Information Update - Status of non-absorbable synthetic surgical mesh for the transvaginal repair of pelvic organ prolapse in Canada

OTTAWA, July 26, 2019 /CNW/ - Health Canada has completed a safety review of non-absorbable synthetic surgical mesh for the transvaginal (implanted through the vagina) repair of pelvic organ prolapse (POP) in Canada. The review found that non-absorbable synthetic transvaginal mesh should no longer be used for a certain type of POP repair, and that it should only be used in specific patient groups for other types of POP repair.

POP happens when weak or damaged muscles and tissues of the pelvic floor allow pelvic organs (e.g., bladder, uterus) to drop from their normal position and bulge into the wall of the vagina. Non-absorbable synthetic mesh is intended to be permanently implanted to reinforce the weakened vaginal wall for POP repair.

This transvaginal mesh has been associated with a number of complications following POP repair, including abdominal pain, pain during sexual intercourse, repeated infections, urinary problems, organ perforation, nerve damage, and mesh erosion (or exposure) through surrounding tissues. In some cases, additional surgery is needed to partially or completely remove the mesh. Even with multiple procedures, it may not be possible to correct some of these complications as the mesh is not designed to be removed.

In 2010 and 2014, Health Canada provided recommendations for health professionals to help reduce the risk of complications associated with the use of surgical mesh for the transvaginal repair of POP (see links below).

Health Canada undertook this latest safety review in light of ongoing safety concerns, newly published literature and clinical guidelines, as well as information from regulatory authorities in other countries.

The review concluded that non-absorbable synthetic transvaginal surgical mesh should no longer be used to treat a type of POP known as "posterior compartment" POP (a prolapse of the rectum), as recent evidence shows that this use is associated with an increased risk of complications compared to alternative treatment options. For other types of POP repair, the review concluded that non-absorbable synthetic transvaginal surgical mesh should be used only in specific patient groups: women at significant risk of or who have recurring POP, or women who are unable to undergo other surgical treatments.

The three companies that held active medical device licences in 2019 have indicated that they are no longer selling non-absorbable synthetic surgical mesh for the transvaginal repair of POP in Canada. The companies have cancelled their licences or have indicated they will do so shortly. Companies are removing unused stock from the market voluntarily except for one product (Restorelle DirectFix Anterior). In accordance with Health Canada's review, the manufacturer of Restorelle DirectFix Anterior has notified healthcare providers of the revised recommended patient population for the remaining supply of unused product. The table of affected products shows the status of each product.

The Department will continue to monitor the safety of these products, as it does for all health products on the market, and will take further action if new safety concerns are identified.

Affected products

Manufacturer	Medical Device Name	Licence Number	Status
Boston Scientific Corporation	Uphold LITE Vaginal Support System with Capio SLIM	98223	Company stopped sale and initiated a recall of unused product in May 2019. Company has indicated it will cancel its licence once the recall is complete.
Coloplast A/S	Exair Anterior and Posterior Compartment Prolapse Repair System	81556	Company cancelled its licence in May 2019. No product is available in Canada (company stopped sale in May 2016).
	Restorelle Polypropylene Mesh Sold under two trade names: Restorelle DirectFix Anterior Restorelle DirectFix Posterior	87285	Company cancelled its licence in June 2019 (affects both Restorelle DirectFix Anterior and DirectFix Posterior). Company stopped sale and is notifying physicians of the revised recommended patient population for any unused DirectFix Anterior. Company stopped sale and initiated a recall of unused DirectFix Posterior in July 2019.
Cousin Biotech	Implants pour le Traitement du Prolapsus Biomesh Soft Prolaps	77395	Company cancelled its licence in May 2019 No product is available in Canada (no sales in Canada since January 2014)

What you should do

Before considering surgery to repair POP:

• Ask your surgeon or physician about all treatment options and understand the risks and benefits of each treatment option. There are options that do not involve surgery, and surgical options that do not involve mesh. If you have posterior compartment POP, non-absorbable synthetic transvaginal surgical mesh should no longer be used.
• Talk to your healthcare provider if you have any questions or concerns.

If you have implanted non-absorbable synthetic transvaginal mesh to repair POP:

• Continue with routine follow-ups as recommended by your surgeon or physician. There is no need for additional action if you are satisfied with the surgery and you have no complications. These products are designed to be permanent and are not intended to be removed.
• Contact your healthcare provider if you develop complications, such as pelvic or groin pain, persistent vaginal discharge or bleeding, or pain during sexual intercourse.

Report health or safety concerns

• Report complaints involving medical devices to Health Canada.
• Stay connected with Health Canada and receive the latest advisories and product recalls.

Health Canada developed an Action Plan on Medical Devices, which lays out a three-part strategy to:

• improve how medical devices get on the Canadian market
• strengthen monitoring and follow-up for devices already in use, and
• provide Canadians with more information about the medical devices they rely on

In addition, to better support women's health, Health Canada has established a new Scientific Advisory Committee on Health Products for Women.

Related links:

• July 26, 2019, Summary Safety Review – Surgical mesh products – Assessing the potential risk of complications associated with transvaginal implantation of non-absorbable synthetic surgical mesh for the treatment of pelvic organ prolapse (POP) 
• May 13, 2014, Notice to Hospitals: Surgical Mesh - Complications associated with transvaginal implantation for the treatment of stress urinary incontinence and pelvic organ prolapse
• May 13, 2014, Public Communication: Information regarding the transvaginal implantation of surgical mesh devices for the treatment of pelvic organ prolapse and stress urinary incontinence
• February 4, 2010, Notice to Hospitals: Surgical Mesh - Complications associated with transvaginal implantation of surgical mesh for the treatment of stress urinary incontinence and pelvic organ prolapse

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SOURCE Health Canada

Media Inquiries: Health Canada, [phone], [email protected]; Public Inquiries: [phone], 1-866 225-0709