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American Academy of Orthopaedic Surgeons, Cobalt chrome, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, DePuy ASR™ XL Acetabular System, DePuy Hip Recall Litigation, DePuy Orthopaedics, Failure rate, FDA, Food & Drug Administration, Hip Replacement, hip replacement failure, hip revision, Medical device, Medicines and Healthcare products Regulatory Agency, metal, Metal on metal hip, metallosis, Nephew Smith, Orthopedic surgery, Smith & Nephew, Total Hip Replacement, UNited States
I just want to emphasize how important it is for as many of us as possible to send in our stories of our MoM nightmares to the FDA before May 9th for the hearing listed above. Those of us who are not in the recall groups have a long row to hoe, so all of you who are having problems with any MoM THA try and get the word out to these people. The more of us who reply the better, and I’m now thinking it doesn’t matter whether you live in the US or not, this being a world-wide problem. Wherever you are, if you come to this site and see this post, please try and join me in sending your story to the FDA before this hearing.
These device manufacturers need to be held accountable, and they’re doing their level best to ‘paper over’ the whole problem. No human should have to undergo multiple surgeries, with the revision(s) costs involved and the pain and suffering that goes along with it.
I hope everybody’s doing a little bit better right now, and if not try to keep on keepin’ on (that’s my situation after my revision this month on my MoM ThA, and the size of the pseudotumors that had to be excised, as the doctors like to say. Just a little excision, a little metal mixed in with your flesh around the implant, nothing to be concerned about. It’s because you’re one of the few who are just plain sensitive to metal ions. How many living beings are not ‘sensitive’ to metal ions leaching into their bodies with every step they take?
I think mainly the only people who aren’t ‘sensitive’ are those who aren’t that aware of their symptoms because they’re very old and aren’t totally ‘with it’ (I have such a relative with a MoM), or those who simply do not use the joint all that often. I have noticed almost all of the problems here and on other sites (excepting those sponsored by the pharmaceutical companies), and reported by MoM victims telling their horror stories are younger and consequently much more active people. I believe it is this demographic where failure rates are at least twice what’s been reported, as we are ‘pooled’ in with the much older MoM THA recipient to ‘thin’ out possibly alarming failure numbers. When some company like Smith and Nephew trot out there statistics of success, they therefore rely and recite numbers and percentages that are very skewed based on their ignoring the ages of those who have had problems.
We can turn this thing around only if we expose the FDA or MHRA or any other country’s medical regulative body to the undeniable truth of ruined and at the very least painful, diminished lives.
I’m just trying to keep the ball rolling toward our ultimate goal, that being the urgent and necessary recall of all MoM hips, which we the public deserve from the health agencies formed for our protection. I’m convinced we can eventually win the battle, but only if we work together and are tireless in our efforts.
Related articles
- June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (earlsview.com)
- Metal-on-Metal Hip Implants > Concerns about Metal-on-Metal Hip Implant Systems (earlsview.com)
- Researchers surprised by metal ion levels in 5-year follow-up of MoM THA implants (earlsview.com)
- Howard Sadwin’s Suffering from Metal-on-Metal Hip Implant | Mesh Medical Device Newsdesk (earlsview.com)
- FDA Will Review MoM Hip Safety – MedPage Today (drugstoresource.wordpress.com)
- Metals from hip replacements present toxic risk for millions, investigation warns (earlsview.com)
- Metal Hip Implant Concerns – Potentially Bigger Scandal Than Breast Implants (medicalnewstoday.com)
- What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs (earlsview.com)
- Howard shares more views (earlsview.com)
- Metal Hips in Britain Require Longer Monitoring, Regulators Say – NYTimes.com (earlsview.com)
hbs924 said:
Thanks Earl why is the truth so hard to deal with? Market Share, finances, rate of returns to the investor at all and any cost!!! I have read hundreds of stories of the horrors people are and will continue to go through, no matter which country the stories repeat almost verbatim the same symtons and complaints; from rashes, fevers,aches, pains, vision,energy, depression etc. etc. if you made up a check list MOM hip victems have almost identical comments as to conditions they are experiencing.
Howard Sadwin
Ray Zakarian said:
Where do I go to post my story?
brooks said:
It’s all in the notice posted 27 April 2012, but below is the relevant information for sending in your story (Sorry, I should have mentioned that in today’s post).
Food and Drug Administration
[Docket No. FDA-2012-N-0293]
Comments: FDA is opening a docket to allow for public comments to be submitted to the Agency on the issues before the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee beginning on [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER], and closing on May 9, 2012. Interested persons are encouraged to use the docket to submit electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
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