Canadian health authorities are halting the use of transvaginal mesh in most pelvic surgeries but stopped short of joining the United States in instituting an outright ban on the surgical product.
Health Canada, the country’s medical safety watchdog, announced the move following a safety review, as CBC/Radio-Canada reported. The analysis revealed a rash of debilitating side-effects among women implanted with transvaginal mesh. Patients reported experiencing punctured organs, nerve damage, recurrent infections, abdominal pain, pain during sex and instances where the mesh broke apart inside them.
Transvaginal mesh is a type of medical netting. The mesh, usually made from synthetic polypropylene or polyester, is often used to treat pelvic organ prolapse (POP), a medical condition where the uterus, bladder, or other pelvic organs drop into the vaginal canal due to weakened support tissues. About one in eight women will need surgery to repair POP, and a portion of these surgeries use surgical mesh.
Canadian authorities were mixed on whether mesh could be used at all going forward. Health Canada initially said mesh could be used, but only among female patients with recurring POP or those for whom other surgical treatments weren’t an option, per CBC/Radio-Canada. But it also announced the three manufacturers of the product were stopping sales in the country.
The FDA first approved mesh for POP repair in 2002 as a moderate-risk medical device, according to Merck Manuals. Then in April, the FDA pulled transvaginal mesh from the market, warning that the safety risks outweighed the product’s benefits. The FDA determined that mesh-manufacturers Boston Scientific and Coloplast failed to provide “reasonable assurance of safety and effectiveness” of the product.
The most common side effect of surgical treatment with the products is mesh erosion, where the netting migrates from where it was placed surgically. According to data from 110 studies of 11,785 women whose POP repair used mesh, about one in 10 women experienced mesh erosion within one year, MedTruth reported.
The states of California, Washington, Kentucky and Mississippi have sued over the safety of the mesh products, saying the mesh manufacturer Johnson & Johnson failed to fully disclose the safety risks of its product.