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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 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 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 ????
Respectfully
Howard Sadwin
Related articles
- 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)
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Sadly, Howard, it’s now become apparent that for those of us in the US, and seemingly the rest of the world, for that matter, that corporate power far exceeds the power of the people. Like you and the many other MOM ‘guinea pigs’ out there, I too feel nearly helpless in the face of this corporate onslaught. Here in the US, both of us are clearly under the thumb of these lobbyists in DC. It’s like Boss Tweed writ large, and corruption is again king. The manufacturers who are now ‘under the microscope’ of investigative journalists and lawyers have lobbyists on K-Street (today’s Tammany Hall), who now write the bills that become law in this country, both figuratively and on literally. Few members of our congress actually read the bills they vote on, as that vote has already been cast by their corporate masters.
And it seems it’s all about the Rule of Law until it applies to these profiteers, for whom ‘laws’ do not apply. These rules are clearly applied differently, depending on the depths of the perpetrators pocket. And there can be little doubt we are up against very deep pockets in this struggle, such that there often appears very little can be done about it. Too bad the ‘corporate marionettes’ haven’t been able to finalize their coveted ‘tort reform’ in Washington, or people like us would simply be left behind. We’d be little more than collateral damage, all in the ‘noble’ interests of improving people’s lives! If they’re wasn’t a legal team helping me, I would have little recourse, other than picketing my hospital wearing a sandwich board leaning on two canes (I couldn’t really do that physically). But there are many very tenacious and ethical counselors of the law out there who’s goal is to protect us from those we assumed were our protectors, and as this MOM (‘Island of Dr. Moreau’) experiment spirals out of control, it will eventually fall to pieces on the ground .
Of course, the multinational conglomerates who are behind all of this won’t really be affected much overall, even after all of the horrible MOM details are brought to light and all of the (known) cases settled, after which they’ll never admit guilt and their shareholders won’t take any noticeable ‘hit’, so to speak. I would rather face them in a court of law than settle, because even in ‘losing’ monetarily I’ll take the risk. I want most of all now to draw attention to the crimes committed and help ensure these avaricious bastards are pushed into the light of day.
I can’t speak for the world, but to a great extent our democracy here is looking more and more like a ‘corptocracy’, where we’re becoming an oligarchic nation where corporate greed is gaining near-total control. America looks more and more to be ruled by plutocrats, a club you can’t easily join. From my perspective, a democracy that requires a political candidate to be wealthy cannot be called one. To wit, about 47 percent of the new US Congress, or 249 current members, are millionaires!
I didn’t intend to wander into the political realm, but that’s obviously where our regulatory agencies are found and funded. Those governmental agencies were created for the protection of ‘we the people’ and have failed us miserably, and as you point out, Howard, they still — still refuse to face the failure of these ‘metallic monstrosities’ that have left so many human beings immobile, in horrible pain, with lives and marriages destroyed and much left in ruins. So many brothers and sisters left suffering, where the recliner or the bed are the only places that offer any comfort to the pain that my doctor is convinced is the product of my imagination. (“My revised knee is killing me, doc”, to which he replies upon examing my X-rays (and with great pride and satisfaction that “It’s in there perfectly”, I can’t see what might be bothering you”. He cannot see that which he refuses to look for. I am a problem, his inference my pain is psychosomatic!
I feel we find ourselves in a plight not dissimilar to that of early American colonists. I recall something to the effect of ‘taxation without representation’ or the like. Our taxes pay the salaries of these very officials who are tasked with ensuring our safety. With more and more scandalous information coming to light with every passing day, and more blatant examples of our governments failure to protect us, I am left to wonder: exactly what am I paying my taxes for? Has the FDA provided the service we were led to believe it was created for? In the UK, has the MHRA diligently pursued its tasks? What of the TGA in Australia? Will we see improvement with the transition of that country and New Zealand to the ANZTPA? Hey, it’s a nice looking new acronym, but exactly what will be new?
The good thing we see is how the string has been pulled with the yarn beginning to unravel. This will continue to snowball, so we can at least take heart in the fact that our cause is gathering momentum. And we must “Never, never, never give up”, as Churchill exhorted, and “If you’re going through hell, keep going.”
So for all who are suffering today from the toxic effects of this MOM nightmare, take heart, remain steadfast and keep on keepin’ on, because The Truth Will Out!
Bravo!!!
I would vote for you!!!
Earl
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