In a recent medical device safety communication, the FDA states that metal-on-metal hip implants exhibit unique risks in addition to the general risks posed by all implants. According to the updated safety information provided by the FDA, in metal-on-metal hip implants, as the metal ball and metal cup slide against each other during walking or running, metal can also be released from other parts of the implant where two implant components connect.
The information indicates that the metal released may cause some tiny metal particles to wear off of the device around the implant, resulting in damage to bone and/or soft tissue surrounding the implant and joint. The FDA notes that soft tissue damage may lead to pain, implant loosening, device failure, and the need for revision surgery. The FDA adds that at present, it does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to product adverse systemic effects. The information also suggests that different patients may also exhibit varying reactions to the metal wear particles.
The FDA provides orthopaedic surgeons a variety of recommendations, including selecting a metal-on-metal hip implant only if it outweighs that of using an alternative hip system. The recommendations also call for surgeons to inform patients about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced.
The organization also provides patient follow-up recommendations and emphasizes awareness of patients who may be at risk for increased device wear and/or adverse tissue reactions, such as female patients, patients with bilateral implants, patients with resurfacing systems with small femoral heads of 44 millimeters or smaller, patients with suppressed immune systems, patients who are severely overweight, and patients with high levels of activity.
To view the full communication, click here.
[Source: FDA]
