FDA Orders Immediate Stop on Commercialization of Surgical Mesh for Women with Pelvic Collapse in the US

Shots:

• The US FDA has ordered all medical device manufacturers including Boston Scientific and Coloplast to stop sales & distribution of surgical mesh for the transvaginal repair of pelvic organ prolapse (POP) for the protection of women’s health
• The PMA submitted failed to provide long term assessment of safety & benefits compared to transvaginal surgical tissue repair without the use of mesh and FDA has reclassified them in class III (high risk) since 2016. The companies have 10 days for the submission of withdraw plans from the US markets
• In 2002, the first mesh device was identified as class II moderate-risk device for transvaginal repair of POP in women

Click here to read full press release/ article | Ref: US FDA | Image: Twitter