Product Wiki · Recalls · Government of Canada recall portal

Status of non-absorbable synthetic surgical mesh for the transvaginal… — recall 59983

Government of Canada recall portal · Canada · 2019-07-26

As described by Government of Canada recall portal: Status of non-absorbable synthetic surgical mesh for the transvaginal repair of pelvic organ prolapse in Canada

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Agency
Government of Canada recall portal
Recall identifier
59983
Date of alert
2019-07-26
Country / jurisdiction
Canada
Risk type
recall
Product category
Medical devices
Product type
Communications and Public Affairs Branch
Reported risk: July 26, 2019 For immediate release POP happens when weak or damaged muscles and tissues of the pelvic floor allow pelvic organs (e.g., bladder, uterus) to drop from their normal position and bulge into the wall of the vagina. Non-absorbable synthetic mesh is intended to be permanently implanted to reinforce the weakened vaginal wall for POP repair. This transvaginal mesh has been associated with a number of complications following POP repair, including abdominal pain, pain during sexual intercourse, repeated infections, urinary problems, organ perforation, nerve damage, and mesh erosion (or exposure) through surrounding tissues. In some cases, additional surgery is needed to partially or completely remove the mesh. Even with multiple procedures, it may not be possible to correct some of these complications as the mesh is not designed to be removed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/status-non-absorbable-syntheti

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