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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Tuesday, June 26, 2012

J&J ignores FDA rules: women outraged!




J&J Sold Vaginal Mesh Implant After Sales Halt Ordered LINK
By David Voreacos and Alex Nussbaum on June 26, 2012  Bloomberg News
Manufacturers including J&J sold about $175 million worth of prolapse mesh worldwide and another $295 million for incontinence treatments in 2010, C.R. Bard executives estimated on a conference call that year. Even for top sellers of the devices, the products made up no more than 2 percent of company sales, said Michael Matson, a Mizuho Securities USA analyst in New York.
The numbers declined as lawsuits were filed, he said in a phone interview.
“The doctors aren’t implanting them,” Matson said. “The patients don’t want them.”
On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices, Johnson said. The company will not withdraw the Prolift before its “planned discontinuation” of the mesh products over the next three to nine months, he said.
“Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics,” he said.
16 Questions
In letters to state and federal judges, the company said that it will update labeling for one device, the Gynemesh, to allow only abdominal, not vaginal, insertion.
The FDA learned of the Prolift after J&J cited it in an application to sell a related device, the Prolift+M, Liscinsky said. The agency told J&J to file for the Prolift as well, and it combined the review for both devices before the August 2007 letter.
“Due to the complexity of this procedure and potential high risk for organ perforation, bench testing is not sufficient to demonstrate device safety and efficacy,” the FDA said in the letter. Bench testing refers to laboratory testing to determine how a device will function in a person.
In the August 2007 letter, the FDA asked 16 questions about the Gynemesh and Prolift, which are made of the same nonabsorbable polymer. The Prolift kit includes pre-shaped mesh and instruments to help surgeons implant the device.
Infection, Abscess
One FDA query was about a “significant number” of complications from 2004 to 2007 on the earlier device, the Gynemesh. The agency got 174 such reports, including for infection, abscess and organ perforation. Most of the cases required additional surgery.
The agency’s letter also found that labeling for the Prolift+M device was deficient because it couldn’t support claims that the mesh has “elastic properties that allow adaptation to physiological stresses.” In its response, J&J agreed to remove that claim.
Many of the documents unsealed last month include e-mails between J&J and the FDA over the wording of product labeling about the benefits and risks.
Six days before the FDA cleared the Prolift, J&J agreed in a written response to say in the label that the safety and effectiveness of the device, compared to conventional surgical repair without mesh, “have not been demonstrated in randomized controlled clinical trials.”
Rather, J&J wrote, the substantial equivalence to earlier approved devices had been demonstrated through other tests.
The federal cases are In re Ethicon Inc., Pelvic Repair System Products Liability Litigation, 12-md-2327, U.S. District Court, Southern District of West Virginia (Charleston).
To contact the reporters on this story: David Voreacos in Newark, New Jersey at dvoreacos@bloomberg.net; Alex Nussbaum in New York at Anussbaum1@bloomberg.net
To contact the editors responsible for this story: Michael Hytha at mhytha@bloomberg.net; Reg Gale at rgale5@bloomberg.ne


Comment by retrievethis (FiDA blog/Joleen Chambers)
I am outraged that Congress will not remove the legislative loophole that allows untested medical devices to be implanted in the human body and has removed citizen rights to justice by providing "cover" for the industry.  Congress also has withheld adequate funding for the FDA so that it is weak and filled with industry insiders who have little compassion for the patient harm that is produced.  Consumer beware!

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