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FDA orders manufacturers of surgical mesh intended to treat pelvic organ prolapse, to stop distribution immediately

On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016. 

Surgical mesh has been used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed with surgical mesh to treat pelvic floor disorders with surgical mesh:

  • Transvaginal mesh to treat POP *
  • Transabdominal mesh to treat POP
  • Mesh sling to treat SUI

Each of these procedures has unique risks and benefits and it is important not to confuse the procedures and their risks and benefits.

Women who have received transvaginal mesh for the surgical repair of prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms. You should notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex. 

Visit the FDA Website For More Information