Tags
blood test, DePuy, Femur head, Food & Drug Administration, hip resurfacing, pain, Patient, Stryker
Legal help sought – Cormet Hip -Isn’t there some way to get beyond PMA preemptive device approval?
Like so many others, I bought the dream of a reinvigorated lifestyle and a return to activities that I valued. “You’re young and fit, a prime candidate for resurfacing. I have patients that are running marathons and skiing within 4 months.” In go a couple of Cormet Cups and so starts the decline.
Within 2 months the pain starts to and is attributed to the 2% of patients that get heterotopic ossification. So chalk that up to fate and move on.
Within 4 months the pain is so sharp that I can’t put weight on the left leg and within a week the femoral head has snapped. That puts me in the 1% group so now I am 1% of 2%. In goes a full revision, but let’s make sure that one is fully metal too, this time make it a Stryker please.
The pain continues, strength plateaus then maybe even declines and the surgeon tells me I am ready for soccer. I tell him I am not, and he says that I am ready for yoga. On my nth visit apparently he has done some reading because, though I was supposed to be ready for soccer, it is now time for a blood test. The folks in the lab tell me that I am the third ion test that this particular surgeon has ordered today…..hmmmm, something has changed. Both readings (Chromium and Cobalt) are over 7 and the surgeon tells me I have a problem that only 3% of patients develop. So now I am in a select group of patients that can claim to be 3% of 1% of 2%.
For the curious among us, that puts me at the 0.0006% mark meaning that of 1,000,000 people to get hip resurfacing only 6 will develop this set of conditions. Now I don’t think that there have been that many resurfacings yet (despite the effectiveness of the marketing videos and doctor’s pitches) so I am truly very special.
But I don’t feel special. I feel rotten. And I am angry because everyone got what they wanted except for me…….the guy who paid for all of this work and endured the recovery, the fractures, the pain and the revisions (now on my 2nd and about to go for my 3rd).
And now, after speaking with over 10 legal firms, no one is willing to take this case because Cormet has PMA from the FDA. They crossed a bridge that keeps them safe and no legal firm sees it to be worth their while to take this on when there are DePuy suits to be filed that are so much easier.
I know that I am not alone, that there are many others who are suffering much worse than I am. I do not mean to whine and in fact am keeping my chin up. But there must be other Cormet sufferers out there? Is there some legal group willing to help us to reclaim some bit of our original expectations? This just ain’t right.
Email: jack.petropoulos@gmail.com
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Earl's View 
Jack, you are not alone, as many of us are not YET recalled and S$N’s BHR was PMA’d through the FDA (I am a revised, metalosis/pseudotumor/necrosis BHR THA victim). We must be patient, because we aren’t that low-hanging Depuy fruit.
I have lately seen a significant change in attorneys in the US, and just last night a TV commercial said any metal-on-metal hip sufferers should call such and such law firm immediately. (The web attorney sites now talk to any metal person. An attorney told me that ALL MoM hip implants will be eventually be recalled.
The truth will out in this horrible tale from hospital hell, and our voices will be heard.
Let’s try to live in this moment and keep on keepin’ on. I personally have no other choice, and must refrain from obsessing on some degree of justice (including compensation for multiple surgeries, pain and suffering, etc.). I am now relegated to just letting it happen, if for n other reason than peace of mind.
The more we post here the more this story grows, and the closer comes it’s resolution.
Another victim of CORMET. Just had a hip revision. Metal ion levels (cobalt/chromium) 60, 10 x upper limit of normal. Lawyer dropped my case as Jack described. The reason why the failure rate is low is because metal ions are not being routinely tested as claimed AND Patient Registries are not in place to monitor safety. I KNOW, I WORK IN CLINICAL RESEARCH! Damn. I should have know better, I was basically a guinea pig in CORMET’s large clinical trial to prove there system is not better than the rest. I will not give up to CORMET pays.
Hi David
Seems these medical device companies are Teflon. Screw up our lives and no consequences.
Earl
Pingback: FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew « Earl's View
I have just found out today that my chromium and cobalt levels are through the roof. I am waiting on more tests to find the outcome. My resurfacing was done 2 1/2 years ago and my doctor has known my results for 6 moths without letting me know. I don’t know what is in store for me in the future but very very concerned.
Hi Susan, that is criminal. Are you going to sue him? There is so much information available on the toxic impact of these metals that he has no adequate defense to have withheld the information. The levels will be even higher after this length of time.
So many things going through my head. Don’t know yet what I will do. I will know more at the end of the week.
Thanks for your support.
Sounds like a clear case of professional negligence but I am not a lawyer. But still cold comfort for you. If my revision is anything to go by the relief will be immediate and recovery better than the first time round. Here’s hoping.
