FDA stops sale of surgical mesh for transvaginal repair of pelvic organ prolapse in the US

Earlier this month, the US Food and Drug Administration (FDA) ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately.

The FDA had reclassified these mesh products as class III (high risk) in 2016 and the manufacturers, Boston Scientific and Coloplast, were not able to comply with the premarket review standard that now applies to them as they could not provide enough evidence as reasonable assurance of their safety and effectiveness. The companies will have 10 days to submit their plan to withdraw these products from the market.

In 2002, the first mesh device for transvaginal repair of POP was cleared for use as a class II moderate-risk device.

A practice advisory issued by the American College of Obstetrics and Gynecology (ACOG) in response to the FDA announcement specified that the FDA announcement applies only to mesh placed vaginally to treat POP. The FDA order does NOT apply to transvaginal mesh for stress urinary incontinence. Additionally, the FDA order does not apply to mesh placed abdominally (sacrocolpopexy via laparotomy or endoscopy) for prolapse repair.

(Source: US FDA, ACOG)

Be the first to comment

Leave a Reply

Your email address will not be published.


*