The FDA received the authority to approve medical devices in 1976. At that time, it said that medical devices already on the market could remain there without additional testing. For products introduced since that time, the FDA testing and approval process clears more than 90% of them through an expedited 510(k) process. Under the 510(k) process, if a product is “substantially equivalent” to an existing product, it’s cleared to go to market without additional testing. (If the initial product was already on the market prior to 1976, and never received testing, then the new product won’t be tested either.) If a medical device manufacturer can tie a new product to an ancestor product already on the market, that product is good to go.
For instance, the surgical mesh used in transvaginal prolapse repair derived from the surgical mesh that’s been used for hernia repair since the 1950s. The ancestor form of this transvaginal surgical mesh had been around since before the FDA received its 1976 mandate. So the FDA testing and approval process cleared the newer version of the surgical mesh for release into the market for transvaginal prolapse repair without further testing.
The FDA testing and approval process requires fewer than 10% of medical devices to be tested in patient studies before going to market. Such devices include those like pacemakers which pose immediate and high risks to health and life. But other implanted medical devices (like transvaginal surgical mesh or hip replacement joints), which become parts of your body, require no FDA testing and approval process.
When these medical devices fail or reveal a serious flaw, they might not end your life at once like a failed pacemaker might. But they might cause you prolonged pain and dangerous complications. Medical bodies, citizens’ organizations and others are beginning to recognize the weaknesses of the FDA testing and approval process and call for reforms. These calls for reform coincide with an updated FDA warning about the dangers of transvaginal surgical mesh repair. At the same time, medical device manufacturers are clamoring for a faster and more streamlined process to get their devices onto the market.
The battle lines have been drawn, and the first shots have been fired in this conflict of purposes. But we may not see the resolution to the contest for some time. The wheels of government often creak along quite slowly.