congress. Here she examines how current medical device regulations are already allowing many faulty devices on the market — and how the media will need to be more vigilant if and when current regulations are further weakened under 21st Century Cures.  


Last September, the Food and Drug Administration convened a panel of experts to publicly examine the safety of Essure, a birth control device sold to more than half a million women over the past 13 years. The device, a coil implanted in a woman’s fallopian tubes, was sold as a way to permanently prevent pregnancies without the need for abdominal surgery and general anesthesia. Despite the touted advantages, more than 5,000 women have reported complications to the FDA, including tubal perforations, allergic reactions, severe pain and bleeding resulting in hysterectomies and hundreds of unintended pregnancies. In the last few years those complaints have multiplied, and more than 20,000 women have turned to Facebook to share their experiences.

Through the years Essure has gotten its share of press, but media coverage has swelled in the past month thanks to the power of Facebook, the FDA’s expert panel meeting, and a study released this month in The BMJ, which concluded that Essure was not associated with a higher risk of unintended pregnancies but was associated with a substantially increased risk of additional operations to fix the complications arising from use of the device. Outlets such as Reuters, the Wall Street Journal, NBC, and the Philadelphia Inquirer ran stories.  A New York Times editorial called for the FDA to consider suspending sales of Essure until better data is available.

In early September, a few weeks before the FDA hearing, came more troubling news about a different medical device–the C.R. Bard Recovery filter.  The Bard Recovery filter is inserted into the body’s largest vein and is intended to prevent blood clots that form in the legs from traveling to the heart and lungs. In a two-part series, which moved beyond the usual safe topics of network news, NBC reported that the filter could migrate through the body, puncture the heart, and had caused 27 deaths and 300 non-fatal medical events. Neither the FDA nor the manufacturer C.R. Bard would talk about the device or NBC’s revelation that Bard may have forged the signature of its employee who refused to sign off on the FDA approval application because of unresolved safety issues. (They did issue statements — see here and here.) Although NBC pointed out that some 20,000 people were estimated to be walking around with the device implanted in their bodies as far back as 2006, it was disappointing that the story of the migrating heart filter received so little media traction except from trade pubs like Fierce Medical Devices and websites sponsored by law firms no doubt trolling for clients.

As good as the NBC story was, it may have gotten more attention had NBC noted that the FDA had sent Bard a warning letter in July which flagged violations of the Food, Drug, and Cosmetics Act. The FDA said Bard had manufactured and marketed its Recovery Cone Removal System, intended to remove Bard filters from the body, without the required clearance or approval from the agency. The warning letter also advised the company that its “complaint investigation procedures do not ensure product complaints are adequately evaluated.” One case was reported by the company as a malfunction of a medical device when it “should have been filed as a death;” others were filed as malfunctions when they should have been filed as “serious injuries,” the FDA said. Scary stuff the public might want to know! When I asked NBC about this omission, a PR official said the letter “was not germane to the heart of our report,” but noted the warning and other legal and regulatory issues facing Bard were discussed in an online piece. The brief online mention, however, hardly communicated the seriousness of the warning.

Media interest in medical devices is a hit or miss affair, and when there is coverage, it usually doesn’t mean that the device, no matter what harm it may have caused, will be pulled from the market. Such devices continue to be sold, potentially causing more harm. The FDA’s response is often to call for stronger warnings or restricted use rather than ask the manufacturer to recall the device. The rationale: It may still help some people. It also helps the seller’s bottom line. In Washington’s current regulatory climate regulated industries rule the roost.

Most devices are approved with very little evidence they work and are safe.

Bard’s Recovery filter, for example, was approved in 2003, but two years later the company took it off the market and swapped it for a different model. Modifications in the new device were intended to prevent complications that had occurred. Both devices were approved under what’s called the 510(k) approval process that allows manufacturers to avoid conducting safety studies if a device is substantially equivalent to another already on the market. Essure was approved in 2002 on the basis of two nonrandomized, nonblinded prospective studies that lacked a comparison group. Since then some post-marketing studies have found problems.

FDA’s panel of experts concluded “that additional research needs to be done” to prove the device is safe, and they called for its use to be limited.  It’s not clear what action the FDA will eventually take.

“Once the device has been implanted and used, it’s hard to pull back because it has become the expected way of practicing medicine,” says Sanket Dhruva, a cardiologist and clinical scholar at Yale. “In the U.S. there’s no systematic reassessment of device safety and effectiveness years later.” And there’s no systematic, comprehensive, and uniform way of collecting complaints through product registries that other countries have which track problems with medical devices. Medical specialty organizations, the government, and even manufacturers sponsor registries in the U.S. Jeff Lerner, who heads ECRI, the independent organization that tests medical devices, drugs, and other healthcare technologies, told me, “A lot of information comes from registries outside the U.S.”

