News & Resources
J&J to Stop Sales of Metal-on-Metal Hips
On May 16, 2013, Johnson & Johnson announced it would stop selling metal-on-metal hip replacement implants. “The decision to discontinue these products is not related to safety or efficacy, and is not a recall,” according to a company spokesperson for Johnson & Johnson’s subsidiary DePuy Orthopedics, Inc.
The company stressed their decision to stop selling the controversial metal-on-metal hip implant systems was not a recall, but a decision that was based on declining sales, competing products, and proposed regulatory changes by the FDA. In January 2013, the FDA proposed new rules requiring manufacturers of metal-on-metal hips to prove the devices were safe in order to keep selling them. Metal-on-metal hip implants were previously allowed on the market under the FDA’s controversial 510(k) clearance process which did not require clinical trials proving safety or effectiveness, nor were manufacturers required to follow patients post-operatively.
Johnson & Johnson and its subsidiary DePuy Orthopedics, Inc., are currently facing over 10,000 lawsuits across the country due to high failure rates of its metal-on-metal hip implants and due to significant safety concerns that have come under FDA scrutiny during recent years.