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Transvaginal Mesh is High Risk – FDA Provides Recommendations

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

Today the FDA advised that transvaginal mesh fails to provide any benefit to women and changed the mesh’s classification toHIGH RISK. In its previous safety alert, the FDA provided guidelines for women who are about to undergo surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI) and for women who have already had mesh implanted transvaginally to treat POP or SUI. These guidelines are now even more important to women due to the new HIGH RISK classification of transvaginal surgical mesh.

The FDA recommends that before undergoing transvaginal placement of surgical mesh a woman should do the following:

  • Be aware of the risks associated with transvaginal POP repair.
  • Know that having a mesh surgery may increase the risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
  • Ask their surgeons about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why their surgeons may be recommending treatment of POP with mesh.

After undergoing surgery to transvaginally implant surgical mesh, the FDA recommends doing the following:

  • Continue with annual and other routine check-ups and follow-up care. Patients do not need to take action if they are satisfied with their surgery and are not having complications or symptoms.
  • Notify their health care providers if they develop complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after the last follow-up appointment.
  • Let their health care providers know if they have surgical mesh, especially if planning to have another related surgery or other medical procedures.
  • Talk to their health care providers about any questions or concerns.
  • Ask their surgeons at their next routine check-up if they received mesh for their POP surgery if they do not know if mesh was used.