FDA May Tighten Scrutiny of Transvaginal Mesh Surgical Products – But Is That Too Little, Too Late?

We are happy to hear that the FDA is taking a serious look at transvaginal mesh devices. But that action may be too little and too late for thousands of women who have been harmed by these medical products.

Our product injury lawyers at Grimes Teich Anderson may be able to help you if you or someone you love has been injured by transvaginal mesh.

Transvaginal mesh surgical products have come under fire in recent years for causing severe injuries and complications as a result of erosion and disintegration of the mesh support, which can cut through the vaginal lining and perforate the bladder, bowels, and other organs.

Makers of transvaginal mesh (TVM) medical devices would have to seek federal approval before being allowed to sell and distribute certain products if a regulatory proposal under review is finalized.

The Food and Drug Administration proposal would re-classify certain TVM devices from the current “moderate-risk” category to “high-risk.” If the FDA authorizes this change in category, TVM manufacturers would for the first time have to submit a pre-market application for a product safety evaluation and approval. The current rule allows distribution and sales without federal pre-approval.

Uses of TVM Products

A hysterectomy, menopause or child birth can cause a woman’s uterus, bladder or rectum to drop out of place due to weakened muscles or ligaments. This increased stress on the woman’s vagina can cause pain and discomfort, as well as urinary incontinence in some cases.

One treatment for pelvic organ prolapse (POP) or incontinence involves implanting a surgical mesh device in the pelvis. The sling-like device supports weak or damaged muscle and organs. The mesh is made of synthetic or biological material.

Thousands of personal injury lawsuits involving TVM devices are pending in state courts around the country, and the approximately 50,000 pending federal cases have been consolidated in federal court in West Virginia.

FDA: Current Regulations Not Enough

The FDA proposal would require TVM manufacturers to provide clinical data to demonstrate the safety and effectiveness of the surgical mesh used to treat transvaginal POP. In making the proposal, the FDA said current regulations do not provide sufficient safety assurances for these devices.

The FDA based its proposal on safety concerns raised by clinicians and individuals, as well as published information about the medical problems TVM surgical products have caused. The FDA is particularly concerned about multiple surgeries some women have had to undergo to remove mesh that has eroded or has perforated tissue and organs.

In its summary of the proposal, the FDA indicates that while transvaginal mesh repair can successfully restore anatomy, the procedure does not appear to provide superior clinical benefit to traditional non-mesh treatments, and its risks are greater than traditional treatments.

Defective TVM devices can lead to irreversible complications, and may worsen the treated medical conditions.

The FDA is accepting public comments up to July 30, after which it will determine whether to make the regulatory proposal final.

Transvaginal Mesh Complications

In addition to organ or tissue perforation, complications from defective TVM devices include:

• Pelvic bleeding • Chronic pain • Recurring prolapse • Infections • Vaginal scarring and shrinkage • Vaginal discharge • Abdominal pressure • Pain during sexual intercourse
Questions About Transvaginal Mesh Injuries?

If you have been harmed by a TVM product, remember that you are not alone. In one recent year, nearly 300,000 women suffered from POP, and 70,000 women underwent TVM surgery. Grimes Teich Anderson LLP handles product liability cases. We represent people in Western North Carolina and Upstate South Carolina and can answer any questions you have about your legal options. Call us today for a free case evaluation. 1-800-533-6845

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