FDA–Approving Medical Devices Before Testing for Safety

Approximately 17 percent of American adults have an implanted medical device, according to a recent survey by the Consumer Reports National Research Center. While millions of Americans live with medical devices implanted in their bodies, the report says that many of these implants have never even been tested for safety. In fact, according to Consumer Reports, manufacturers often are required to do nothing more than file paperwork and pay a “user fee” before bringing their products to the market.

Consumer Reports gave examples of several devices that it says have had significant problems through the years, yet they were not subject to extensive testing before going on the market. In particular, the story discussed the FDA’s 510(k) approval process. Under this process (which is similar to the way generic drugs are approved), medical device makers can get clearance to market a device that is “substantially equivalent” in safety and effectiveness to another approved device when it is used for the same intended purpose.  According to Consumer Reports, the problem is that the companies exploit a loophole in the law that allows them to submit new products to the FDA for instant review, as long as they classify them as an upgrade, even if the product has changes that can affect safety.

The Consumers Union, which is the advocacy arm of Consumer Reports, recommends that Congress make the FDA require that implants and other “life-sustaining” devices be tested as rigorously as drugs.

When a doctor implants an experimental device, that patient is required to undergo surgery. Once the device is found to be faulty, another surgery is required to remove it, adding to the risks.

We have reported about many of these medical devices that have caused pain, harm, and even death to countless patients, due to the current “approval” process in this country.  Numerous and repeated complications of trans-vaginal surgical mesh implants used to correct pelvic organ prolapse, which have been marketed without human testing. As we reported earlier, many of the implants were approved based on a mesh product from Boston Scientific, which was recalled in 1999.

Another device we have previously reported to you are the metal-on-metal hip replacements. There is an increased failure rate in certain models, however, they were approved before proper testing was obtained.

U.S. regulators approved the Lap-Band weight loss device with little or no advance safety testing, as reported in Consumer Reports magazine Wednesday. It says that the FDA’s approval of the device was based on a clinical study of only 299 patients. Of those, 25 percent had their Lab-Bands removed before the end of the 3-year study, due to complications or failure to lose enough weight. Allergan Inc. has sold more than 650,000 Lap-Bands worldwide. A year ago, the FDA approved the Lap-Band for use in patients that are less obese. The FDA’s approval was based on a study that showed 80 percent of patients who used the device had lost at least 30 percent of their excess weight and kept it off for one year. Does that make it “safe?”

Advocates for industry reform in Washington say it is difficult for lawmakers to muster enough votes to ensure the passage of a bill to grant the FDA authority to reject a 510(k) device application.

Some people have come forward in other ways. A few months ago, we reported to you that in January, FDA whistle-blowers leaked information to congressional staffers in 2009 that warned of a potentially unsafe cancer-screening device, which was receiving government approval. Those former employees have filed suit against the FDA, alleging that their supervisors spied on their work computers, using that information to harass and fire them.

Patients need to do research on their own before having medical devices implanted in their bodies. It is unfortunate that we cannot count on the FDA regarding the safety of medical devices today. It takes years after a device is on the market to find out if there are problems or recalls with that device. It is better to be safe than sorry.

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