If you have had surgery for Pelvic Organ Prolapse, (also known as POP) and you received a transvaginal mesh implant, you could be at risk! For women who have Pelvic Organ Prolapse, there is a mesh that can be placed through the vagina to repair the POP. In July of 2011 the FDA released a warning stating patients who have the surgical mesh placement through the vagina to repair POP mat have been exposed to a greater risk.
What you need to know:
- FDA says there is no evidence of clinical benefit such as improved quality of life with the surgical placement of mesh. Last year, close to 100,000 POP repairs completed with the use of surgical mesh. Approximately 75,000 of those were transvaginal procedures.
- Approximately 1500 reports associated with the surgical placement of mesh used in POP from 2008 to 2011 have been reported to the FDA.
- Some complications reported from the use of surgical placement of mesh include: bleeding, infections, organ perforation, urinary problems, mesh becoming exposed and pain during sexual intercourse.
- FDA first issued a safety warning about the surgical placement of mesh in 2008. Since this first warning, the number of events has continued to increase. FDA suggested that many patients who undergo transvaginal POP repair with surgical placement of mesh are exposed to additional risks in comparison to patients who have POP repair with stitches.
What you need to do:
If you have not had surgery already: FDA recommends you to ask your surgeon before surgery about all POP treatment options and understand why the surgeon may be recommending treatment of POP with mesh. (Ask your surgeon about the treatment options that do no involve mesh.)
If you have had surgery: If you have already had POP surgery and do not know whether your surgeon used the surgical placement of mesh, contact your surgeon.
After surgery, continue with follow-up care after surgery and routine check-ups. If you have any complications, notify your surgeon immediately.