Surgical Mesh - Complications Associated with Transvaginal Implantation of Surgical Mesh for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

Starting date:

February 4, 2010

Posting date:

February 5, 2010

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002369

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on Surgical Mesh for Stress Urinary Incontinence and Pelvic Organ Prolapse

February 4, 2010

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Emergency Medicine, Obstetrics and Gynecology, Intensive Care and other involved professional staff and post this Notice in your institution.

Subject: Complications Associated with Transvaginal Implantation of Surgical Mesh for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

Transvaginal placement of surgical mesh (also known as surgical tape or sling) is increasingly used in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Implantation of surgical mesh devices through incisions in the vaginal wall can offer a less invasive approach as compared to other conventional surgical treatment techniques. However, Health Canada is concerned about Canadian and international reports of various intraoperative and postoperative complications associated with the use of these medical devices.

Reported complications associated with the use of transvaginally-placed mesh for the treatment of SUI and POP include erosion (vaginal, urethral), pain including dyspareunia, infection as well as perforations and other injuries to adjacent organs including the bowel, bladder and blood vessels. Risk factors associated with these complications are not completely understood but may relate to both patient-specific factors such as age, overall health status, estrogen status and a history of previous surgery in the area as well as procedure-specific factors such as surgical technique and route of mesh placement. Required treatment for these adverse events varies depending on the complication but can involve surgical intervention including complete mesh removal.

In light of this and other available information, Health Canada recommends the following:

1. Review the labelling of relevant devices, especially sections concerning warnings, precautions and adverse reactions.
2. Inform patients during the presurgical consultation of adverse events that may occur. Though transvaginal implantation of surgical mesh is generally considered permanent, patients should be aware of the possible need for additional surgical procedures that may not always fully correct some potential complications.
3. Be observant both intraoperatively and postoperatively for signs of any complications associated with transvaginal mesh placement.
4. Be aware of and/or get training on proper case selection, initial implantation procedure and management of complications.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients implanted with transvaginally-placed surgical mesh should be reported to Health Canada at the following address:

Any suspected adverse incident can be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Telephone: The Inspectorate Hotline 1-800-267-9675

The Reporting Form and Guidelines can be obtained from the Health Canada Web site.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738