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BHR, Birmingham, Food & Drug Administration, Hip Replacement, hip resurfacing, Hospital for Special Surgery, Medicine, NephewSmith, Smith & Nephew
I applaud your compilation of experiences and data on issues with Smith & Nephew BHR (resurfacing) MOM implants..
I too have similar experience to share in the hope FDA and the medical community begin to wake up and address the issues…
My initial BHR resurfacing was done in August 2009 by one of the leading surgeons for the same in the NY/NJ metropolitan area…In April of 2012, ONLY as a result of reading and seeing class action suits evolve, I became concerned about the possibilities of cobalt/chromium toxicity in the case of MOM devices and subsequent recalls of MOM hip replacements such as the J&J product and elected to have my blood tested ….I found my levels were literally off the charts!
I had NO symptoms of this wear and device failure at that point while having alarmingly high levels of cobalt & chromium, that is the scary part..People can have this toxic blood poisoning w/o knowing for years! A ticking time bomb.
Fast forwarding to July of 2012 and following having a MARS ( MAVRIC) specialty MRI at the NYC Orthopedic, “Hospital for Special Surgery” which detected the presence of metal debris, beginnings of tissue damage and bone erosion it was validated the device was failing after less than 3 years! The solution, a DO OVER..extract the device and have a total MOP hip replacement..This is now scheduled for December.
During my last consult with the original surgeon, he confided that his confidence in the Smith & Nephew BHR ( Birmingham Hip resurfacing) was definitely shaken and questioned just how many patients out there since 2006 would show evidence of this problem if they in fact did have their blood tested for Cobalt & Chromium. As of July of this year he was NOT taking on any new patients for this hip resurfacing and it is my understanding that the #1 surgeon at the Hospital for Special Surgery ( relative to #’s of devices implanted) has also subsequently discontinued performing this surgery as well.
Unfortunately, this could be the tip of the iceberg for this problem and I encourage all BHR patients take the initiative in the interest of self advocacy to have their blood tested because there is NO present medical or post surgery protocol to monitor cobalt/chromium levels for patients having these MOM devices.
Ed Larsen
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Hi Ed: I too had exactly the same situation as you. S & N BHR is 8/2008…only to undergo revision of the BHR in 8/2011 for metallosis….There are many people involved in this blog that had had revisions of their BHR’s…we need to get together in mass as there is power in numbers! I have spoken to 3 law firms that won’t touch the BHR because of the PMA approval process of the FDA…but if enough people come forward maybe we can do something about this.
Laurel Mengarelli
We need FDA to act on this based on the ground swell of problems occuring and info being generated so they revisit what they have approved so maybe we all potentially have some recourse
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Hi Ed (and Laurel): I had what I thought would be a BHR resurfacing back in 2009. My bone stock wasn’t good enough and so my BHR resurfacing was changed intraoperatively to what my hospital (in Oregon ) labeled as a BHR total hip arthroplasty, and they listed a BHR acetabular cup and a BHR Modular Head and Sleeve on my op. report. When I suddenly developed severe pain in my implant area, quickly spreading across my thigh and forced me to have revision surgery, but only after a ‘pool of fluid’ was seen on MRI around the MOM implant. That pseudotumor was found (only upon revision) to be Metalosis, and I lost a great deal of flesh (necrosis) and some bone. My point is that I had normal levels of Co/Cr in my blood, so if that is the only test given (let’s say to a MOM person who has been told to get same as a precaution), then many a pain-free MOM victim will assume after their test that they are not in danger. It also speaks to a greater concern: how many people who have this metal ‘bomb’ in their body are really out there? Thousands? More?
That fact is why I am afraid S&N’s ‘success’ figures are so skewed; they haven’t heard from so many who will inevitably begin to suffer. And this is why they will not recall the thing, because they ultimately will only have to deal/settle with those who have truly been poisoned. People who are told to have their blood tested who have a MOM should also ask for (demand) an MRI of the implant. Without the MRI my doctors were in no hurry to revise me. I was told to take a conservative, ‘wait and see’ approach.
But this MOM Iceberg will eventually come out of the water completely, and there now seems little doubt that if you were poisoned by them they will have to make you whole again, by whatever means. (There is a suit in Illinois Earl posted a short while back that I believe involved the BHR, and that attorney presents an interesting petition, but that may be in that US State only — try to find it here by clicking on November archives found on the left of the site — or ask Earl).
I have now discovered that the BHR Modular head was never approved for use in the US, and since I went beyond the BHR you both had I have a firm that is taking cases such as mine now as there is no longer a PMA to hide behind (S&N is so dirty they were telling surgeons they were using a matching BHR Head — not approved for use in the US)! So why didn’t my surgeon know that? Do the hospitals listen more intently to medical device reps than they do the FDA? For that matter, who is the FDA listening to?
At any rate, I am now working with one of the biggest, most successful law firms in this nation, and I don’t know where they currently stand on your PMA BHR product. You can easily find out by emailing (Ben) and asking him. He doesn’t advertise because he is too busy, but has told me to give his email to BHR people who have suffered through metalosis induced revisions. It’s worth a try, and the tide against S&N is truly turning, as Earl has lately been saying.
Good Luck!
Thanks. Interesting info regarding the BHR Modular head and lack of approval..That’s something all BHR patients should try to determine as to whether they may have this component implanted???
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