These shortcomings in policing unsafe medical devices argue for increased media scrutiny, including from social media. (Facebook acted as kind of a registry in the Essure controversy, but consumer complaints–as important as they may be–are no substitute for official registries with controls and rigorous data collection practices.) “The press is absolutely critical,” says Dr. Hooman Noorchashm, a cardiothoracic surgeon, who has spent the last few years trying to get a device called the power morcellator off the market. The device treats uterine fibroid tumors but can also spread hidden cancers throughout the body. Noorschashm and his wife, Amy Reed, also a physician who has cancer thought to have been spread by the morcellator, have been on something of a crusade to warn others and challenge the FDA. “Any success we’ve had is because a few Wall Street Journal reporters listened to us,” Noorchashm told me. So far one manufacturer has pulled the product, and the FDA has called for a black box warning, the strictest cautionary label a product can have. “They put out a black box warning and an advisory. That doesn’t protect patients,” he says. “Doctors still think it’s okay.” One Dallas gynecologist  told the Wall Street Journal that he asks patients to sign an informed consent document describing the risks of the procedure, but he added: “We tell them verbally that we don’t think those numbers are correct.”

As the 21st Century Cures Act moves closer to becoming law, media vigilance over medical devices will be even more crucial. The Senate is now considering the bill, which passed the House in July, and the PR campaign to speed up passage is gaining momentum. Earlier this month the Manhattan Institute, a conservative think tank that has provided the intellectual ammunition for the legislation, bought a full-page ad in the New York Times arguing “a new era in science and medicine calls for a new approach at the federal Food and Drug Administration…every American has a stake in this change because everyone will be a patient someday.” The Act would make it easier for devices to pour into the market in this “new golden age of medicine” the ad proclaimed. As I wrote in a previous post, should 21st Century Cures become law, devices will get even less regulatory scrutiny than they get now. Of course, there can be studies after a device has been around for awhile, but research published this summer in JAMA found that post-market studies varied in quality and only about 13 percent were completed between three and five years after approval. That’s a lot of time during which a bad device can be causing harm to unsuspecting patients.

I asked one of the study’s authors, Dr. Joseph Ross, an associate professor of medicine at Yale, how media coverage of devices could be better. Too often, he said, reporters who do cover devices don’t go far enough. “When you stop at the bad event, it doesn’t illustrate the path that got us there.” The larger story is really about the FDA, America’s laissez-faire philosophy of regulation, its insatiable appetite for cures, and the clash of these elements with costs and safety. That story is much harder to tell.

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Joleen Chambers

October 27, 2015 at 3:14 pm

Trudy Lieberman, thank you! The media is welcome to review the chronicle of the medical device industry unearned entitlements and the FDA lax enforcement of regulation that I have collected since 9/2010 when I was invited and attended FDA/CDRH Patient Representative training. OSHI (office of special health issues) never selected me for a panel because a) most (98%+) devices are grandfathered in by 510(k) process and b) they select the Patient Representative that has no opinion about the product. So, in effect, the harmed patients are not in the room when decisions are made. No wonder the profit flows along with the harm! My blog: FiDA Failed implant Device Alliance http://fida-advocate.blogspot.com

Albert

October 27, 2015 at 10:02 pm

That goes the same for the DAVinci surgical robot made by intuitive surgical inc. . 244 deaths! thousands of injuries
3500 lawsuits. Whistleblower’s, marketing, Billions made, documentaries, FDA corruption, know defects for years, also 510(k) approved!

DaVinci WHAT A SCAM!

Media is scared of robots?

“Unplug the robot ” Facebook community page…

Judith A Thompson

October 28, 2015 at 8:24 am

I wonder if there is some way to address the majority of journalists who write on health matters? Reading the above made me more wary of trusting new medical technology. I guess that is a good thing….

Linda Radach

October 28, 2015 at 10:51 am

Thank you, Trudy Lieberman, for addressing these concerns! The FDA has taken an increasingly defensive stance against harmed patients who challenge the ‘insider’ view that everything is running smoothly; providing innovation and protection. Congress does not listen any better than the FDA, so the media has the opportunity to champion the rights of patients asking for safe and effective medical devices. Go for it! There is plenty of unbelievable data related to patient harm and a failure to properly regulate medical devices for safety and efficacy.

