BHR, Cobalt chrome, Cobalt poisoning, Earl, FDA, Food & Drug Administration, Hip Replacement, metal, metal-on-metal hips, metallosis, NephewSmith, Sleeve, Smith, Smith & Nephew
I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. I have told my story in fits and starts, but it is a typical (with some variations) BHR tale. I was revised in April after 37 months (March 2009) with the poisonous MoM device in my body and yes, the revision is hard and can have complications. But if you are being told you need one for your MoM then you have to take the source of poison and pain out of your body. I had severe pitting edema that had my leg swollen twice its size for a month after revision surgery, and the pain has been horrible this time. I told Earl this and he indicated he’d made it through and so could I, that I must keep on keepin’ on (my version of the gist of what he said). I plan to fight and write and talk about this from now on as often as I can, because it’s a global travesty, that which these avaricious medical device manufacturers have wrought. People need to talk and hear from others who are going through and/or have walked through what they are about to, and they need encouragement to let them know they can make it. I guess that’s what our Dr. Stevens decided, and a wonderful forum it is he has provided us with. Checking in here and writing or reading something from time to time helps me maintain whatever degree of sanity I yet possess, and I personally appreciate what each and every one of you contributes to me, contributes to our growing community.
But I digress. My story is a familiar one, replete with metalosis/AVAL(aseptic lymphocyte dominated vasculitis associated lesion), and my explant next to me here shows signs of the pieces of necrotic flesh that remain on the underside of my BHR Modular Head. My implant has been through the autoclave, so it is not a bio-hazard, as the hospital contended in their effort to send it back to S&N (“To allow their experts to examine it and help me understand what went wrong”). Funny, though, I no longer trust any of these people in this God-awful charade. Not my hospital, surgeon, or S&N — they are all colluding to cover their behinds, to the point where the only direct and informative information I get is from my GP and Physiatrist.
I want to INDEPENDENTLY ANALYZE THIS BHR AND ALL OF ITS PIECES, AND ANY OF YOU WHO HAVE IMPENDING REVISIONS MAKE SURE TO GET YOUR EXPLANTED DEVICE SENT HOME WITH YOU FOR SAME. THIS IS INVALUABLE IN OUR COLLECTIVE NIGHTMARE’S LEGAL STAGE, WHICH WE ARE NOW ENTERING WITH S&N AND IS GATHERING STEAM AROUND THE GLOBE. Smith and his nephew can run, but they cannot hide. They are trying to conceal themselves behind their FDA PMA (pre-market approval) on the BHR, as this two-piece, brand new resurfacing product that was not substantially equivalent enough to warrant the rubber stamp of the FDA’s 510k approval process and went through in vivo PMA (We have now read here how bogus this trial was). The FDA’s 510k is where the device manufacturer places a paper request in front of an FDA clerk that simply says “This one is kind of or at least looks like that last one you stamped”, whereupon said clerk promptly rubber stamps it — ready for the market place, the human body! I have heard of a number of lawyers who will now give a very long look at BHR victims, but only those who have been revised and suffered great harm from AVAL, etc., and have all documented on their surgical record shown on hospital letterhead. PMA or not, S&N simply cannot get away with destroying flesh and bone along with people’s lives. We are human beings, and we should regain our dignity through each and any channel available to us, including writing our stories w/updates on this site to encourage others. We must fight now — we will emerge victorious if we persevere, and any failure to recognize the importance of that will (personally) send me back into depression over the whole fiasco, another revision complication I am just emerging from. Writing to you fellow victims, and having you write to me helps with my staying on an even keel.
One other issue re: the infamous BHR and what my surgeon called a BHR THA. This is where I find S&N most nefarious in the whole BHR ‘shell game’, as it were. I have learned just how unctuous a four billion a year company can be when playing an expensive legal version of hide and seek, and I will try to impart that here.
I was a 55 year-old, lifelong athlete in 2009 who was in great shape, and my new surgeon told me I would be a candidate for the wondrous new BHR, ideal for the middle-aged man who has significant musculature and plans to actively exercise with this new wonder product. I was told by my surgeon that he would attempt to use the new BHR if he could, saying if my bone was not suitable he would move to a total hip (THA) intraoperatively. (We never discussed what that THA product would be composed of). When he came into the recovery room he told me he had performed the THA, but said nothing else. (I didn’t know I had MoM until the THA failed)! But what S&N are saying to all is this: once you have tried to go with the BHR — which has only the two parts, as we know — you are always going to be viewed as a BHR recipient! Even though only the BHR acetabular cup was ‘installed’ in me, I can’t go after S&N because — because — they tried to do a BHR? I’m no attorney, but…?
So this is the ploy they’re using at S&N, and it’s been working well because there has been low-hanging (recalled) fruit for the legal legion. But that is now beginning to change, and if you are a BHR person who has been revised, whether BHR, BHR THA or not, you should email firstname.lastname@example.org, a good man who only wants to help those lives that have been disrupted and/or decimated by S&N (He has too much work and doesn’t want to advertise, but insisted people like me on this site get in touch). AGAIN, FOUR PARTS IN MY THA, AND ONLY THE BHR ACETABULAR CUP WAS PMA! THE OTHER THREE PARTS ARE ALL FDA 510K approved. They are simply using the BHR cup as a legal shield, and their position stands logic upon its head. It cannot possibly prevail and I feel recall of the product imminent.
