FDA, Food & Drug Administration, Hip Replacement, hip resurfacing, Magnetic resonance imaging, Nephew Smith, Smith, UNited States
I too am living in BHR MOM hell at present, and I am awaiting results on trace metal levels as well as a scheduled MRI. I plan to file a full report here when I have all of the data. For the record, I am fifty eight years old but have been an athlete all of my life, am still in relatively good shape and am very limber. From what I hear and read, it seems that when the FHA says only a small percentage of patients have trouble with the revolutionary “Oxinium” MOM BHR, they are talking about younger, historically active people who still have good musculature and flexibility. My mother had no problems with her MOM hip, because her exercise was limited to driving to the market and playing cards — she is representative of the majority of patients who have no problems. As I have told my doctor, “use equals pain” — my mother (and many other seventy and eighty year olds) are predominantly sedentary, hence their inclusion in the statistically ‘successful’ majority.
I’m in the states, and my co-pay is 20% (after a 500.00 deductible), so my THA did not come cheap — when it was ‘installed’ in in March of 2009 by my local ‘Bonesmith’. (Yes, that is quite simply what they are, and we are their ‘bonestock’ — nothing more). I was told last week (Jan. 26) I needed a revision ASAP, and that gosh darn it, some people are just ‘hypersensitive’ to a metal on metal prosthesis (Why didn’t I hear such possibilities before my surgery in 2009)? This craftsman was adamant at immediate revision, and I had to request the MRI to be sure. It’s as if this orthopod knew full well what I was experiencing, and it took five minutes of consultation — I listened, he talked — before he wanted to schedule a revision. Unlike you, I still have insurance, but am now disabled and can ill afford another THA, and my share will run into the thousands — just under three years later!. (My co-pay for physical therapy alone totaled around $2500.00 these past few years). In short, this could very well break what’s left of the dilapidated bank.
One thing I came across in my fastidious — OK, obsessive — internet research was the following legal advice, and I paraphrase: “A study found that only a fraction of recalled medical devices had been approved through the more stringent pre-market approval process, or PMA, which is used for devices with a higher risk factor. The FDA 510k process is much easier for the device peddlers, as a company seeking FDA approval merely stipulates that the device, (and I’m reading from 510k summary # K083566 sent to the FDA by a Nicholas Tabrizi of Smith and Nephew) in this case the ‘R3 Constained Liners’ were “similar to the following commercially available devices regarding design features, overall indications, materials, sterilization and manufacturing”:
1. Osteonics Constrained Acetabular Insert (Submission #P960047)
2. Smith and Nephew REFLECTION Constrained Liner (Submission # K021803)
3. Smith and nephew Global Bipolar System (#K03743)
Under ‘Summary of Technological Comparison’ we read “The intended use, design, and materials of the R3 Constrained Liners are substantially equivalent to the previously cleared” […] Liners. Design Control Activities (“See…it’s just like those other ones… trust us”) have been completed and the results indicated (to S&N of course) that the subject device is safe and effective”. Ah, I’m reassured — the screaming pain in my hip is at least safe, and has been very effective in tormenting me! The FDA just ‘rubber stamps’ this stuff — astounding! Big Pharma has a huge lobbying influence in our oligarchy, whereas we (the guinea pigs) have no voice. It’s dollars vs. democracy, and we can see who is winning.
But here’s the possible opening for us: ‘If harm is alleged by a device that was endorsed under the more rigorous PMA process, the patient cannot file a lawsuit under state law” (The PMA process requires extensive clinical testing and inspections) “Yet if a device was not reviewed under PMA, but rather the 510k” (trust us, it’s just like those other ones we made), “a patient can file a state lawsuit”.
Short of a recall and subsequent ‘class action’, it seems this is our only hope.
I will post my entire ordeal later, as I said somewhere back there, but I saw your comment about the slipshod 510k FDA approval process and just had to comment here.
- Howard View – on a few things (earlsview.com)
- Mark’s Story – another Smith & Nephew BHR disaster – 18 Months (earlsview.com)
- John’s Story – More Smith & Nephew BHR Misery @ 39 years old (earlsview.com)
- UK hospital recalls all Smith & Nephew Birmingham Hip Resurfacing Patients… (earlsview.com)
- Harold’s Story – Smith & Nephew BHR – Pain & Tumour – Revision… (earlsview.com)
- More Smith & Nephew BHR Problems (earlsview.com)
- More Hocus Pocus around the Smith & Nephew BHR Metallosis Problems (earlsview.com)
- Kiwis told of implant poison risk – Metal on Metal (earlsview.com)
- Alison’s story – BHR’s don’t work for petite women – read on… (earlsview.com)
- Bryan’s Story – 28 Years Old, Two Hip Replacements – One dud Smith & Nephew BHR (earlsview.com)
katie kingsley said:
Thank you for your thoughtful and well researched response. I do have one question: In your last paragraph you state that there is recourse under the 510K and use quotes. Where did you get this information from? I have had two attorneys tell me otherwise but have not yet begun the process of researching this myself.
I am almost 3 weeks post-op from my revision and its been a bit of a bumpy road. I guess this is to be expected. I went into the surgery in the worst shape of my life. I wasn’t carrying any extra weight but my muscles had pretty much atrophied. As you said, exercise only causes more pain. So, I did my best to stop moving altogether. On a more positive note, the overall recovery for THR has been far smoother than the BHR. For me this confirms my gut feeling the BHR was never right from the beginning and that I never fully recovered from the surgery. My new surgeon confirmed post-op that the cup had in fact gouged the femoral neck and that it was thin and prone to fracture. Yes, the BHR, even though “small” was far too big for my frame. He also said that he had had to remove a lot of bone because the one thing the BHR did that it was supposed to do was allow the bone to grow in and anchor the device. I didn’t have a lot of bone to begin with and now there is some concern that a future revision will be very complicated at best. I am worried about this because I am not yet 40. Odds are, even if I baby this hip I will need another revision by the time I am 70. I just don’t know if I have it in me to go through this again. I lost a lot of blood in surgery and it has really taken a lot out of me. I thought I was tough but my body feels like its been pushed to its limit.
I am interested to see what your test results reveal and I would be willing to put my money down on the results. Have you scheduled your THR with “Mr. Bonesmith” or are you going to get a second opinion first? I do hope you are able to get it out very soon. For me, knowing that their was something foreign in my body that was purposefully placed there and was now causing me pain and sickness was the hardest part of all. I just wanted it out and NOW!
Thanks again for sharing this information,
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Sorry I missed your reply, Katie, I was new and didn’t have my email set up to notify me of comments and I just stumbled upon it. Here is the page where I found the information about PMA vs. 510k. I have no idea how much weight it carries, as I have yet to wade fully into the legal arena. The only thing I am certain of is that we are all being poisoned by these things and I am so sorry to hear of your plight. I hope your recovery has progressed well for you, and I hope you have more legal assistance now as well.
I just had my revision of my BHR THA last month, and have had problems, and can confirm they found metalosis in the form of pseudotumors all around the failed MoM implant. I got less than three years.
BTW — I don’t know why i was listed as anonymous on this response but have figured things out since then and now have a name. Again, my apologies for the delayed reply.