Laura Henze Russell

October 28, 2015 at 11:56 am

What goes on now in medical device regulation is a tragedy. The rules are 40 years old, and favor industry over patient safety. To call on Congress to reboot FDA device regulations and put patients first, here is a timely petition for Medical and Dental Device Safety Urgent Reform: MEDDSURGE http://www.petition2congress.com/18325/medical-dental-device-safety-urgent-reform-meddsurge

Jeff

October 28, 2015 at 2:01 pm

More attention needs to be focused on plastic “temporary” bile duct and pancreas stents . Gastroenterology doctor’s insert the devices (ERCP) claiming that they are temporary and will open strictured bile/pancreas ducts. This is further from the truth.I have been under anathesia for ERCP’s and have been told that they will be looking at my ducts.LIARS.
They have been inserting stents in my bile duct and pancreas ducts without my consent. I have referrals from doctors stating that I need surgery to remove them.Xrays also show numerous stents.These stents were on FDA clinical trials,when they first appeared on the market, showing that they did NOT work and were killing the dog and pig subjects(these same EXACT stents).
Under Code of Federal Regulations
Section 803 Title 21
States that the FDA is BOUND by Mandate to self report by
User Facility (Hospital )
Practitioners
Manufacturers
Any and ALL Adverse Events.
No one is reporting in fear of losing money invested in these and all medical devices.

Tammy Jackson

October 28, 2015 at 4:08 pm

Transvaginal Mesh has harmed 100,000’s of women. It has destroyed my life. It has killed women and caused loss of marriages, homes, jobs, ext….why is this in the media…because big Pharm company spend too much on commercial ads…that’s why…

Janis Urban

October 28, 2015 at 4:20 pm

Thank you Trudy Lieberman. As a Mesh Injured Woman who believes that the Fast Tracking approvals of any medical device by the 510(k) clearances is criminal. Once a device is on the market it takes to many years to get it recalled or reclassified. The Greed, Graft and Corruption that surrounds Pelvic Mesh alone would be a Best Seller. The Mesh Injured have been Abandoned by our Government, the Agencies that are in place to protect us and a entire Medical Community and the Main Media. There is no Standard of Care for Mesh Complications and there are many serious complications. Women’s Lives Matter!.

Amy G.

October 28, 2015 at 10:16 pm

Thank you Trudy for informing the public when the medical establishments and our government fail to do so. I was unaware of several devices mentioned except that I’ve been following Dr. Amy Reed’s unfortunate situation caused from the morcellator, which I will never consent to. It goes to show that the FDA and media are both biased in aiding the device manufacturers to continue to profit, regardless of harm. It’s all about protecting profits made by the biggest players – the manufacturers/corporations and hospitals. The FDA should work to protect people, not corporations.

    Howard Sadwin

    October 29, 2015 at 1:01 pm

    Another Human Tragedy- after 21 revision surgeries stemming from a metal on metal hip, life will never be the same. From playing baseball, fishing, working, family etc nine months in the hospital I am grateful to be alive. I can barely walk, pains and aches will be forever, my life has been shortened without any doubt. While in the hospital I began learning about who, how and why this happened and what could I do to prevent this from happening to YOU. I became an advocate by helping patients by sharing information I learned. I traveled to Washington, D.C and spoke in front of the FDA panel hearing held June 27-28, 2012 regarding metal hips. I was proud to have spoken, I met some terrific folks however I could sense the panel was going to do what I have since learned nothing but talk about this and gather more information. There has never been a story told by those patients that have and will suffer for the rest of my (our) life.
    Reporters haven’t exposed the ongoing corruption, kickbacks, beyond the fines a few companies paid for getting caught. They haven’t questioned why certain devices were even approved when the data used in the approval process by the FDA wasn’t even verified or why the FDA rewrote the rule book when it came to approving some devices. All the new proposals made by the FDA to improve this debacle are nothing more than more BS
    When talking to the FOIA (freedom of information) I was told they were 2 years behind in trying to answer peoples request, I received comments from the FOIA saying no to my request, another person spent 30 minutes on phone asking me questions about my request another person told me there were 30,000 pages to review before they could send me information like a dog running in circles trying to catch it’s tail but never does. The FDA doesn’t have the people power to comply with their existing problems. I say to my self and these people are responsible for approving a device that has hurt 1000’s of people and it is still on the market.
    I wish a reporter would talk to me and a few of my hip buddies and tell our story and I don’t mean just the pain and suffering.
    Patients need a voice that will work to change certain laws and protect people as they should. The FDA wasn’t formed to protect and ensure the well being of manufacturers WAS IT ? .