J&J Sold Vaginal Mesh Implant After Sales Halt
Ordered
By David Voreacos and Alex
Nussbaum on June 26, 2012
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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