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Device Safety and Regulations Questioned in The Bleeding Edge

Among the film’s many questions: Is FDA’s 510(k) process adequate for patient safety?

Image source: kentoh/Shutterstock

Netflix’s movie, The Bleeding Edge, is about allegedly unsafe medical devices, how they got to market, and how difficult it is to get them off the market. Living in New York, I actually saw it in a movie theater. It has also received a modest amount of press with various radio, print, and online interviews.

The principals behind the movie, Kirby Dick, Amy Ziering, and Amy Herdy, are established documentary filmmakers as is evidenced by the high production values that go well beyond talking heads and statistics. The issue of faulty medical devices is approached through the personal stories of victims, detailing medical, economic, personal, and social impacts. The primary devices addressed are Essure birth control implants (recently withdrawn from the market), gynecological mesh (which is currently the subject of multiple class-action and individual lawsuits), and reported cobalt poisoning from artificial hips. Getting passing mentions in the film are the inferior vena cava (IVC) filter, breast implants, morcellators, and the da Vinci surgical robot. The primary issue cited with da Vinci is what is described as ambiguous training and experience requirements before it can be used safely. (The learning curve part of training—how many do you have to do before you become good at it—is generally something that gets too little attention in surgery and implantation.)

The film criticizes the process by which all the devices cited (except Essure and current breast implants) came to market—the 510(k)—for a lack of adequate pre-market testing. It was also noted that a curiosity of the 510(k) process is that a recalled device can serve as a predicate. Also cited is the alleged disconnect between claims that manufacturers often make about safety and what is actually known, especially in the absence of premarket testing and only short term follow-ups.

The adequacy of 510(k) process has received a great deal of attention over the years. In one recent IVC filter court ruling, the judge asserted that “the 510(k) process is not a safety review.” In this regard, an interesting piece of advice appeared in 2014 in an online Guest Column in Med Device Online on 510(k) preparation: “We need to acknowledge the differences if they are to our advantage and show that, although they exist, they will not impact the safety, efficacy, or performance of the device. If the differences are not to our advantage, however, we should not bring them up prophylactically but be prepared to respond to them if and when we are asked.”

Despite the process’s limitations, when manufacturers become defendants, they would like it to be the case that 510(k)s carried the same level of liability protection that a PMA does, while also enjoying the relatively low scrutiny that their 510(k)s have enjoyed. This hinges in part on whether “substantial equivalency” is the same as proof of safety and efficacy. In this regard, I once heard the somewhat circular argument from an FDAer that since FDA is mandated to only allow on the market devices that are safe and effective, if a device is on the market, then it must be safe and effective. On the other hand, some FDA documents use “substantially equivalent” and “proof of safety and effectiveness” as separate phrases, although without clarity on the degree of distinction they are making. When the Institute of Medicine studied the 510(k) process, they concluded that it could not ensure safety and efficacy. The PMA process also gets criticism in the movie for its weaknesses, especially when compared to drug testing, which was said to be far more rigorous.

The film also criticized the postmarket process for tracking medical device problems in part because of the suspected vast underreporting and in part because reporting is voluntary for physicians and often contrary to their self-interest. Better postmarket surveillance is a current topic on FDA’s agenda. Also mentioned in the movie is the movement of personnel back and forth between industry and FDA, which is alleged to further taint the rigor of FDA review. In this regard, we might recall that the current head of FDA was a venture capital partner specializing in healthcare and medical devices, a fact omitted from his FDA online bio.

The importance of innovation also received attention in the film, including commentary that innovation itself does not automatically mean better or even good. What it means is simply new or different. In this regard, an expert in one of the mesh litigations once testified that “Yes, the product in question was unique—it was uniquely bad.” Advice given to the public at the end of the film included to avoid new without clear evidence of good, avoid inexperienced users, and do your own research.

While the movie did include some defenses of past and current practices, it is fair to say that it particularly focused on bad patient outcomes from allegedly bad devices that made it through a weak regulatory system.

William A. Hyman

William A. Hyman is a professor emeritus in the department of biomedical engineering at Texas A&M University and adjunct professor of biomedical engineering at the Cooper Union. Reach him at [email protected].

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