J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says (Bloomberg)

Discussion in 'The Lounge' started by Drew Wilson, Jan 5, 2012.

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  1. Drew Wilson

    Drew Wilson AKA IceCube Staff Member Moderator Contributor

    Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women.

    The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers, telling them to conduct three years of trials on safety and effectiveness, the agency’s William Maisel said yesterday in a telephone interview. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to 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 and heightened scrutiny of the FDA program that cleared the products for sale without human testing.

    “Now these companies are going to have to tell the truth,” said Lana Keeton, a mesh recipient and patient advocate from Austin, Texas. While companies say implants are safe, “up until now, there’s been no data,” she said. “It’s all been marketing.”

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