Aug 08, 2019 in News --> Medical Devices

Health Canada Finds Transvaginal Mesh Unsafe

Last month, after a thorough review prompted by a CBC News and Toronto Star investigation, Health Canada announced that transvaginal mesh implants should no longer be used to treat women’s pelvic issues. The announcement is a relief to personal injury and medical malpractice lawyers who have met and read about numerous women affected by these devices.

What are Transvaginal Mesh Implants?

Transvaginal mesh is a variety of synthetic surgical implant used to treat pelvic organ prolapse (POP) in women. The mesh is implanted to support weak or damaged pelvic tissue, which prevents the bladder, uterus, rectum, or bowel from dropping from its normal position.

What are the Safety Risks?

Some women with transvaginal mesh implants experience life-changing complications, including chronic abdominal pain, chronic infection, organ perforation, nerve damage, and pain during sex, among others. These injuries may also result in serious mental trauma, which medical malpractice lawyers will consider in any potential lawsuit.

Health Canada Decision

A summary of the Health Canada safety review, released July 26, states the following:

“… compared to other treatment options, the transvaginal implantation of non-absorbable synthetic surgical mesh to treat posterior compartment prolapse (such as the rectum) poses a greater risk of complications including pain, repeated infections, and mesh erosion (or exposure) through surrounding tissues.”

The review also found that the use of transvaginal mesh for the repair of bladder or uterus prolapse “should only be used for patients who have significant risk factors for recurrence of POP or recurrent POP, or for whom alternative surgical treatments are not appropriate.”

As a result, Health Canada pledged to work with transvaginal mesh manufacturers to remove the product from the Canadian market and inform doctors that the mesh should only be used in specific patient groups. However, even those patients that qualify for transvaginal mesh use under Health Canada’s new guidelines are unlikely to receive the treatment. Perhaps due to the American Food and Drug Administration’s (FDA) nationwide ban on the sale and distribution of transvaginal mesh, imposed in April, the only three companies that manufacture the mesh for sale in Canada – Boston Scientific, Cousin Biotech, and Coloplast A/S – have already stopped selling or removed their products from the Canadian market.

If you or a member of your family has experienced complications related to a transvaginal mesh implant or any other kind of surgical mesh, contact Neinstein Personal Injury Lawyers to arrange a free, no-obligation consultation today. Our team of experienced medical malpractice lawyers will explain your legal options and provide guidance and advice based on the specifics of your case.

Image credit: Anpol42/Wikimedia Commons