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Compliance In Focus
Posted by Sandra Maddock on Thu, Aug 23, 2018

'The Bleeding Edge' Raises Big Questions For Medical Device Manufacturers


Thanks in large part to innovation in the medical device industry, the average human lifespan has nearly doubled in the past hundred years. Medical devices have undoubtedly improved the quality of life for millions of people, too. 

But a provocative new Netflix documentary raises an important question: Is there a point when innovation goes too far?

"The Bleeding Edge," produced by Academy-Award nominated filmmakers Kirby Dick and Amy Ziering, tells the stories of patients who say they’ve suffered serious health problems as a result of recent medical devices being used in their procedures.

For instance:

  • A woman suffers painful cramps, headaches and other problems she believes are due to complications from a permanent birth control device. Using Facebook groups, she finds thousands of other women who all say they’ve experienced similar problems after having the device implanted.
  • An orthopedic surgeon has a chrome cobalt hip replacement and later experiences serious neurological issues, including tremors, memory loss and a psychological breakdown in which he vandalizes a hotel room. He tests his own blood and discovers the amount of cobalt in his system is 100 times greater than normal due to the disintegration of the joint replacement.
  • A woman experiences chronic pain after having a pelvic mesh treatment to improve bladder control. Doctors were unable to fully remove the mesh, and as a result of complications, she is no longer able to have sexual intercourse with her husband.

The filmmakers interview physicians, regulators and others who point to a flawed process for medical device approvals, kickbacks for physicians and other contributing factors.


 The film is already having an impact.

Just days before its release, Bayer announced it would stop selling Essure—the permanent birth control device profiled in the documentary—by the end of the year.

Bayer cited a decline in sales due to other birth control options and “inaccurate and misleading publicity about the device,” rather than patient safety concerns.

“The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades,” Bayer stated in a news release.

Bayer also went on defense in a recent Variety article, criticizing the filmmakers for a lack of understanding about the science and ethics behind medical device trials. A company spokesman pointed out the obvious ethical problems with running randomized or non-blinded trials and having a control group that would be subjected to invasive laparoscopic tubal ligation surgery.

While medical device manufacturers and clinical researchers will no doubt have strong opinions about the film, millions of patients will likely watch it. And the film raises important questions about the medical device approval process, financial incentives and more.

Here are three questions that are sure to spark conversation.

1. Should the FDA Require More Devices to Go Through Premarket Approval?


Most of us in the field are familiar with the history of clinical research and the Medical Device Amendments of 1976, which brought medical devices under control of the FDA.

Medical devices on the market prior to 1976 were grandfathered in, said Jeanne Lenzer, author of The Danger Within Us.

While the premarket approval process (PMA) requires human testing, medical devices can be exempt from this step if the manufacturer can demonstrate a device is “substantially equivalent” to one that has already been proven to be safe and effective. The film raises concerns that this exemption, which we know as the 510(k) premarket submission process, is used too often and for devices where it’s not appropriate.

“That provision, which was meant as an exception...became the rule,” said Dr. David Kessler, a former FDA commissioner. “So the vast majority of devices today, regrettably, are regulated under this framework.”

Today, 98 percent of medical devices go through the 510 (k) FDA approval process, while just two percent go through premarket approval, according to the film.

“Even if the device was recalled because it was dangerous, you can still use it as a predicate and get your device cleared because it’s substantially equivalent,” said Dr. Rita Redberg, editor of JAMA Internal Medicine. “So there are a lot of problems with that 510 (k) system, and that’s how metal-on-metal hips got on the market.”

Stephen Tower, the surgeon who experienced neurological issues after his hip replacement, said the medical community has tremendous incentives to promote new devices and technology over existing ones, even if the older models are working well. He now tells his patients that ‘new’ does not always mean better — in many cases, it means it’s unproven. Although manufacturers have recalled some hip replacements containing cobalt, others are still on the market. More than 10 million people now have joint replacements containing cobalt. Some doctors have questioned whether cobalt is “the new mercury.”

