Posted in NEWS, NEWS on urogenital system implants

FDA stops sales of urogynecologic surgical mesh implants

16 April 2019

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.

Women who have received transvaginal mesh for the surgical repair of pelvic organ 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. You should also let your health care provider know if you have surgical mesh, especially if you plan to have another surgery or other medical procedures. If you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, you should discuss other treatment options with your doctor. If you have had pelvic organ prolapse surgery but do not know whether your surgeon used mesh, ask your surgeon at your next scheduled visit. Additional information for patients and health care providers about the use of surgical mesh for transvaginal pelvic organ prolapse is provided in this websection.
Author(s)	Source
FDA	FDA website, update 07 Oct 2019
This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register.
Comments: n/a let us know