FDA Orders Safety Studies for Vaginal Implants Made
By J&J and C.R. Bard
By Alex Nussbaum and David Voreacos - Jan 4, 2012 4:31 PM CT
U.S. regulators ordered Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) to study rates
of organ damage, infection and painful sex linked to vaginal mesh implants, reacting to
doctors and patients who say the devices have harmed women.The Food and Drug
Administration wrote J&J, C.R. Bard and 31 other manufacturers yesterday, asking them
to collect as much as three years of data on the safety and effectiveness of the implants,
the agency’s William Maisel said today in a telephone interview. That followed an FDA
report in July that found a fivefold jump in deaths, injuries or malfunctions linked to
some of the products.
Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices’ alleged failures have spurred more than 650 lawsuits against manufacturers, as well as heightened scrutiny of the FDA program that cleared meshes for sale without human testing.
“We believe there are certain uses of mesh where we need additional data to help guide the clinical community,” said Maisel, deputy director of science for the FDA’s device-approval center. “Our goal is to make sure the right women use it at the right time.”
J&J, the biggest maker of vaginal mesh, fell (JNJ) less than 1 percent to $65.48 at the close in New York. C.R. Bard also declined (BCR) less than 1 percent to $86.08. J&J is based in New Brunswick, New Jersey, and Bard in Murray Hill, New Jersey.
Threaded in Place
The letters ask each manufacturer to collect data on the results of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina. The FDA said in July that it wasn’t clear from available studies whether the devices provided any benefit over older methods in many cases.
The requests also went to companies including Endo Pharmaceuticals Holding Inc. (ENDP) of Chadds Ford, Pennsylvania, and Boston Scientific Corp. (BSX), based in Natick, Massachusetts. The companies have 30 days to respond.
The meshes were approved through the FDA’s 510(k) system, which allows products to reach the market without human testing if the agency decides they’re similar to devices already for sale. In October, Bloomberg News reported many implants can trace their approvals back to a Boston Scientific mesh recalled for safety problems in 1999.
“Now these companies are going to have to tell the truth,” said Lana Keeton, the Austin, Texas, founder of Truth In Medicine, an advocacy group for mesh patients. Keeton sued J&J over injuries she blamed on a 2001 implant. The case was dismissed by a federal judge in 2007.
While companies say the devices are safe, “up until now, there’s been no data, there’s no denominator to glean that from,” said Keeton, who has also worked as a paid consultant for attorneys suing mesh makers. “It’s just been marketing.”
Matthew Johnson, a spokesman for J&J’s Ethicon unit that makes the devices, said the company was reviewing the correspondence from the FDA.
“Ethicon’s transvaginal mesh devices are already among the most studied devices on the market, and we will continue to support their use in surgical repair with clinical evidence, through investigator-initiated and company-sponsored trials,” he said in an e-mail.
Kevin Wiggins from Endo Pharmaceuticals and Eric Olson from Boston Scientific didn’t immediately return phone calls seeking comment. Messages also weren’t immediately returned by Scott Lowry, a Bard spokesman.
The edges of mesh fibers can constrict or cut into internal organs after they’ve been implanted, studies have found. The procedure is also prone to infection because the vagina through which the devices are inserted isn’t a sterile environment, said Clifford Wheeless, an emeritus associate gynecology professor at Johns Hopkins University School of Medicine, in a telephone interview last year.
In September, an advisory panel recommended the FDA reclassify mesh used for pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs, as “high-risk” devices that require human testing. The FDA hasn’t made a decision yet, Maisel said today. He said the agency also isn’t likely to heed the call of some patient advocates for a complete recall.
“There’s strong support in the clinical community that mesh serves a role for certain patients,” he said. “Our goal is not to completely remove these products from the market.”
Manufacturers sell about $175 million worth of prolapse mesh worldwide, Bard estimated on a conference call in 2010.
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