From the Desk of the President – FDA Announces Decision on Transvaginal Surgical Mesh
FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
Yesterday April 16, 2019, the U.S. Food and Drug Administration issued an order to the manufacturers of all remaining transvaginal surgical mesh products for POP repair to immediately stop selling and distributing their product in the U.S. These manufacturers and their products are:
- Boston Scientific
- Uphold LITE Vaginal Support System
- Xenform Soft Tissue Repair System
- Restorelle DirectFix Anterior
This action is a result of the FDA’s series of escalating safety actions related to transvaginal mesh over the past several years, beginning in July 2011 with an FDA Safety Commutation, then to the January 2016 reclassification of these devices to the highest risk class (class III), and concluding with the February 2019 advisory committee meeting which precipitated this decision. The companies now have 10 days to inform the FDA of their plan on how they will remove these products from the market; however, they are still required to continue the studies they have been conducting since 2016 with follow-up of enrolled subjects who have received these transvaginal mesh products for the POP repair.
What does this mean for your patients that have had transvaginal mesh placed previously? Patients should continue with their normal annual care routine in regard to their POP repair. If they are not having any complications or symptoms, nothing additional needs to be done. If they are experiencing complications or symptoms, they should discuss other treatment options with you and/or their other gynecologic health care provider.
What does this mean for you? Since these transvaginal mesh products will no longer be available on the market, you’ll need to begin discussing alternate treatment options for your patients that require surgical repair of POP.
Please note: midurethral slings and mesh for sacrocolpopexy are not included in this recommendation, so it is important that there are no misunderstandings regarding this communication. Sling devices and sacrocolpopexy mesh implants will remain on the U.S. market.
I encourage you to read the entire FDA announcement by clicking on the button below.