All right then, that’s about it from this windbag for now, but just think of it: I have a total of FOUR PARTS that comprised my S&N THA: BHR Acetabular Cup, S&N Modular Head, S&N Modular Head Sleeve, and the S&N Anthology Femoral Component (stem and neck). Yet S&N seeks to hide behind their PMA for the TWO-PIECE BHR, even though there was no in vivo trial for the BHR Cup in any configuration separate from the resurfacing system itself! And no lawyer has yet been willing to take them on. But ‘The teams are on the pitch – the whistle blows – the game is afoot’ and the swelling legal ‘wave’ is soon to crash upon them! Let us all tell our tale loudly!
The Truth Will Out!
BTW — The original Op Report from 2009 lists one BHR Acetabular Cup (it’s always listed first), one BHR Modular Head and Sleeve and one S&N Anthology System. My new report lists ‘specimens removed and given to patient’, none of which use the acronym BHR in regard to any piece other then their acetabular cup. They have apparently removed a generic modular head, which I find noteworthy. That is because there IS NO BHR MODULAR HEAD AND SLEEVE, as the hospital originally showed, and I have searched S&N’s catalog for hours without finding a shred of evidence regarding its existence. It is also worth noting that I cannot locate any 510k approval for this ‘device of mystery’ in the FDA’s database after hours of searching.
- Ed’s Smith & Nephew BHR hell gets worse before better… (earlsview.com)
- FDA Action on Metal on Metal Hips – too little, too late… (earlsview.com)
- Laurel’s Story – Smith & Nephew BHR Hip Resurfacing Ruins Another Life (earlsview.com)
- Calling all Smith & Nephew victims (earlsview.com)
- San Diego Chargers team doctor sues Smith & Nephew over botched hip implant | MassDevice – Medical Device Industry News (earlsview.com)
- DePuy Defective Hip Implant Claims | eLocal (elocallawyers.com)
- Case Study: Pharma and Blogging (medmeme.com)
- Dangers of toxic hip implants used in Britain kept secret for years – Telegraph (earlsview.com)
- Dr Tower writes to Senator re concerns about the regulatory malfeasance at the FDA – Metal-on-Metal hip replacement debacle (earlsview.com)
- PALM BEACH, Fla.: Artificial hips corrode, poisoning some patients, lawsuits say | Health | Macon.com (earlsview.com)
Be very vigilant and alert with your health if you have a metal on metal device. I had written before about my plight with a BioMet Magnum M2A that was put in me at 57, over 5 years ago. I had a couple of years with some discomfort and was told more therapy! I kept trying to tell the doctors I was healthy as a horse prior to having this THR. Three years ago it continued to get worse and walking through a grocery store even became a big problem. Then insomnia and panic attacks started and when they hit, I felt I couldn’t breath. It was almost terrifying because you couldn’t even lay down and sleep. Xanax helped. However the actual breathing started becoming a real problem. Then the hip actually dislocated on a few occasions and the pain was unbearable. I now have three levels of hip pain. A level three where it feels swollen and a grease job would help. A level 5/6 where I am convinced the head is not 100% in the socket, it almost feels like it’s cutting me inside but I can limp around with a cane. Then 4 occasions of what I believe is total dislocation and it is nearly ambulance calling pain. However if I immediately sit and endure, with tears, it does seem to revert back into the socket. Sleeping on my right side with foam padding seems to push the device back together and the next day becomes a crap shoot. The original surgeon abandon me when bone scan, x-ray and blood test did not indicate a problem. A second Orthopedic surgeon decided it was muscle and ligament via MRI and I endured multiple injections in the hip. He gave up also. This was at a renowned Orthopedic Clinic in the Denver metro area! In May 2012 I went to University Hospital and they wanted heart and pulmonary evaluation before committing to revision surgery. I was very angry as I just wanted the thing out of me. However they saved my life requiring those tests. The heart was enlarged on right side which pointed to lung issues. A CT Scan of the lungs showed I was full of blood clots. I was in critical care for a while until they could evaluate and get me on Heparin and Coumadin. They think the blood clots started shortly after the original surgery as they appeared to be older. They kept insisting I had to have been in severe pain when these happened. That just never happened in the five years so they are just guessing when they occurred. I now may be on Coumadin the rest of my life! Needless to say nobody will do anything until the clots recede or go away and that may mean years of Warfarin. I just hope and pray that this piece of crap BioMet isn’t destroying my right leg in the mean while. So despite the information about MoM failures and the comment I had seen about health issues seemingly unrelated to your MoM device, make sure your doctor investigates all of your symptoms individually. I kept believing the breathing issues were because of the effort to just move my right leg to walk. I had my mind made up if I got a revision that everything else would magically go away!
With the FDA making a bad decision to allow these MoM devices in the first place and now giving no direction to recall or definitive direction to the medical community, you are essentially on your own to find a surgeon that will clean up the mess. I can’t blame any of them when a potential lawsuit looms that may drag them in. Bottom line: I’m grateful to be alive, but life ain’t a bowel of cherries!
Terry in Colorado
If you are reading this, isn’t it clear that we all need to partner as patients and advocates to get a voice in changing federal public policy on implanted medical device safety and effectiveness? I wrote an essay to compete for one of three scholarships to the Mayo Clinic Social Media Summit October 2012. Please leave your response at the end of the essay before August 3. (Twitter, FaceBook Likes and/or personal positive comments) High numbers of positive actions on that page will help me be selected. http://socialmedia.mayoclinic.org/2012/07/16/joleen-c-scholarship-contest-essay/ My name is Joleen Chambers. Thanks!
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