The FDA is proposing rules that could stop manufacturers from selling all-metal hip implants unless the devices are proven safe and effective, according to news reports. High rates of early device failure and reports of metal debris in the body prompted the FDA to consider stricter regulations.
In conjunction with the news, the FDA released updated safety information on all-metal hip implants. Here are answers to some common questions:
What are all-metal hip implants?
Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys. They may be part of a total hip replacement system or a resurfacing hip system in which a metal covering caps the femoral bone.
What problems have occurred with these devices?
When the metal parts rub against each other, such as during walking or running, tiny metal particles wear off the device and may cause damage to surrounding bone and soft tissue.
If soft tissue damage does occur, it may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place).
Metal ions also may enter the bloodstream and cause symptoms or illness elsewhere in the body. Problems outside the hip areain the skin, heart, nervous system, kidneys and thyroid glandhave been reported.
Whether and when a reaction might occur varies by individual.
Who should not consider an all-metal implant?
If you’re considering a hip implant, talk to your orthopaedic surgeon about alternatives, such as metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal.
In general, metal-on-metal hip systems are not meant to be implanted in patients who have kidney problems, allergy or sensitivity to metals, or a suppressed immune system. It’s also unsuitable for women of childbearing age and patients receiving high doses of corticosteroid medications, such as prednisone.
What if you already have an all-metal hip implant?
If you experience pain, swellness, numbness or noise from your hip or a change in your ability to walk, contact your orthopaedic surgeon right away.
People with an all-metal implant who feel fine should consult with their doctor and have routine physical exams and radiographs every year or two.
New York Times