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Manufacturers who want to keep selling all-metal hips will have to prove that they’re safe and effective, according to proposed new rules from the Food and Drug Administration. Incredibly, for the past decade manufacturers have been aggressively marketing the devices as being better than conventional varieties without that evidence, to the great harm of patients.
Last year in our report on dangerous medical devices, we highlighted evidence that patients with all-metal artificial hip implants were suffering serious side effects, including pain, infections, muscle lesions, and neurological problems such as depression and deterioration of hearing and eyesight, as a result of reactions to metal debris wearing off their implants. At the end of this blog is a video highlighting one such victim, an Alaska orthopedic surgeon, Dr. Stephen S. Tower, whose research was cited in the the FDA’s announcement.
At the peak of the craze for all-metal hips in 2008, they accounted for about 40 percent of all hip replacements done in the U.S., according to new estimates by Steven M. Kurtz of Drexel University. He estimates about 755,000 Americans have been implanted with the hips. Their use has dropped dramatically in recent years as awareness of their dangers has spread.
The FDA regulations announced yesterday specify that once the new rules become final, likely to happen sometime later this year, manufacturers will have 90 days in which to file applications that include the results of clinical trials and other “valid scientific evidence” showing the hips are safe and effective. If they don’t, they’ll no longer be able to sell them in this country.
“I think it’s a good thing,” Tower told us, “but in a lot of ways it’s a formality, because the use of the devices has practically gone to zero anyway.”
Manufacturers we contacted yesterday said they were still studying the FDA’s proposal. Zimmer, once a major purveyor of the all-metal hips, has stopped selling them in the U.S. because “the demand is reduced so much they’re not commercially viable,” said media spokesman Garry R. Clark.
If you have an all-metal hip, here are symptoms to watch out for, according to the FDA:
- Swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip), and/or a change in ability to walk.
- General hypersensitivity reaction (skin rash)
- Deterioration in your hearing or eyesight.
- Psychological status change (including depression or cognitive impairment)
- Kidney problems
- Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold)
Anyone who experiences these symptoms should seek medical attention and, in particular, consider tests that detect elevated levels of the toxic metals cobalt and/or chromium in the bloodstream.
- F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants (earlsview.com)
- FDA Issues New Cautionary Guidelines for Metal-on-Metal Hip Implants, Parker Waichman LLP Reports (prweb.com)
- Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle (earlsview.com)
- Hip Implants Can Cause Tissue Damage, Says FDA (webpronews.com)
- Metal-on-Metal Hip Implants: FDA to Propose Strict Regulations for All-Metal Hips that Could End Sales of the Devices, Bernstein Liebhard LLP Reports (prweb.com)
- FDA Reports Metal-on-Metal Hip Implants Cause Soft Tissue Damage (medicalnewstoday.com)
- New Metal-on-Metal Hip Implant Guidance from FDA Instructs Doctors to Consider Blood Tests for Patients Experiencing Symptoms (prweb.com)
- FDA Executive Summary Memorandum – Metal-on-Metal Hip Implant Systems – June 27-28, 2012 Meeting (earlsview.com)
- Metal-on-metal hip implant risks ‘unique’ (cbc.ca)
- Doctors Weigh Risks of Metal Hips as FDA Tightens Reviews – Bloomberg (bloomberg.com)