Summary Safety Review - Surgical mesh products - Assessing the potential risk of complications associated with transvaginal implantation of non-absorbable synthetic surgical mesh for the trea™ent of pelvic organ prolapse (POP)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2019-07-26

Product

Surgical mesh products made from non-absorbable synthetic (polypropylene) material that are used for the transvaginal repair of pelvic organ prolapse (POP)

Potential Safety Issue

Complications associated with non-absorbable synthetic surgical mesh products used for the transvaginal repair of pelvic organ prolapse.

Key Messages

  • Pelvic organ prolapse (POP) is a drop or bulge (prolapse) of pelvic organs because weakened tissue and muscle can no longer support them. Pelvic organ prolapse can involve the bladder (anterior compartment), the uterus (apical compartment), and/or the rectum (posterior compartment).
  • Synthetic, non-absorbable surgical mesh products indicated for the treatment of POP are classified as medical devices in Canada. Implantation of the mesh by surgeons takes place either through the vagina (transvaginally) or through an incision in the abdomen (transabdominally).
  • Health Canada has updated its previous safety reviews on complications of transvaginally implanted synthetic surgical mesh used for the repair of POP. The update was triggered by ongoing safety concerns, newly published literature and clinical guidelines, and information issued by international regulatory agencies.
  • Health Canada's safety review found that 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.
  • Health Canada's review also found that the use of non-absorbable synthetic mesh for the transvaginal surgical repair of anterior (bladder) and/or apical (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 of the safety review, Health Canada will:
    • work with the manufacturer to remove synthetic surgical mesh devices indicated for the transvaginal repair of posterior compartment POP from the Canadian market;
    • work with the manufacturer to inform health care professionals that synthetic surgical mesh implanted transvaginally for the repair of anterior and/or apical compartment POP should only be performed in specific patient groups;
    • issue an Information Update to inform Canadians about this new safety information, including what patients with surgical mesh implanted transvaginally for the treatment of POP should do; and
    • continue to actively monitor transvaginal synthetic mesh products.

Overview

Pelvic organ prolapse (POP) is a drop or bulge (prolapse) of pelvic organs because weakened tissue and muscle can no longer support them.

Pelvic organ prolapse usually involves one or more pelvic organs, such as the bladder, the tube that empties the bladder (urethra), the womb (uterus), or the rectum. When pelvic floor muscles and tissues are weak or damaged, these organs can drop from their normal position and bulge into the wall of the vagina. There are different degrees of prolapse depending on how far the organ(s) have bulged. Symptoms of POP depend on the type and severity of the prolapse, and can include incontinence, difficulty urinating or painful intercourse. While POP is not a life-threatening condition, it can have a significant negative impact on quality of life.

Surgery may be an option for women when other therapies fail. Surgical procedures may involve entering through the vagina or the abdomen, and may include using surgical mesh. Over the past decade, there have been reports of complications related to the use of synthetic surgical mesh for the transvaginal repair of POP.

These reports have triggered many regulatory actions internationally, including several safety reviews and communications by Health Canada1-3. In 2014, Health Canada completed a safety review and recommended that healthcare professionals:

  • conduct preoperative counselling to inform patients about all treatment options, including both non-surgical and surgical (with or without meshes);
  • ensure that patients are fully aware of the potential risks and benefits of each treatment option; and
  • provide patients with written documentation, if available, including device safety information (Instructions for Use).

Despite the issuance of communications about this safety issue, as well as newly published literature, clinical guidelines, and information issued by international regulatory agencies, there remain ongoing concerns about surgical mesh products used transvaginally. As a result, Health Canada updated the 2014 safety review. This new review includes updated Canadian-specific reports of incidents and device usage data, clinical literature and guidelines, ongoing international regulatory activities, and input from Canadian medical associations on the use of these devices.

Use in Canada

  • In Canada, surgical mesh made of non-absorbable synthetic (polypropylene) material indicated for the transvaginal repair of POP is categorized as a Class III medical device, the second highest risk class of medical devices.
  • Once implanted, non-absorbable, synthetic surgical mesh is considered a permanent implant in the body.
  • When this safety review began, there were three manufacturers with licences in Canada for non-absorbable synthetic surgical mesh indicated for the transvaginal repair of POP: Coloplast A/S, Boston Scientific Corp., and Cousin Biotech.

