FDA Announces Proposed New Regulations for Metal Hip Implant Devices

Posted in Defective Medical Devices,FDA Regulations on January 21, 2013

Undergoing hip replacement surgery is demanding of the body and requires weeks, months, or up to years, of recovery and rehabilitation, but the final result of improved mobility and well-being usually makes the process worth it. Unfortunately, according to The New York Times, about 500,000 patients who received metal-on-metal hip replacements have reported hip implant failure. In many of these cases, a patient will need corrective surgery, but this is typically after already having to endure physical pain, emotional grief, and other risks, such as the release of metal particles into the body and bloodstream.

On January 17, 2013, the U.S. Food and Drug Administration (FDA) announced its proposal of new regulations that would require all-metal hip device manufacturers to prove that the devices are safe and effective before continuing to sell existing products or get approval for new all-metal designs. The proposed rules include updated safety information and suggestions for patients as well as health care providers. The findings come from the FDA’s evaluation of the benefits and risks of metal-on-metal hip replacement devices. The FDA has also considered published literature and results from the June 2012 Orthopedic and Rehabilitation Devices Advisory Panel meeting.

Although tightening the grip on all-metal hip implant regulations is encouraging, The New York Times suggests it may take a year for the regulations to be finalized, at which time industry lobbyists may object or modify the rules. In the meantime, anyone who is thinking about getting a hip replacement or who has received one in recent years, may want to consider visiting the FDA web page regarding metal-on-metal hip implants for additional information.