Vaginal surgical mesh: Evidence and safety reviews

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Pre-market review

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:

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

Since 2010, Health Canada has completed several safety reviews to assess surgical mesh used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The results of these safety reviews can be found in the Links to Notices and Safety Reviews section.

Links to notices and safety reviews

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