Federal regulators recently announced plans to tighten restrictions on the sale of all-metal hip implants which have been shown to fail at alarming rates sometimes within years of implantation. The U.S. Food and Drug Administration’s new proposal would halt the sale and approval of all-metal hip implants until medical device manufacturers can affirmatively show that these devices are safe for consumers to use.
Hip implant manufacturers are currently only required to show that their all-metal hip implants are similar to devices that are already on the market. The New York Times reports that the FDA currently does not force companies to conduct clinical studies to make sure that their medical devices are safe for consumer use.
Some estimates indicate that all-metal hip implants were used in a third of all hip implant procedures and that 500,000 patients have implants with a metal ball and cup. All-metal implants were not adequately tested before being released to the market and have shown to have high failure rates.
All-metal implants can wear prematurely and send metal debris throughout the body. There are thousands of patients who have experienced severe bone and tissue damage which can be permanently disabling. This large-scale device failure has spawned a wave of product liability litigation and has finally caused the FDA to recommend limiting the sale of these devices.
Federal regulators also recommend blood testing for hip implant patients who are experiencing symptoms that could indicate device failure. Blood tests can detect whether the implants are releasing potentially harmful metallic ions into a patient’s body. These patients may also be able to file product liability claims against their hip implants manufacturers to recover costs arising out of their hip implant removal surgery and related medical problems.
Source: New York Times, “F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants,” Barry Meier, Jan. 16, 2013