FDA still finds transvaginal mesh products too risky after final post-marketing study

After years of worrying about the risk of painful and debilitating pain complications of transvaginal mesh suffered by women who received products sold by a number of companies for use during pelvic repair surgery, federal regulators have concluded from a final post-marketing surveillance study conducted by Coloplat that the mesh is no better than native tissue repair, but carries much more risk.

Over the past decade, manufacturers have faced tens of thousands of transvaginal mesh pursuits worn by women, alleging the products are unreasonably unsafe and defective, and billions in mesh settlements have been paid by CR Bard, Boston Scientific, American Medical Systems (AMS), Coloplast and other manufacturers.

Post-marketing transvaginal mesh studies commissioned to assess risk

After years of aggressive marketing and promotion by manufacturers, transvaginal mesh has been widely used in the United States for the treatment of pelvic organ prolapse or female stress urinary incontinence, involving the use of synthetic mesh to strengthen a weakened vaginal wall or support the bladder.

Most of the products were introduced through the FDA’s controversial “fast track” approval process, which allowed manufacturers to introduce new products based on the design of earlier lattice products, without conducting extensive research to assess the safety or effectiveness of specific designs before they are widely used by the medical community.

In 2012, the FDA ordered 33 different manufacturers to perform long-term testing post-marketing studies on transvaginal meshafter the agency issued warnings about problems faced by women when the mesh eroded in the vagina, contracted or shrunk, caused infections, pelvic pain, urinary problems, vaginal scarring and other complications.

While a number of manufacturers voluntarily chose to stop selling the products, studies by Boston Scientific and Coloplast did not provide sufficient evidence to support the mesh’s continued use, leading the FDA to announce that he was remove transvaginal mesh from the US market in 2019.

In August 2021, the FDA announced the results of federally mandated studies involving Boston Scientific’s transvaginal meshconcluding that the products performed no better than native tissue repair, while adding health risks, such as mesh exposure and erosion.

The agency has now released similar results from the latest ongoing post-marketing studies involving Coloplast transvaginal mesh products, which appear to confirm that the FDA has no intention of changing its view of the risks and benefits to this stage.

Denise W. Whigham