Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements.
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Thursday, May 17, 2012

Congress Fast Tracking Medical Device Implant Harm

LINK    to KGO TV video

A medical bill, getting fast tracked through Congress, is short changing the safety of patients. That's according to a watchdog group in Washington. The bill moving though the House and the Senate is pretty routine; it involves industry fees paid to the Food and Drug Administration for testing. But inside the bill there is a provision involving medical implants that the non-profit consumer watchdog group, Public Citizen, is calling dangerous.
Richard Carpenter of Danville walks with a slight limp from his 2011 hip replacement.

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"It was brutal, it really was," said Carpenter.
It's taken him a year to recover and he says he can't run.
"No, no. If... all I can say is if something happened and I had to run away from an emergency, I'd be that first person that they find closest to the emergency," said Carpenter.
The former fire marshal of Contra Costa County laughed at that joke a bit, but it's been devastating. He can't work, can't ride a bike, and it didn't have to happen. He got his first hip replacement back in 2008. In Carpenter's case, the hip he got in 2008 was metal on metal and after a little more than a year, the artificial joint started shedding metal savings into his leg.
"And it got into my abductor muscle, the muscle on the outside of my leg, and they had to remove 10 percent of my abductor muscle," and Carpenter.
And doctors had to replace the metal hip, just three years after they'd put it in. Carpenter says he only found out afterwards that the first hip hadn't been thoroughly tested.
"It's a device that goes in your body and it just shocked me that there was very little testing done at the time," and Carpenter.
And in Congress there is a new bill that a major consumer group says will continue that lack of oversight.
"And it doesn't involve any testing in clinical trials or clinical studies in human patients to prove that it's safe and effective," and Michael Carome, M.D., from the Public Citizen's Health Research Group.
Carome says Congress is fast tracking FDA approval of medical devices as long as they resemble devices that have already been approved, even if the original devices have been recalled for safety defects.
"Which means, under the current law because of the dangerous loophole, another manufacturer could design a very similar metal on metal hip implant, and the FDA would have to clear that device, if it was found to be similar," said Carome.
It makes no sense to Carpenter.
"If they're not going through the approval, they're taking the same chances I took and what happened to me, and I wouldn't wish that on anybody," said Carpenter.
ABC7 News called the company and the Medical Device Manufacturing Association, but neither one returned our calls. The House version of the bill, HR 5651, just passed unanimously out of the House Energy and Commerce Committee. The Public Citizen's report on the bill can be found online.
(Copyright ©2012 KGO-TV/DT. All Rights Reserved.)

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