OTTAWA – Health Canada is informing patients about the potential risk of complications associated with transvaginal implantation of surgical mesh devices for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Although many women treated with these devices have had good outcomes, Health Canada continues to receive reports of complications. The use of transvaginal mesh devices for POP and SUI repair has been associated with reports of acute or chronic pain, pain during sexual intercourse, mesh erosion and shrinkage, infection, urinary problems, organ or blood vessel perforation, nerve damage, bleeding, vaginal tightness and/or shortening, and recurrent POP and SUI. Additional surgery may be required and may not fully correct some complications. Health Canada is reviewing labelling related to these products to determine if it provides appropriate safety information. Additional safety information in the labelling will be requested, as needed. It is important to recognize that there is a risk of complications with any surgical procedure. Some of these complications can also occur with non-mesh surgery. There may be some similar risks when using transvaginal mesh devices to treat POP and SUI, but the complications differ in their severity, how frequently they occur, and how they are managed. POP occurs when the tissues holding the pelvic organs weaken and the pelvic organs fall into the wall of the vagina. The organs involved in POP may include the bladder, the uterus, the vagina, the small bowel, and/or the rectum. The mesh products reinforce the weakened vaginal wall in order to treat POP. SUI is an involuntary leakage of urine during an activity such as sneezing, coughing, laughing or physical movements. The mesh products support the urethra in order to treat SUI. In Canada, medical devices such as surgical mesh are subject to a rigorous review process regarding their safety and effectiveness prior to being approved for use. The Department continues to monitor the safety of surgical mesh devices for the treatment of SUI and POP and will inform Canadians, as appropriate, if new safety information is identified.
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