FDA orders new applications from pelvic mesh implant makers

Georgia residents expect government regulators to ensure that the medical devices sold in the United States are safe and fit for the purpose intended, but sometimes problems arise even with products that have withstood such scrutiny. One such situation developed with mesh implants that are designed to treat women who have suffered a pelvic collapse, and the makers of these devices were ordered by the FDA on Jan. 4 to submit new applications to demonstrate that their devices are effective and safe.

The regulatory agency took this step after hearing reports that pelvic mesh implants have been known to cause problems including infections and persistent bleeding that can sometimes require several surgical procedures to fully address. While some product safety advocates have applauded this decision, others have pointed out that it comes more than four years after the FDA noticed a higher complication rate among women with vaginal mesh implants compared than those who had received more traditional forms of treatment.

The makers of pelvic mesh implants introduced their products in the 1990s with claims that they would speed up healing times, but regulators say that the devices have so far failed to live up to these statements. Problems with the devices have led to a flood of product liability litigation, and one manufacturer paid $830 million to settle lawsuits in 2014 alone. The FDA has given the makers of pelvic mesh implants 30 months to submit the required paperwork.

Individuals who have suffered injury, loss or damage due to a defective or dangerous product may pursue remedies in civil court, and a personal injury attorney could file litigation on their behalf against the manufacturer involved. When the company that makes the product in question is based overseas, lawsuits could be filed against their American partners or distributors.

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