DePuy, FDA, Food & Drug Administration, Hip Replacement, Johnson, New York City, Thursday, U.S. Food & Drug Administration, U.S. Food and Drug Administration FDA, UNited States
FDA Considers Metal Hip Injuries — A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts.
FDA Considers Metal Hip Injuries — A Bit Too Late for Some Victims
The U.S. Food and Drug Administration (FDA) will hold a gathering of scientific and clinical experts to discuss whether metal-on-metal (MoM) artificial hip systems should undergo more rigorous scientific scrutiny before they are implanted in U.S. patients, which sounds infinitely reasonable.
On Thursday, March 29, the FDA announced the meeting will be held June 27-28. Although the meeting site is to be determined, anyone interested should contactAvena.email@example.com or .
The expert panel will discuss the available scientific data on metal hip implants regardless of whether it’s the total hip replacement or a resurfacing procedure, and whether they should be subjected to the same sort of premarket scrutiny for safety and efficacy as drugs.
Unlike pharmaceuticals, medical device makers enjoy a hands-off approach to regulation. Complications that arise in an undetermined number of patients are investigated after they’ve done their damage. I continue to believe if the public understood the Wild West approach the FDA takes to some of these dangerous devices, there would be outrage. Those who draw the short straw and experience complications understand what’s happening after the fact.
Howard Sadwin is one of those people. Our client, Sadwin, 65, of Sarasota, Florida, received the Birmingham Hip Resurfacing System (BHR) made by Smith and Nephew in 2007. The company says resurfacing is a bone conserving procedure that is ideal for the active patient. Howard was very active, training his Labrador retrievers, hunting, and playing with a young grandson. Now he is in a wheelchair. By 2010, his MoM hip had dislocated three times and had to be removed. The surgeons found so much infection and fluid in his body that they told Mr. Sadwin that he was dying. He spent 10 months in the hospital with doctors cutting out infection and a portion of his femur. He went 16 months with no right hip at all.
A recent BBC/ British Medical Journalinvestigation looked into Smith & Nephew as well as Johnson & Johnson and Zimmer Holdings, all manufacturers of MoM hips, and found some patients develop an immune and inflammatory response to metal hips which is likely related to debris from the metal ions which leach into the bloodstream.Preview
About 500,000 patients in the U.S. have all-metal hips but we don’t know the complication rate, because unlike the UK, we don’t monitor such things here. You have a better chance of receiving a notice about your recalled defective Toyota than your hip implant.
It’s a crazy, mixed-up system that is putting countless patients at risk.
Back to the FDA. The purpose of the meeting is to get practitioner input on metal-on-metal total hip replacement systems as well as the metal-on-metal resurfacing systems.
To be considered:
- Failure rate and modes
- Metal ion testing
- Imagine methods
- Local and systemic complications
- Patient risk factors
- And consideration for follow-up post surgery
I hope those in attendance are ready to listen to Howard who would love to share his tragic story with the panelists leaving no doubt that this was a preventable outcome if the FDA had been doing its job as responsible and hands-on regulators. Howard has also been in touch through his blog and internet research with patients from around the world who have similar tales of pain and suffering attributable to metal-on-metal implants.
- FDA panel sees little use for metal-on-metal hips – SFGate (earlsview.com)
- J&J Sold Transvaginal Mesh Implants After FDA Ordered Company To Cease Marketing – SFGate (earlsview.com)
- Johnson & Johnson Violated FDA Order to Halt Sales of Transvaginal Mesh (prweb.com)
- FiDA Failed Implant Device Alliance (earlsview.com)
- FDA looks the other way while school uses electroshock torture on autistic students (sgtreport.com)
- Prominent Metal-on-Metal Hip Implant Attorney Dismayed by Statements from DePuy Orthopaedics Official Regarding Evaluation of Metal-on-Metal Hip Replacements (prweb.com)
- Rottenstein Law Group Alarmed but Not Surprised by Number of Hip Implant Complaints to FDA in Past Decade (prweb.com)
- Medical Device ” The Senate Passes Unparalleled Medical Device User Fee Act (earlsview.com)
- FDA Meeting: Do Food Dyes Cause Hyperactivity? (caringdoula.wordpress.com)
- Actelion Pharmaceuticals Announces U.S. Food and Drug Administration Approval of Supplemental New Drug Application for Second Generation VELETRI(R) (epoprostenol) for Injection (sys-con.com)
The article is great and quite true. I had the honor and privledge to speak to this panel along with others. There were scientist, surgeons, doctors, PHD’s, nurses, and lay person on the panel, the panel listened very carefully, they paid attention to the video and power point presentations and we were there in the flesh, they witnessed some of our dissabilities and difficulties.
The media, journalist, attorneys, manufacturers “commentors” ( they were extremely smart sounding. The presentations became to technical for me to understand, however, I heard there was no use for these MOM hips, the market will provide significant numbers to demonstrate when first introduced to our country as with my friends from NZ,UK,AZ etc There were reportedly 500,000 people implamnted with metal on metal (MOM ) hips including resurfacing in the US alone, today probably less than 1% of new hips are metal on metal (chromium/cobalt materials)
McMinn was even there the partial inventor of the BHR.
How the panel will deal with the discussions is a question we all anxiously awaity.
If you have a metal on metal implant or resurfacing device also metal on metal it may be advisable to talk to your surgeon about 12 month MRI and blood work to determine chromium/cobalt levels. again at 24 months every year.
Had I or my doctors known anything abut my symptoms and those 1000’s of other victims, maybe things would have been better for us, but they were not WHY because the data wasn’t there and or the manufacturers stretched this out as long as they can.
The manufacturers hope for preemption, limited liability, crazy time limits on statutes of limitation, when did you 1st become aware of your problem ???
Facts are coming out every day, stop using MOM implants is the call from all over the world including the USA. If 500,000 were put in what is the known adverse event reported of late, seem to be rising with each day.
there were folks I met that came just to support friends reporting to the panel including a great guy I met, who is going through a horric experience with his hips and revisions etc, he drove 6-8 hours to support a friend that spoke to the panel. I met some pretty special people, I was proud to speak along side of them, on June 27th or anytime any place.
I made mention the best way to resolve this debacle, hire an ” Elliot Ness ” he or she or they report to the VP. Secretary of State, or President with no obstacles and the corruption in the medical device world is eliminated or under controll. Finning these manufacturers doesn’t work they are repeat offenders of paying kickbacks in order to market their devices, perhaps kickbacks paid to get approval of their devices , or paid to hold back on information it goes on and on, it must end if the public is to show respect to the medical world. More importantly, I for one would have more respect for my Government for protecting my well being and quality of life first rather the way it appears today.
This needs to be done now, the longer we wait the more people will suffer. Taking my time table from implant in 2007, nightmares began 10-11 monthes post operation, dislocation 3 in 2010 and removal of MOM hip leaving me in a wheelchair with very liittle walking ability etc.
You can draw your own conclussions, whatever you do if you have a MOM hip have it checked out properly- there are some of these devices working fine TODAY, tomorrow could be different, don’t end up like me.
I flew to Washington, DC on June 26th, 2012, spoke to the panel on June 27th 2012,
the following day when I awoke I felt better internally than I have in too many years,
Life is about giving back, and that is the feeling I want to share and I want it to spread.
Thanks again to Earl for providing this great highway of information.
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