June 29, 2012 — A U.S. Food and Drug Administration (FDA) panel met earlier this week to decide whether to issue new guidelines for the 500,000 Americans who have metal-on-metal hip implants. After two days of discussion, some experts suggested that there is little reason to continue to use metal-on-metal hip implants instead of plastic or ceramic designs. Although metal-on-metal hip implants were initially marketed as longer-lasting devices, recent studies from Europe have linked the devices to higher rates of premature failure, corrosion, metal toxicity, and more.
The 18-member advisory committee was chaired by Dr. William Rohr of Mendocino Coast District Hospital, who said, “I do not use metal-on-metal hips, and I can see no reason to do so.” The FDA panel did not raise the issue of recalling metal-on-metal hip implants.
The FDA experts said that patients who have pain, swelling, or other problems with their hip implants should have periodic X-rays and blood tests to check for elevated metal levels. However, the tests are not always accurate, and test results can be difficult to interpret. The panel recommended that people who are not having problems with their hip implant should still undergo annual X-rays.
The panel’s recommendations fall short of official guidelines issued earlier this year by U.K. health regulators, who advised patients with metal-on-metal hip implants to undergo yearly blood tests to check for elevated levels of chromium or cobalt in their bloodstream.
Health officials at the FDA have suggested that they need more time to make any recommendations, because there are many different types of hip implants and groups of patients who receive the devices. Some patients may have higher risks than others — women and overweight people, for example.
The FDA meeting was in response to nearly 17,000 adverse event reports from people injured by metal-on-metal hip implants, as well as several negative scientific studies, and regulatory actions from other countries. Recently, the FDA asked 31 different manufacturers of the devices to begin conducting safety studies. However, the conclusions of the studies could be up to a decade away.
Most metal-on-metal hip implants were fast-tracked through the FDA approval process without conducting safety studies. The FDA’s 510(k) loophole allows the approval of new devices that are “substantially similar” to devices that have already been approved.
In practice, however, metal-on-metal hip implants have shown numerous side effects unique to the design. Over time, the metal parts grinding together can shed tiny particles of chromium and cobalt into nearby tissues or the bloodstream. This can cause damage to tissues, muscle, and bone, or cause metal poisoning in the body. One study also found that the devices corrode more quickly and severely than plastic or ceramic devices.
Every year, approximately 400,000 Americans get a hip replacement. The use of metal-on-metal hips has declined in recent years, from a peak of 40% of all hip implants in 2008, down to 27% in 2010. The use of these devices has plummeted even further in Europe amid safety concerns.
Do I have a Metal-on-Metal Hip Implants Lawsuit?
The Schmidt Firm, PLLC is currently accepting metal-on-metal hip implant induced injury cases in all 50 states. If you or somebody you know has been injured by a metal-on-metal hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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