FDA sets new rules for injury-prone pelvic mesh

Mesh implants used to repair pelvic collapse in women will face new federal scrutiny, under rules responding to thousands of injuries reported with the problem-prone devices.

The Food and Drug Administration says makers of pelvic mesh must submit data showing the safety of their products, following years of reports of pain, bleeding and infection among women receiving the implants. The new requirements do not apply to mesh products used to treat conditions like hernias or incontinence.

The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than who undergo with stitches. Mesh products were introduced for pelvic repair in the 1990s as a high-tech improvement to surgery, but FDA said there is no evidence they improve outcomes.

© 2016 The Associated Press. All rights reserved.

Citation: FDA sets new rules for injury-prone pelvic mesh (2016, January 4) retrieved 29 March 2023 from https://medicalxpress.com/news/2016-01-fda-injury-prone-pelvic-mesh.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

Explore further

FDA wants stricter safety rules for pelvic mesh


Feedback to editors