FDA Reclassifies Transvaginal Mesh Devices Amid Thousands of Injuries

Thousands of individuals have suffered injury from transvaginal mesh implants since they were first approved for use roughly 15 years ago. Now, the FDA is taking action and helping to prevent injuries to future recipients of the product.

Thousands of individuals have suffered injury from transvaginal mesh implants since they were first approved for use roughly 15 years ago. In 2010 alone, 70,000 women underwent mesh surgical procedures in order to treat Pelvic Organ Prolapse and Stress Urinary Incontinence. Many of these individuals have suffered various injuries ranging from perforation of the bladder to erosion of the vaginal epithelium due to the defective synthetic mesh devices.

Media outlets everywhere have profiled the dangers of the product. Finally, the Food and Drug Administration-the federal agency that regulates prescriptions drugs and medical devices and referred to as the FDA, is stepping in to help prevent injury to future recipients of the implant.

According to Dr. William Maisel, deputy director of science at the FDA’s Center for Devices and Radiological Health, the “FDA has identified clear risks associated with surgical mesh for the transvaginal repair of Pelvic Organ Prolapse and is now proposing to address those risks for more safe and effective products.”

Specifically, the FDA plans to reclassify the product.

Stricter oversight over transvaginal mesh implants

Essentially, medical devices or products are categorized under three different classifications: Class I, Class II, and Class III. Devices labeled Class I are considered “high risk.” Manufacturers of Class I devices must go through a more rigorous application procedure and show “safety and effectiveness” before the FDA will allow the product to be placed on the market. Presently transvaginal mesh devices are categorized as Class II products, posing a moderate risk.

The new rule will take effect after the mandatory 90 public comment period. The reclassification, however, will only apply to transvaginal mesh products. Other, similar products will stay at their current classification status.

Transvaginal mesh litigation

Along with regulatory action by the federal government, the civil court system is seemingly providing recourse for those injured and affected by the product.

Lawsuits all over the country have been filed against various makers of the transvaginal mesh device including Johnson & Johnson, C.R. Bard Inc., Endo International Plc, and others.

Some plaintiffs have received successful judgments at trial. Others have received settlement awards. In fact, earlier this month, media outlets reported that Endo has agreed to pay $830 million to settle approximately 20,000 lawsuits.

Fortunately, the new rule gives weight to the thousands of transvaginal mesh lawsuits still pending in the court system. More manufacturers of the product may agree to settle more cases.

To date, approximately 275,000 people worldwide have received transvaginal mesh implants.

Keywords: transvaginal mesh, product liability, product defects

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