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FDA cracks down on all-metal hip replacements.’
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.
Click here to see the video attached to the article.
FDA safety communication: metal-on-metal hip implants
Information for patients who have metal-on-metal implants (FDA)
- 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)
Another Smith & Nephew Birmingham Hip Device friend of mine and I read the new and exciting move the FDA is making, NOT.
The FDA is doing this to calm the storm, the FDA has all the necessary data in front of their noses, enough data to intelligently take metal on metal hips off the market.
The decline in sales over the past several years of MOM hips, the collected data that is in the FDA’S hands, the adverse reports over the last several years has sky rocketed, WHAT are you waiting FOR FDA 1000’s of more people to suffer even more so because you are still in bed with the manufacturers ???
In the FDA’s proposal, my friend made mention the FDA doesn’t suggest any testing for those recipients of MOM hips that are not experiencing hip problems presently.
Don’t worry you are OK, I pray that the folks not having problems with their MOM hips continue to do well, however, BEWARE problems could surface 1-7 years post op.
Then the FDA states they don’t THINK ( they really don’t think or use COMMON SENSE, or LOGIC) in high levels of metal ions in the blood to localized lesions or the need for revision surgery. YET THERE ARE SEVERAL STUDIES POSTED BELOW THE ARTICLE THAT WARN OF METAL ION HAZARDS.
SOUNDS LIKE MORE DOG CHASING THE TAIL BULLSHIT.
Why is the obvious so difficult for the FDA my friend asks, my response was
CORRUPTION, CORRUPTION, CORRUPTION.
THE comments about loss of tissue, means nothing, what they should tell us is the truth: YOU COULOD LOSE ENOUGH TISSUE TO BECOME CRIPPLED, THEN I AND OTHERS WOULD KNOW WHAT THE HELL THE MANUFACTURERS ARE SAYING OR THE FDA IS GUESSING.
My friend is concerned that Smith & Nephew’s Birmingham Hip isn’t mentioned. That’s because they think they are sheltered by the pre-emption laws, they are not as large a manufacturer of MOM devices as some of the other device companies.
Yet Smith and Nephew continues to spit out statistics their BHR hip out performs all other resurfacing devices, that is true, however, the number of failures is way over the acceptable percentages, thus their device is worse than others, don’t be fooled by their statistics and data. Sure the bhr out performs competition, especially when the bhr is the only competition in mom hips.
They think they are going to sneak under the wire and all of this will just blow over in time; the same thinking of the FDA.
I have bad news for both Smith & Nephew and the FDA this is only going to get worse.
Had there been proper protocol, FDA follow up etc. etc. perhaps I would not be crippled along with 1000’s of others suffering unnecessarily.
This appears to be nothing more than a ploy by the FDA to smooth things out in the public’s eyes.
If the FDA really wants to regain public confidence take these hazardous to human health metal on metal devices off the market.
We should be looking to prosecute the very manufacturer’s ceo’s, by withholding valuable information as to the adversities of these devices innocent folks lives have been destroyed FOREVER. That is a criminal offense and these people belong in prison.
If we want the absolute truth about the manufacturers prior knowledge, throw a few of these crooks in jail, I am confident some ceo’s will be more than happy to tell the truth.
Last, Dr. Maisel needs to resign especially in lieu of his PROSTITUTION non-sense.
How can I have any faith in him holding any position within the FDA???
If he thinks paying a prostitute for sex is OK I can only guess what goes on when HE
is discussing matters with medical device manufacturers. Is my safety being compromised by an individual like HE ????
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