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

Starting date:
May 13, 2014
Posting date:
May 13, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-39475

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

May 13, 2014

To: Hospital Chief of Medical Staff

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

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

On February 4, 2010, Health Canada issued a Notice to Hospitals (NtH) informing healthcare professionals about complications associated with transvaginal implantation of surgical mesh for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).Footnote 1 This update is being issued to inform you that although many women treated with these devices have had good outcomes, Health Canada continues to receive reports of complications, including some serious and life-altering events, associated with the use of these surgical devices.

The use of mesh devices for the surgical management of POP and SUI may share some overlapping risks and complications however, their associated incidence, severity, and the management of complications are different.  It is important to recognize that some of these complications are not unique to mesh surgery and are known to occur with non-mesh procedures.

Recommendations for surgical mesh for POP procedures

  • Transvaginal mesh procedures for the treatment of POP are evolving procedures that may carry higher risk of complications than established traditional abdominally-placed mesh or native tissue repair procedures. In many cases, POP may be treated successfully without the use of mesh.
  • Be aware of the complications associated with transvaginal implantation of surgical mesh for the treatment of POP. Some of these complications may require additional surgery which may not fully correct them.
  • Surgeons performing transvaginal mesh procedures should have adequate training specific to the devices used at your institution, be familiar with the labelling of each device, in particular, sections concerning warnings and implantation technique.

Recommendations for surgical mesh for SUI procedures

The traditional mid-urethral sling procedures for the treatment of SUI have been extensively studied, and are commonly performed for SUI repair.

  • Single-incision mini sling procedures are novel techniques for the treatment of SUI and may carry higher risk of complications than the traditional mid-urethral sling procedures.
  • Be aware of the complications associated with transvaginal implantation of surgical mesh slings for the treatment of SUI. Some of these complications may require additional surgery which may not fully correct them.
  • Surgeons performing transvaginal mesh sling procedures should have adequate training specific to the devices used at your institution, be familiar with the labelling of each device, in particular, sections concerning warnings and implantation technique.

Reported complications

The use of transvaginal surgical mesh devices has been associated with reports of acute or chronic pain, mesh erosion (extrusion or exposure), infection, voiding dysfunction, dyspareunia (pain during sexual intercourse), organ or blood vessel perforation, neuromuscular damage, bleeding or hemorrhage, as well as recurrent POP or SUI.  Mesh contraction is an additional complication and its occurrence has been associated with reports of vaginal tightness and/or shortening.  The presence and severity of the complications may vary from patient to patient.  Revision surgery may be required and may not fully correct some complications.   

Additional recommendations for patient management

Health Canada recommends that healthcare professionals provide information to perspective mesh candidates regarding these procedures and devices:

  • Conduct preoperative counselling to inform patients about all treatment options.  These may include both non-surgical and surgical (with or without mesh).  Ensure patients are fully aware of the potential risks and benefits of each treatment option and provide patients with written documentation including device labelling when available.
  • If mesh procedure is considered, patients should be informed:
    • through what route the mesh will be placed (abdominal or transvaginal).
    • of the potential complications of mesh placement, especially perforation, acute or chronic pain, erosion, infection, dyspareunia, urinary problems and vaginal stricture.
    • that a mesh is considered a permanent implant; removal of mesh or correction of mesh-related complications may involve subsequent surgeries.
    • that complete removal of mesh may not be possible and additional surgeries may not fully correct some complications.  

The nature of risk factors associated with the complications continues to be clinically investigated. Healthcare professionals are encouraged to update their knowledge by reviewing relevant scientific literature and clinical guidelines,Footnote 2,Footnote 3,Footnote 4 and attending relevant training courses related to the use of these devices.

Health Canada continues to monitor the complications associated with the use of transvaginal surgical mesh devices and to work with manufacturers to evaluate device safety and effectiveness data as they become available. 

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 transvaginal surgical mesh devices for POP and SUI repair 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 Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

References:

Footnote 1

http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2010/14626a-eng.php

Return to footnote 1 referrer

Footnote 2

http://sogc.org/wp-content/uploads/2013/01/gui254TU1102E.pdf

Return to footnote 2 referrer

Footnote 3

http://sogc.org/wp-content/uploads/2013/01/gui213TU0808.pdf

Return to footnote 3 referrer

Footnote 4

http://www.cua.org/userfiles/files/Incontinence Guidelines 1-2012(1).pdf

Return to footnote 4 referrer

 


For more information

As an ongoing commitment to openness and transparency, Health Canada has begun to publish summaries of its drug safety reviews. Health Canada is looking at how summary safety reviews for medical devices could eventually be made available.