As more and more people enter their golden years, there has been a rise in the number of hip replacement surgeries. A common type of surgery is where the ball and socket of the hip are replaced with a metal prosthesis.
January 13, 2013 FDA Safety Communication and Proposed Order
On January 17, 2013, the FDA released a safety communication stating “metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.” The FDA reported that the source of the problem is metal particles that have worn off of the device and released, which can damage soft tissue and/or bone surrounding the implant. In conclusion, this can lead to implant loosening, pain, device failure, and even the release of metal ions into the bloodstream potentially causing systemic reactions.
Additionally, the FDA released its proposed order changing the approval process for metal-on-metal hip implants. The FDA now requires manufacturers of these implants to go through a complete pre-market approval process, which includes the submission of safety data.