June 18, 2014 - In January, 2013, the FDA issued extensive guidelines for metal-on-metal hip devices, stating these implants have unique risks in addition to the general risks of all hip implants. The FDA recommended that surgeons should choose a metal-on-metal hip implant for their patients only after determining that the benefit-risk profile of a metal hip outweighed that of an alternative hip system. The patient’s age, sex, weight, diagnosis and activity level should all be taken into consideration. Patients should be well-informed about the potential risks of metal-on-metal implants.
Patients who have a metal-on-metal hip implant should receive regular follow-up visits including x-rays, soft tissue imaging and blood tests to determine levels of cobalt and chromium in the blood. The FDA noted that certain patients are at an increased risk for adverse reactions from a metal-on-metal hip implant including those patients with kidney problems, female patients, patients receiving corticosteroids, patients with suppressed immune systems, patients with suspected metal sensitivity, patients who are severely overweight and patients with very high levels of activity.
Physicians are advised to be especially aware of any psychological changes in those patients with all-metal hip implants as well as the development of skin rashes, cardiomyopathy, auditory or visual impairments, impairment of kidney function and thyroid issues including neck discomfort, fatigue, weight gain or feeling cold. Even those patients who are currently experiencing no difficulties with their metal-on-metal hip implant are advised to continue to engage in routine follow-ups with their healthcare provider at least every one to two years. New or worsening problems, particularly pain, inflammation, popping, grinding or squeaking of the hip or changes in the ability to engage in regular activities warrant an immediate visit to a physician. It is as yet unknown whether the FDA will impose more stringent regulations for manufacturers of metal-on-metal hip implants and will hold these manufacturers accountable when it becomes clear that the safety of consumers was purposely ignored.