Safety Review Findings

  • Since the 2014 safety review, Health Canada received three additional reportsa of incidents in Canada with the use of these mesh products. The incident reports describe urinary problems (retention/voiding dysfunction), ongoing pain in the thigh, and injury to muscles or nerves.
  • This 2019 safety review found that the use of transvaginal mesh for the repair of POP in Canada significantly decreased from 2008 to 2018. In addition, available data showed that bladder prolapse repair was the most frequently reported reason for use.
  • The non-absorbable synthetic (polypropylene) mesh products have risks related to the material, such as mesh eroding through the surrounding soft tissues (erosions/exposure), repeated infection, pain that may be related to mesh shortening (contracture), and/or the resulting need for additional surgery to remove the mesh (whole or part). Even with multiple procedures, it may not always be possible to correct some of these complications.
  • Both the clinical literature and input received from Canadian medical specialty organizations indicated that certain groups of patients can benefit from the use of surgical mesh implanted transvaginally for the repair of bladder or uterus prolapse. They include patients with a significant risk for recurrence of POP, with recurrent prolapse, or for whom the implantation of mesh through an abdominal procedure is not advised due to health conditions.
  • Compared to alternative treatment options (e.g., using the patient's own tissue to repair the prolapse), the risks of transvaginal implantation of non-absorbable, synthetic surgical mesh for the repair of rectum prolapse outweighed the benefits.
  • The experience of surgeons, as well as selecting appropriate patients and providing patient counselling, were found to play important roles in the success of procedures that use transvaginal mesh for the repair of POP. Canadian medical specialty organizations recommended that surgeons performing transvaginal surgery for POP repair should be specifically trained and have experience in transvaginal mesh surgical procedures.

Conclusions and actions

  • Health Canada's 2019 safety review found that the use of non-absorbable, synthetic surgical mesh implanted transvaginally to repair rectum prolapse is associated with an increased risk of complications compared to alternative treatment options.
  • Health Canada's review also found that the use of synthetic mesh for the treatment of POP transvaginally, when used for bladder and uterus prolapses, should be only be 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 of the safety review, Health Canada will:
    • work with the manaufacturer to remove synthetic surgical mesh devices indicated for the transvaginal repair of posterior compartment POP from the Canadian market;
    • work with the manufacturer to inform healthcare professionals that synthetic surgical mesh implanted transvaginally for the repair of anterior and/or apical compartment POP should only be performed in specific patient groups;
    • issue a safety communication to inform Canadians and healthcare professionals about this new information and what patients should do; and
    • continue to actively monitor transvaginal synthetic mesh products.

Additional information

Since the completion of this safety review4, all manufacturers have notified Health Canada that licences for non-absorbable, synthetic surgical mesh products indicated for the transvaginal repair of POP are to be cancelled. All unused products indicated for the transvaginal repair of posterior compartment POP are being actively removed from the market. Healthcare providers have been notified of the revised recommended patient population for the use of non-absorbable, synthetic mesh for transvaginal repair of bladder and uterus prolapse.

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports, and what is known about the use of these medical devices both in Canada and internationally.

For additional information about Health Canada's assessment, contact the Marketed Health Products Directorate.

If manufacturers or industry associations require more information at this time, they are encouraged to contact the Therapeutic Products Directorate (hc.tpdgeneral-generaldpt.sc@canada.ca).

References

  1. Surgical Mesh - Complications associated with transvaginal implantation for the treatment of stress urinary incontinence and pelvic organ prolapse - Notice to Hospitals.
  2. Information regarding the transvaginal implantation of surgical mesh devices for the treatment of pelvic organ prolapse and stress urinary incontinence.
  3. Surgical Mesh - Complications associated with transvaginal implantation of surgical mesh for the treatment of stress urinary incontinence and pelvic organ prolapse.
  4. Status of non-absorbable synthetic surgical mesh for the transvaginal repair of pelvic organ prolapse in Canada

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