Vaginal surgical mesh: Evidence and safety reviews
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Before any medical device such as surgical mesh can be licensed for sale in Canada it must be assessed for safety, effectiveness and quality.
The pre-market review of medical devices like surgical mesh includes an assessment of the regulatory and scientific evidence supporting the safety and effectiveness of the medical device.
The manufacturer is required to file a medical device licence application to Health Canada containing the applicable supporting evidence for the medical device. The scope of evidence required for the pre-market review of surgical mesh is published in our Health Canada guidelines.
After Health Canada reviews the evidence, a recommendation for licence approval may be granted if:
- the medical device meets all requirements of the Medical Devices Regulations
- the benefits are deemed to outweigh the risks when the medical device is used as intended
A medical device licence (MDL) is granted based on an approval recommendation.
The Medical Devices Active Licence Listing (MDALL) contains the list of currently and previously licensed surgical mesh.
Safety reviews and decisions
The results of these safety reviews can be found in the Links to Notices and Safety Reviews section.
Links to notices and safety reviews
- Single incision mini-sling (SIMS) made from non-absorbable synthetic material (polypropylene) - Summary Safety Review
- Status of non-absorbable synthetic surgical mesh for the transvaginal repair of pelvic organ prolapse in Canada
- Surgical Mesh - Complications associated with transvaginal implantation for the treatment of stress urinary incontinence and pelvic organ prolapse - Notice to Hospitals.
- Information regarding the transvaginal implantation of surgical mesh devices for the treatment of pelvic organ prolapse and stress urinary incontinence.
- Surgical Mesh - Complications associated with transvaginal implantation of surgical mesh for the treatment of stress urinary incontinence and pelvic organ prolapse.
- Summary Safety reviews - Surgical mesh products made from non-absorbable synthetic (polypropylene) material that are used for the transvaginal repair of pelvic organ prolapse (POP)
- Information Regarding the Transvaginal Implantation of Surgical Mesh Devices for the Treatment of Pelvic Organ Prolapse and Stress Urinary Incontinence.
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