This is just an idea on how we might make it easier on those of us who want to report our MoM problems/failures by Tuesday next, because we only need to get on record with the FDA. I have read and agree with others here that we need to make the FDA realize all MoM metal on metal hip designs are not safe. I don’t know if you’ve written about your plight yet, but if it’s posted on Earl’s blog, all you have to do is copy and paste the important or salient points from what you put up on the site to another document and edit it a bit. Plus I hope most people have their surgery and revision records from your hospitals, and if not, all you have to in the US is call the records department. I have my most recent ‘Hospital Course’ and ‘Procedure’ from my revision, plus my original ‘Operation Record’ from 2009 when they put this thing in and a short summary of what happened to me. (The pages I sent list all of the parts that failed and led to the premature revision). Our hospital records are golden, and sending the important ones in might lend more credibility to our short stories since it’s on their letterhead. It might also be all they’ll see at the FDA, because I don’t think they care to read tragedy. Marketing letters and brochures they apparently glance at as they fly across their desks, hence this charade of an approval process that allows MoM use.
So I’m thinking short our stories should likely be. I deliberately left out the word ‘consequences’ above, because we all know our governments and their evident incompetence won’t allow them time to read much of how our lives have been ruined. They couldn’t care any less about the humans they’ve experimented on. These people need to see numbers, and as many as we can get. Only when products are finally recalled are we in a good position to be treated at least fairly, by whatever regulatory agency governs our countries. Like Depuy, for instance, you’ll remember it took a while for them to recall their medical devices, but all of the poisonous hip products ‘installed’ have to go. And I just feel I need to do what I can to get them tossed in the can for good. They are a terrible, horrific thing, and from my recent personal experience (last revision in April) I can now also say unequivocally that the even that wondrous alloy Oxinium, while admittedly harder than Titanium, creates the same pseudotumors (metalosis) in the tissues around the implant area. Mine were 8 by 4 by 3cm and 4 by 4 by 3cm, respectively. So while this oxidized zirconium maybe helps a little, it is far from perfect, but my happy doctor told me how routine and easily those two round masses were simply and easily ‘excised’ during revision (we just cut them out, it was no big deal. Your revision went very well. While I know my doc means well, my point is I shouldn’t be undergoing a revision at all yet). Am I supposed to yell out “Great work”! Thanks to you highly trained men, who let medical reps take you out for entertainment and got you good doctors to buy their latest wares. New products keep coming, and as Howard has said, we are the guinea pigs and so just a few of us have been damaged and disabled, or so goes the story line. Compared to the vast group of humans it is helping, they are saying, we really don’t matter! It’s all in the numbers, and I would wager that if demographics were allowed, where a fifty-five year old athletic person would be separated form seventy to ninety year old hip recipients, we would see a startling failure rate among the younger, more muscular people than we would on those whose activities are limited to bingo. And yes, I’m thinking they quote from the bingo ‘pool’ numbers, to make it appear as if their ‘biocompatible’ devices were working well for a vast majority of the populace.
So my Smith and Nephew failed in three years due to metal on metal abrasion, though it is advertised as much more resistant to wear (“Yes there was still a little less ‘metal debris’ after it had been on the hip simulator for 1000 cycles! No harm there)! Fantastic! There is less! Less won’t bother our human customers as much! DOCTOR: I’ll order 1000 today! I am sold on this new stuff. (It’s expensive, so the surgeons call it “Black Gold” over here, and there’s probably quite a bit of profit margin for the salesman of that black junk. Plus with all of the revisions, they get to sell them over and over! Those reps can make as much or more than the surgeons they hand pieces to in the operating room. Yes, for those who weren’t aware, your medical device salesman is in on every THA, TKA, UKA, TSA, TAA, TEA, or ‘resurfacing device’, standing right next to his good friend your surgeon. (The acronyms above refer, in order, to total replacement of your hip, knee, half your knee, shoulder, ankle and shoulder. While I don’t blame my surgeon, he sure didn’t do much to help me. Those device reps must be good. one surgeon I met said I could benefit from a new meatel shoulder — I will never do it, as I’m in worse pain in every joint I have had replaced. Tell people they should never allow anyone to put metal in them, unless it to replace a joint that was completely destroyed as in a violent accident. I always tell people my horror stories, because mine have stretched over ten years now. I wish I could travel around and tell large groups of people about it, but if we all talk about it we’ll get a similar result; let people know, everywhere you go. I guess I’m alittle obsessed right now, but I am extremely pissed off and that’s why I need to let off steam. Finding this site has provided great relief for me.
But I digress. To summarize, don’t summarize at length as I did here, because I passed the ‘summary sign’ way back there. But if you can, send something in, even one or two pages. I’m still venting right now, so what I wrote here is way too long, as usual, but especially long for the FDA. But there has to be justice here, and there will be, because metal and flesh do not mix well together, and any device that fails in a few years and damages the person it were supposed to help cannot be labeled a ‘good’ device. The word ‘good’ doesn’t seem to work that well in describing something unsuccessful. Something that doesn’t come with a warranty, that you have to pay for at least twice (And pain and suffering are one of several kinds of payment we have all made), and rehab from the whole thing again.
I Hope everyone who reads this gets better