2. Does The Medical Industry Reward Doctors For the Wrong Reasons?


Medical device manufacturing is a lucrative industry, with total revenues of nearly $400 billion globally in 2017. The film is critical of how medical devices are marketed, citing financial incentives for both medical device manufacturers and physicians as a growing problem.

Medical device companies paid doctors more than $8 billion in 2017, according to Open Payments, a CMS website that provides public data about financial relationships between healthcare companies and physicians.

The incentives aren’t always as obvious as writing a check.

Sometimes they come in the form of consulting, teaching or sponsoring a fellowship.

“Most doctors do the right thing and always will to the best of their ability,” said Dr. Martin Makary, professor of surgery and health policy at Johns Hopkins School of Medicine. “But some doctors respond to the perverse incentives of getting paid more for the more you do, regardless of the appropriateness of that medical care. There are kickbacks in the United States today that are entirely legal.”

These financial incentives encourage physicians to use the latest technology even when there’s no apparent benefit to the patient. In some cases, the technology creates added risks.

3. Are Physicians Adequately Trained to Use New Medical Technology?


Dr. Makary cited robotic-assisted surgery as one example of medical technology where the risks can outweigh the benefits.

Intuitive Surgical initially submitted the da Vinci robot through the FDA’s premarket approval process, but an FDA manager intervened to have it approved through the 510 (k) process instead.

“Originally, Intuitive told the FDA that a huge amount of training would be provided as part of the sale of the machine to hospitals,” said attorney Richard Friedman. “But shortly after the FDA gave permission to market, Intuitive scaled back all of the training requirements. If they said your surgeons can use it but they need nine weeks of training, no one is going to buy the machine. So you have surgeons who operate for half a day on pigs, take a ten-question multiple choice test and have a proctor, another surgeon, do two surgeries and then they’re turned loose with the machine.”

Surgeons who use the da Vinci robot themselves said it took much longer before they felt proficient. And when surgeons perform robotic-assisted surgery without proper training, medical experts say the results can be catastrophic.

Several women interviewed in the film said they experienced pelvic organ prolapses after having routine hysterectomies with the da Vinci robot. It should be noted that women who have hysterectomies may already be at a greater risk of pelvic organ prolapses, according to population-based cohort studies. The film doesn’t address whether hysterectomies conducted by robotic-assisted surgery pose a greater risk than traditional hysterectomies.

However, it does raise questions about whether surgeons are adequately trained for robotic-assisted surgery. It notes that Intuitive Surgical advises surgeons to determine for themselves if they’re ready to perform it.

How Should Medical Device Manufacturers Respond?

The medical device manufacturers with which IMARC works conduct themselves ethically and with a “patient-first” mentality without exception. And even though the majority of devices do not go through the full PMA process, the FDA has recently increased its requirement for more clinical data to support devices that are being regulated through the 510(k) process, a point that the film neglected to mention. In addition, the FDA has ordered what's called a “522 Postmarket Surveillance Study” on at least 3 of the devices depicted in the film, including metal on metal hips, various mesh devices, and the Essure system for permanent birth control. With these 522 studies, FDA mandated that additional post-market information be collected due to the nature of the devices. 

While the film paints medical device manufacturers as greedy people who value the bottom line over human beings, that has not been IMARC’s experience. We work alongside incredibly bright, talented people who are trying to find solutions to the problems that afflict us. But things can go wrong. Adverse events do happen. Patients can be harmed. In clinical trials, there are risks that may not even be known to anyone prior to a device being implanted in a human being.

Having said that, medical device manufacturers should be transparent about reporting adverse events and respond with greater transparency to public inquiries about them. They should work with physicians, marketers and others to ensure patients are fully informed about the risks of medical devices, both in the immediate future and in the long term.  And they should work with clinical research professionals and regulators to comply with the most stringent standards of approval — even if that means going above and beyond what is required by law.

The History of Clinical Research

Topics: Medical Device Manufacturers


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