Medical Implant Devices and the FDA: User Beware? (part 1)

When the U.S. Food & Drug Administration (FDA) approves a medical device designed to improve your health, can you assume the device is safe? Not so fast, according to some critics.

Modern medicine relies more and more on implantable medical devices to help certain patients—from artificial hips and knees to coronary stents and pacemakers, from cataract lenses to breast implants. Yet remarkably, as author/reporter Jeanne Lenzer points out in a recent interview, less than 1 percent of FDA-approved medical devices even undergo clinical trials. (By comparison, drugs must go through at least two trials prior to approval.) Even devices considered to be moderate or high-risk somehow get approved for market without a trial—as many as 400 such devices between 2008-2012, according to one study.

“The overwhelming majority of medical devices that are on the market, that are implanted in patients, undergo no clinical trials,” she says. “So of the very high-risk devices capable of causing serious injury or death, those devices, only 5 percent even underwent two clinical trials, and even those clinical trials weren’t necessarily trustworthy.”

Getting Worse, Not Better

While you’d think increased awareness of the problem would cause a move to tighten the FDA’s approval process, the government appears to be heading in the opposite direction. According to Drugwatch, new rules going into effect this year will actually hasten the FDA’s approval process so medical devices can be released to the market even sooner—a move that critics say will make a bad problem even worse. Equally ironic is that fact that the FDA admits it receives hundreds of thousands of reports per year of incidents, injuries and deaths related to medical devices—and that’s just the ones that get reported.

Many medical devices do work properly and safely, doing what they are intended to do—but how can patients protect themselves from unsafe devices if the FDA is falling short in its testing process? Until regulations and testing improve, it falls on the patients and their families to be proactive, to do their own research and retain the freedom to say “no” to a device if they have any concerns. In the meantime, if you or a loved one has suffered due to a malfunctioning medical device, our Washington D.C. medical malpractice attorneys may be able to help. Call us to learn more.