Transvaginal mesh called off from Canadian market following FDA’s ban

Following a safety review by Health Canada, surgical mesh implants used for the treatment of women’s pelvic organ problems are now being removed from the Canadian market.

Transvaginal mesh is surgically implanted for the repairmen of pelvic organ prolapse the dropping of the uterus, bladder, rectum or bowel from its normal position due to damaged or weakened tissue.

It was acknowledged by Health Canada that debilitating side-effects were experienced by some women who had the mesh implanted experienced, including repeated infections, abdominal pain, pain during sex, organ perforation, nerve damage & the mesh breaking apart.

It was announced by the department that it would be reviewing the safety of the mesh following an international investigation by media would be inclusive of the Toronto Star, Radio-Canada, CBC News & the Washington-based International Consortium of Investigative Journalists.

Review by the Health Canada concluded that the mesh could continue to be used, but only in certain patient groups, like women who have recurring Pelvic Organ Prolapse or those who are unable to undergo other surgical treatments.

That decision falls short of the United States Food & Drug Administration’s ban imposed in April on the sale & distribution of the mesh after the agency concluded that the manufacturers didn’t demonstrate a reasonable assurance of safety & effectiveness of these devices in their premarket applications.

However, it is uncertain whether the mesh will be continuing to be implanted in those specific situations at all, as according to the announcement of Health Canada that the three manufacturers of transvaginal mesh sold in Canada have either put a stop at selling their products or will remove them from the market, possibly as a result of the Food & Drug Administration’s ban.

The firms are inclusive of Cousin Biotech, Boston Scientific, & Coloplast A/S.