Metal-on-Metal Hip Implants: New Safety Information
March 1, 2013 | Evaluations & Guidance
On January 17, 2013, FDA issued a Safety Communication updating its recommendations on the use of metal-on-metal hip implants. Included in the guidance are recommendations for patients who have or are considering metal-on-metal hips; recommendations for surgeons before the surgery and during patient follow-up and for imaging the implants; and considerations for device revision. The recommendations are based on FDA’s evaluation of the current literature, as well as on the results of a June 2012 FDA panel meeting on metal-on-metal hip implants.
The Safety Communication reviews the specific risks related to metal-on-metal hip implants—for example, that their use can result in bone or soft-tissue damage caused by metallic debris that is shed from the implant components. Such damage can lead to pain, implant loosening, and device failure, and could necessitate revision surgery. Additionally, metal ions released by the implants can travel to other parts of the body, where they may cause adverse reactions. (FDA states that further study is needed to determine the specific concentration of metal ions necessary...