Pelvic mesh and bladder sling problems have been detailed by major medical clinics for decades, yet the mesh and slings still remain on the market and are still being implanted in women. Major medical clinics and university affiliated medical institutions, such as the Cleveland Clinic, have published articles and treatise on the mesh complications.

Pelvic Mesh Claims

From 2011 to the present, over 100,000 pelvic mesh claims of defective products causing injuries have been resolved. Settlements and verdicts involving multimillions have been made with many pelvic mesh products taken off the market. We are accepting cases of certain defective pelvic mesh products that have been surgically removed or revised.

FDA Warnings You May Not Know About

In February 2019, the FDA convened an advisory panel of experts that recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months. The FDA agreed with these recommendations, and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve Pelvic Organ Prolapse devices. Even though these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required to continue follow up of the subjects already enrolled in their 522 studies.

July 2011: An FDA Safety Communication identified concerns and issued new recommendations about the use of surgical mesh for transvaginal repair of Pelvic Organ Prolapse (POP).

September 2011: FDA convened a public meeting of the Obstetrics and Gynecology Devices Panel to discuss the benefits and risks of this use. Subsequently, the FDA issued 131 orders to conduct post market surveillance studies (“522 orders”) to 34 manufacturers of surgical mesh for transvaginal repair of POP. Most manufacturers elected to stop marketing surgical meshfor transvaginal repair of POP after receiving their 522 orders.

January 2016: The FDA completed its reclassification of surgical mesh for transvaginal repair of POP into the highest risk class of devices (class III), which requires premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to stay on the market.

July 5, 2018: This was the deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal POP repair. Manufacturers that did not file PMAs by this deadline were required to withdraw their products from the market. Those that did file PMAs were allowed to keep their mesh products on the market while the FDA reviewed their PMAs.

February 12, 2019: The FDA convened an advisory committee meeting to share the available evidence and seek expert opinions on how to evaluate the risks and benefits of these devices. The committee evaluated mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices. Boston Scientific filed two PMAs for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior.

In February 2019, the FDA convened an advisory panel of experts that recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months. The FDA agreed with these recommendations, and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve Pelvic Organ Prolapse devices. Even though these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required to continue follow up of the subjects already enrolled in their 522 studies.