FDA Orders Safety Studies for J&J and C.R. Bard Vaginal Mesh
Jan. 4 (Bloomberg Businessweek) — The Food and Drug Administration ordered Johnson & Johnson and C.R. Bard Inc. to study rates of organ damage, infection and painful sex linked to vaginal implants, reacting to doctors and patients who say the devices have harmed women.
The regulator wrote to 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 FDA’s William Maisel said in a telephone interview. That followed an agency report in July that found a fivefold jump in deaths, injuries or malfunctions.
Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or weakened 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 less than 1 percent to $65.33 at 3:19 p.m. New York time. C.R. Bard declined less than 1 percent to $86.10. J&J is based in New Brunswick, New Jersey, and Bard in Murray Hill, New Jersey.
The letters ask each manufacturer to collect data on the transvaginal procedures, in which the 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 Endo Pharmaceuticals Holding Inc. of Chadds Ford, Pennsylvania; and Boston Scientific Corp., based in Natick, Massachusetts. The companies have 30 days to respond.
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 Matthew Johnson, a spokesman for J&J’s Ethicon unit, which makes the devices.
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 before they can reach the market. The FDA hasn’t made a decision on that 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.
–With assistance by Michelle Fay Cortez in Minneapolis. Editors: Bruce Rule, Reg Gale
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