Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA mulls upping risk classification of vaginal mesh as lawsuits mount up for big mesh makers

This article was originally published in Clinica

Executive Summary

Transvaginal meshes to treat pelvic organ prolapse may soon be classified as "high-risk" devices requiring premarket approval, pending the outcome of a two-day US FDA panel meeting to discuss the safety and efficacy of the products. These meshes, made by the likes of Johnson & Johnson and CR Bard, were previously regulated under the less-stringent 510(k) procedures. However, growing concern over serious complications arising in patients implanted with the devices have prompted calls for stricter regulation.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT097863

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel