In this Birmingham product liability blog, we have been following the story of defective hip implants for a long time. When discussing defective medical devices like the Stryker Rejuvenate and ABG II, one issue that keeps coming up is how the Food and Drug Administration, which regulates medical devices in the U.S., allowed these hazardous devices to be marketed and sold to people in Alabama and across the country.
The FDA has apparently heard criticism of its approval process, under which medical devices generally do not need extensive testing before receiving approval if its manufacturer can show that it is "sufficiently similar" to a device already on the market. Devices such as the Rejuvenate and the ABG II were approved through this loophole, only to cause debilitating complications in thousands of patients. In response, the FDA was expected to announce on Jan. 17 that it was proposing a new rule to require more proof from device makers that their products are safe.
The proposed rule would end the "sufficiently similar" loophole and require medical device companies to show a new device is safe and effective. The FDA gained the power to make this change through a law Congress passed in 2012, in response to the rash of problems with Stryker hips and other all-metal hip implants.
While this rule, if approved, may be a step toward allowing fewer defective devices onto the market, it may not have much effect on already approved products. Metal-on-metal hips are now used in just five percent of hip replacements.
Source: The New York Times, "F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants," Barry Meier, Jan. 16, 2013