The FDA’s April 16, 2019 announcement ordering manufacturers to stop selling and distributing certain transvaginal mesh products has caused concern and confusion for physicians who use mesh products for the repair of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
The FDA order applies only to surgical mesh manufactured for the transvaginal repair of anterior prolapse. 1 It specifically pertains to three products manufactured by Boston Scientific (Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System) and Coloplast (Restorelle DirectFix Anterior).
The FDA order does not apply to the use of mesh midurethral slings for the treatment of stress urinary incontinence or to mesh used in the transabdominal repair of anterior prolapse. The American Urogynecologic Society (AUGS) continues to support the use of mesh midurethral slings as a standard of care for the surgical treatment of SUI. 2
Despite the narrow scope of the FDA’s order, the announcement inflames the furor and litigation surrounding the use of mesh. Physicians should be extra diligent in employing and documenting a detailed consent process when any type of mesh repair is contemplated.
Patients should be made aware of the FDA’s activities regarding mesh for urogynecologic repairs, including its April 16, 2019 order. 3 Patients should be fully informed of the following:
- the controversy surrounding the use of mesh;
- information regarding alternative treatments without mesh;
- the risks, benefits, and complications associated with the use of mesh;
- the fact that mesh is a permanent implant; and
- that limited information is available regarding long-term outcomes.
The FDA has published recommendations for health care professionals using mesh for the treatment of SUI, including information to be discussed when obtaining informed consent. 4 These recommendations should be incorporated into any informed consent process involving mesh for urogynecologic repairs.
Patients with transvaginal mesh may be alarmed by the FDA’s announcement. Advise these patients that the FDA has stated that women who have received transvaginal mesh for POP should continue with routine follow ups. No other action is necessary if they have no other symptoms and are satisfied with their surgery.1
These patients should also be advised to notify their physicians if they have any symptoms such as vaginal bleeding or discharge, pelvic/groin pain, or pain with sex. They should also tell their health care professionals that they have surgical mesh implanted, especially if having surgery or other medical procedures.1
- U.S. Food and Drug Administration. Urogynecologic surgical mesh implants. April 16, 2019. Available at https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants. Accessed May 20, 2019.
- American Urogynecologic Society. FDA announcement on transvaginal mesh for prolapse. April 18, 2019. Available at https://www.augs.org/fda-announcement-on-transvaginal-mesh-for-prolapse/ . Accessed May 20, 2019.
- U.S. Food and Drug Administration. FDA's activities: Urogynecologic surgical mesh. April 16, 2019. Available at https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh . Accessed May 20, 2019
- U.S. Food and Drug Administration. FDA’s recommendations for health care providers treating stress urinary incontinence. Available at https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/recommendations-health-care-providers-treating-stress-urinary-incontinence. Accessed May 20, 2019.