FDA: Vaginal Mesh is Class III “High Risk” Device

Texas Vaginal Mesh LawyerJanuary 4, 2016 — The FDA has strengthened approval requirements for vaginal mesh and reclassified them as Class III (“high risk”) medical devices.

The announcement comes after a “significant increase” in the number of adverse event reports associated with vaginal mesh.

Manufacturers of vaginal mesh products on the market have 30 months to file Pre-Market Approval (PMA) applications with the FDA. It is the most stringent type of device approval and must contain evidence to assure the device is safe and effective.

According to Dr. William Maisel, deputy director of science and chief scientist for the agency’s Center for Devices & Radiological Health:

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse.”

The new requirements only affect vaginal mesh for transvaginal pelvic organ prolapse (POP) repair — not stress urinary incontinence or abdominal POP repair, according to the FDA.

Most vaginal mesh products currently on the market were approved with 510(k) applications, which allows new devices on the market without requiring new safety studies so long as the device is “equivalent” to another device on the market.

The problem is that many products were approved based on their “equivalency” to the ProteGen, a pelvic sling made by Boston Scientific that was recalled in the 1990s for safety reasons. Not surprisingly, women who were implanted with similar devices experienced similar problems — including devastating erosion, chronic pain, infections, and more.

Approximately 100,000 lawsuits have been filed against vaginal mesh manufacturers by women who were injured. Just weeks ago, a jury in Philadelphia ordered Johnson & Johnson to pay $12.5 million to a woman who was left in chronic pain after her Prolift implant eroded into her bladder.

Need a Vaginal Mesh Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas vaginal mesh lawyers for a free lawsuit review.

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