Transvaginal mesh pulled from Canadian market following safety review
Health Canada review concludes surgical mesh still safe to use in some cases, despite ban by U.S. FDA
Surgical mesh implants used to treat women's pelvic organ problems are being removed from the Canadian market following a safety review by Health Canada.
Transvaginal mesh is surgically implanted to repair pelvic organ prolapse (POP) — the dropping of the bladder, uterus, bowel or rectum from its normal position due to weakened or damaged tissue.
Health Canada acknowledged that some women who had the mesh implanted experienced debilitating side-effects, including abdominal pain, pain during sex, repeated infections, organ perforation, nerve damage and the mesh breaking apart.
The department announced it would review the safety of the mesh following an international investigation by media that included CBC News, Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists.
The Health Canada review concluded the mesh could continue to be used, but only in specific patient groups, such as women who have recurring POP or those unable to undergo other surgical treatments.
That decision falls short of the U.S. Food and Drug Administration's ban on the sale and distribution of the mesh, imposed in April after the agency concluding that the manufacturers did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications.
However, it's unclear if the mesh will continue to be implanted in those specific situations at all, as Health Canada announced the three manufacturers of transvaginal mesh sold in Canada have either stopped selling their products or will remove them from the market — possibly as a result of the FDA ban.
The companies include Boston Scientific, Cousin Biotech and Coloplast A/S.
The move by Health Canada follows a recommendation in 2017 by the Canadian Urological Association that "the currently available literature does not support the routine use of transvaginal mesh for prolapse repair."
The action taken by Health Canada and the FDA does not apply to other forms of the mesh, typically used to treat urinary incontinence in women or in hernia repair.
For women who have already had mesh implanted for organ prolapse, Health Canada recommends routine followup as recommended by their doctors, or that patients contact their doctors if they develop complications, such as groin pain.