FDA’s MedWatch Safety Alerts: January 2013
Metal-on-Metal Hip Implants: Updated Safety Recommendations
FDA is providing updated safety information and recommendations to patients and health care professionals based on the agency’s current assessment of metal-on-metal hip implants, including:
- the benefits and risks
- the evaluation of published literature
- the results of an FDA advisory panel meeting held in June 2012
Risk: Implant components slide against each other during walking or running, which releases tiny metal particles. These particles may damage bone or soft tissue surrounding the implant and joint. Soft tissue damage could lead to pain, implant loosening, device failure and the need for revision surgery.
Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause discomfort or illnesses.
Recommendations for People Considering a Metal-on-Metal Hip Implant
- Be aware that every hip implant has benefits and risks.
- Discuss your options for hip surgery with your orthopedic surgeon.
- See a list of questions to ask your orthopedic surgeon.
Recommendations for People With Metal-on-Metal Hip Implants
- If you are not having any symptoms and your orthopedic surgeon believes your implant is functioning properly, continue to follow-up routinely with the surgeon every one to two years.
- If you develop new or worsening problems, such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip) or a change in your ability to walk, contact your orthopedic surgeon right away.
- If you experience changes in your general health, including new or worsening symptoms outside your hip, let your doctor or other health care professional know you have a metal-on-metal hip implant.
For More Information
- Information for Patients Considering a Metal-on-Metal Hip Implant
- Information for Patients Who Have Metal-on-Metal Hip Implants
- Metal-on-Metal Hip Implants
- Metal-on-Metal Hip Implants: Safety Communication – Updated Safety Recommendations