arthritis, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, depuy hip recall, FDA, Food & Drug Administration, hip, Hip recall, Hip Replacement, hip replacement failure, hip resurfacing, hip revision, metal, Nephew, NephewSmith, Smith, Smith & Nephew
by Howard Sadwin
Another Smith & Nephew Birmingham Hip Device friend of mine and I read the new and exciting move the FDA is making, NOT.
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 COULD 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 ????
- FDA cracks down on all-metal hip replacements (earlsview.com)
- 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)
- Howard Sadwin – Video of Howard’s battle with the damage from Smith & Nephew BHR hip (earlsview.com)
- Come out front Smith & Nephew – we have had your medicine – time for yours… (earlsview.com)
- FDA Executive Summary Memorandum – Metal-on-Metal Hip Implant Systems – June 27-28, 2012 Meeting (earlsview.com)
- New Metal-on-Metal Hip Implant Guidance from FDA Instructs Doctors to Consider Blood Tests for Patients Experiencing Symptoms (prweb.com)
- Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle (earlsview.com)
- Doctors Weigh Risks of Metal Hips as FDA Tightens Reviews – Bloomberg (bloomberg.com)
- Hip Implants Can Cause Tissue Damage, Says FDA (webpronews.com)