Vaginal surgical mesh: Risks
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Vaginal surgical mesh in Canada
Like all medical devices, vaginal surgical mesh have benefits and risks. Licensing of a medical device means:
- the benefits outweigh the risks associated with the use of the device
- the risks have been reduced as much as possible by the manufacturer
There can be important new information about a device's safety, effectiveness or quality after licensing. For this reason, we continue to monitor the benefits and risks of products while they are marketed in Canada.
If you are considering vaginal surgical mesh, discuss the risks and benefits with your health care provider. Carefully review any information provided to you by your health care provider.
You are also encouraged to review information about the risks of specific types of vaginal surgical mesh or risks specific to the type of surgical approach. For example, you can:
- visit our website for safety information
- search for Canadian recalls and safety alerts associated with vaginal surgical mesh
- ask your doctor for the patient brochure, patient labelling and instructions for use
You can also find more information about each manufacturer's vaginal surgical mesh in the manufacturer’s product label.
Common risks and adverse events with vaginal surgical mesh
There are many complications and risks associated with vaginal surgical mesh. These risks are explained in the product labelling, which can be obtained from your surgeon.
The use of vaginal surgical mesh for treating POP and SUI share similar risks and complications, but there is a difference in their associated severity, incidence and management. Such risks and complications have been reported to include:
- acute or chronic lower abdominal/pelvic pain, including painful intercourse
- bleeding
- infection
- urinary problems
- nerve/muscle damage
- damage to pelvic structures and surrounding tissues, including fecal incontinence and/or difficulty to defecate
- recurrent POP and/or SUI
- sexual dysfunction
- organ or blood vessel perforation
- vaginal scarring, tightness and/or shortening
- a need for surgical intervention, including potential for removal
- mesh erosion (also called exposure, extrusion or perforation)
With the exception of mesh erosion, such complications can also occur after a non-mesh surgical procedure.
Current evidence is unable to confirm the use of vaginal surgical mesh as a factor in the development of cancers, autoimmune or systemic issues (such as chronic fatigue, headaches and weakness). However, some patients have reported such concerns after implantation of vaginal surgical mesh.
Vaginal surgical mesh removal
Vaginal surgical mesh is intended to be permanent. There are some situations where partial or full removal of the implanted mesh may be warranted to treat specific mesh-related complications. In some cases, complete removal may not be possible or may require multiple surgeries. However, additional surgery may not correct some complications. This is because tissues can grow around and through the mesh by the time the complications appear, making it difficult or impossible to remove the mesh completely.
When considering a vaginal surgical mesh procedure, ensure that you are aware of the benefits and the risks of this procedure. You should also have discussed this option with your doctor and confirmed that this procedure is the best option for you. Refer to the list of questions to consider asking your doctor and/or surgeon.
You are encouraged to:
- review the information provided by your health care provider to understand these and other potential adverse events
- report a medical device problem related to the use of vaginal surgical mesh
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