American Academy of Orthopaedic Surgeons, Cobalt chrome, Cobalt poisoning, DePuy Orthopaedics, Femur head, Food & Drug Administration, Hip Replacement, hip replacement failure, hip revision, knee replacement, Medical device, metal ions, Metal on metal hip, metallosis, MoM Hips, surgery, Total Hip Replacement, UNited States
I thought it might be helpful to show what I sent in electronically in advance of the above referenced meeting, (the specifics of which have been posted on Earl’s View before). I do this in the hope that more people will consider sending in their very similar stories to this committee, as I have learned today through conversation with the FDA that the comment window will be open through August. This certainly provides more time, and below is simply an brief explanation of what I have endured. If anyone wants more information they can call the FDA at 301-827-6860 for more specific instructions. I have also listed the email location, docket number, etc. in comments and replies to questions previously on the site here. If anyone is interested and cannot find that information, just leave a reply and I will provide it. (The Docket number that must be on your submission is also listed on the copy of my letter below). The FDA number I found today is probably the best way to proceed, to ensure your message is seen by the people that are supposed to see it (and no one else). I truly believe they will be examined and tallied, as this MoM nightmare is growing larger day by day, and our task is to make sure we are counted among those who are and have suffered because of these devices, we who were injured more by the very ‘solutions’ than we were helped. I sent mine in because I feel it is how i can best help our cause right now.
At any rate you will see that I notify the FDA in the body of text to follow that “I have attached three files that provided sufficient detail the premature failure of my Smith and Nephew metal on metal hip implant, and the recent revision necessitated by its’ faulty design“. While two of those files show ‘snapshots’ of my original THA surgery in March of 2009 and my revision in April 2012 , both of them were simply copies I’d obtained from the hospital. Both provided summaries of my procedures, the ‘products’ that were ‘installed’ in me, with the record on the revision procedure covering well my pseudotumor (metalosis) removal, necrosis that filled the underside of the hollow metal femoral ball, etc. I am not posting those hospital records for public viewing here, as they were specifically intended for the eyes of the FDA convened panel. I sent in one additional Word file listing the relevant part and serial numbers of the recently explanted Smith and Nephew devices (in my possession) that I will cut and paste here:
Explanted Smith and Nephew BHR Acetabular Cup:
C 58 MM
Explanted Smith and Nephew CO/CR Modular Femoral Head:
C 52 MM (No other identifying numbers visible on component)
Below then is just an example of what anyone can do, especially if you are in the US. I would ask that even if you are not, but have similarly suffered at the hands of Mr. Smith and his Nephew or any other manufacturer (recalled or not) to please submit your stories as well. The more of us that speak up and are heard from, the closer we are to seeing some movement from the regulatory boards that are here to protect us. Here’s a copy of the message I sent:
Document ID:FDA-2012-N-0033 Document Type: Public Submission
This is a comment on : Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Docket ID: FDA-2012-N-0293
Dear Sir: I have attached three files that detail the premature failure of my Smith and Nephew metal on metal Hip implant, and the recent revision necessitated by its faulty design. The metal ions released from the metal on metal articulation of my Smith and Nephew BHR THR device poisoned my flesh, and created pseudotomors (Metalosis), foreign masses that had to be excised after the failed MoM hip was explanted. The details of this are found in the attached documents, and the Smith and Nephew BHR THR I received in March 2009 did not last three years. I received it when I was 55, and I am a very strong man. I have never experienced such pain as with this original device failure and the revision it required, my MoM THA being recently replaced on April 2nd, 2012. As an agency the public created to protect them from harm inflicted by such devices as this MoM, you have failed greatly in your task; you have not protected us from harm, and in fact have allowed our bodies to be used as a ‘test lab’ for the device manufacturers. We are human beings, not guinea pigs. I further submit that age and human strength must be factored into any success and/or failure numbers such as those provided by Smith and Nephew, because it is our younger demographic who actually tax these devices and subject them to heavier loading, as our bodies (and these devices) are simply utilized more than by us. A seventy or eighty year old does not make the same demands of an artificial joint. Demographics are an important factor and must be taken into consideration when looking at the success or failure rate associated with this Smith and Nephew MoM Hip Implant. Please see the attached files to receive more specifics of my device, as well as part and serial numbers and specific Smith and Nephew model numbers.
So that’s all it takes. If you do choose to submit your story — and it can be on any device because it is MoM hips in general that should all be banned — carefully observe that your comment will be displayed publicly unless you indicate that you do not want it to be seen by all. I made this mistake myself and had the FDA take down that mistaken (my mistake) public posting of my piece. They informed me that a copy would still be held by the FDA for the Device Panel’s review, satisfying my primary objective. That FDA number again is 301-827-6860, if you have questions or need help on this. This is one way we can take action for the next few months, that our voices might be heard. I agree with Howard when he says that eventually they will hear us, that the truth will out! I will not think otherwise, as these injustices simply cannot stand.