FDA Convenes Advisory Committee to Discuss Hip Implant Failure

The Federal Drug Administration (www.fda.gov) has convened an advisory committee meeting in Washington, DC with the purpose of reviewing data and gathering scientific and clinical opinion regarding the ongoing issues surrounding metal-on-metal, or MoM, hip implant devices. Metal hip implants have been under scrutiny by the FDA, and other organizations, for some time due to numerous complaints worldwide. In 2010 a recall was issued for a metal hip implant device manufactured by Johnson and Johnson’s DePuy Orthopaedics.

Hip-implantIt is estimated that the devices have been implanted in over 500,000 Americans to address degenerative and other hip failure issues. Overall, hip implants are expected to remain functional for 10 to 15 years. However, a review of medical data from England and Wales shows that the MoM version of the device is failing after less than five years in more than 6 percent of patients who have received them. Some countries, including the United Kingdom have suggested the devices not be used at all since there are appropriate alternatives currently in use, such as ceramic hip implant devices.

In addition to implant failure, reports of metal ions entering the bloodstream have been received. Because the device is made entirely of metal, the reports suggest that friction between the metal components during movement, such as walking or running, allow metal particles to wear off the device and enter into the space around the implant, eventually finding their way into the bloodstream.

The FDA, which gathers reports of adverse events involving metal hips, received more than 16,800 complaints between 2000 and 2011.

Hip replacement surgery is among the most common of orthopedic surgeries, allowing millions of Americans to lead pain-free, active lifestyles well into their later years and allowing younger patients with degenerative joint disease to improve hip function and their quality of life. However, a failed hip replacement most often requires a second surgery and replacement, known as a hip joint revision, which can be a technically difficult surgery as well as being risky for older patients.

The advisory committee will gather in Washington to discuss the current state of medical knowledge about the safety and effectiveness of the metal-on-metal hip replacement systems. Using available scientific data, the committee will be asked to consider the risks and benefits of these types of devices. A full report will be made available to the public, via the FDA website, following the meetings.