Pingback: All the Reasons WHY Smith & Nephew Birmingham Hip Resurfacing Should NOT have gotten PMA from the FDA « Earl's View
Pingback: Smith & Nephew – BHR PMA – FIRST OF A KIND PMA – WHO PULLED WHAT STRINGS???? « Earl's View
Pingback: Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for safety, efficacy and improvement in health outcomes for patients as an alternative to total hip arthroplasty « Earl's View
I have had my revision surgery 4 wks ago and recovery is very good. I have seen a solicitor who is very confident for reimbursement for pain and suffering etc. He says they have known about metal on metal prothesis problems for a couple of years now and should not be using them. I saw my surgeon today and he said he used to do 80/year of these Corin resurfacings and now is down to 5/year. What does that say! I live in Aust so it will be interesting to see how this claim pans out.
New research coming out today suggesting more failures that are asymptotic and MoM should be must be imaged to detect as the failure rate is growing. Check out this short article about upcoming research for Hospital for Special Surgery
http://www.healio.com/orthopedics/imaging/news/online/%7BED4A6D54-132F-4B8B-89EA-BA4B0A8BDC7E%7D/Study-MRI-predicts-failure-in-MoM-hips-by-identifying-tissue-damage
My sister and myself have been infected with this Cormet MOM hip. My sister will have surgery Tuesday 6/25/13 for revision surgery, I will have to wait until 2014, since I have used all but one week of my FMLA at work.
What upsets me most about our predicament is that our surgeon failed to disclose all of the possible complications with MOM. The only concern that he told us that we should have is that we might have an allergic reaction to the metal, as if we would know within a few days or weeks of surgery if we were allergic.
I have read all the comments and I am wondering if anyone has sued successfully???????
Wasn’t the Cormet device approved via the FDA’s abbreviated premarket review for class III medical devices. I think it means that not testing was done prior to approval because it was a version of a near-like product already on the market. Therefore, the did not have to prove safety or provide supporting data. In 2007 when the device was approved, I believe a full premarket review should have been required by FDA. Looking at the agency’s PMR, if a product is manufactured to be different to any significant degree, the full PMR is required. I suggest that the resurfacing system was such a change, other wise there would not be a new ‘system’. Not testing the new system and presenting it to the FDA as a ‘near same’ product was perhaps misleading. Consequently the protection under the umbrella of the PMA may be arguable if no testing or safety analysis was included in their 30-day PMR application.
Curios if anyone was successful with any compensation from Cormet. My husband had the Cormet and then was lucky enough to receive the ABG ll from Stryker which required 3rd revision. By this time he has lost 1/3 of muscle, is deaf I one ear and who knows what else with long term metalosis because he was never notified of the recall.
Holy Hannah, these stories doe not sound very encouraging. I have a 12 year old hip (Corin, Medical Trial in Boise Idaho 2005) and am having it yanked out Sept 8 2017, in 2 weeks or so. Have there been any legal developments against Corin Group? I am a Canadian Citizen and not sure if this changes the equation and permits me to persue under Canadian law even though surgery was in the US.
Is everyone in the America who as commented on jacks post? I live in the U.K. And had 2 corin cormet hips one of which needed revising 2 years later by which time I was in agony. 6 weeks after the revision (my healing was slow) I had a stroke and I swear it was because my metal ion levels where through the roof! My second one was revised in 2015 because even though they had removed the painful hip my metal ions where still through the roof.
Sad too say that I hear everyone’s pain and aggravation. I am also a victim of the Cormet BHR. In 2008 I had my initial surgery and came out of it like an all-star. I returned to life and was fully active. In Aug. 2015 it all changed, I was playing golf when suddenly heard a loud crack as did my foresome, I took a few steps with great pain and plenty of awkward sounds coming from my hip, long story short I was hobbled from that moment on. I had Xrays that looked great and was prescribed pain meds and told to take it easy, For months I limped in agony to the point I needed a cane (56 yo & healthy). 2016 rolled around and I was fit for a straight jacket in pain, I had blood-work that showed only slight levels of metal 6.75 & & 7.00, told we would need to check again in a year. At this point I had a MRI and was told to see a Metal Revision specialist and when I finally got an appointment my leg had become 2″ shorter and PAIN was still beyond words. The specialist took xrays and after reviewing told me that I must have the highest threshold of pain he had ever seen, as he said “your walking on a broken leg, your Femur head has snapped off.” hence the short leg.
Upon revision surgery and though my metal numbers were barley elevated he told me that he had to remove 60% of my hip muscle due to necrosis.
I have had to be taken by ambulance for 4 subsequent anterior dislocations as I don’t have the tissue or muscle to hold the hip in…… Yet Cormet goes on its merry way.
I have made one attempt at a claim which the attorney dropped sighting they ere never Cormet devices were FDA approved and never recalled.
——-We Need More Voices to be heard——- And a pit-bull to go after them
Be well fellow victims
Tom
ttriba@yahoo.com
Tom
So sorry to hear about your nightmare. I hope you get some relief somehow.
Earl
Earl,
Thank you, I appreciate letting of some steam. Wishing you a Merry Christmas
Tom