Medtech Insight is part 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

PMA Mandate Set For Pelvic Organ Prolapse Transvaginal Mesh

This article was originally published in The Gray Sheet

Executive Summary

FDA issued final orders up-classifying surgical mesh for transvaginal repair of pelvic organ prolapse from class II to class III and calling for PMA standards, including clinical trial, animal studies, and materials testing data from new and existing manufacturers.

You may also be interested in...



FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan

Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.

US FDA Advisory Committee Recommends 3-Year Benefit-Risk Reviews For Pelvic Mesh

An FDA advisory committee recommended Feb. 12 that US FDA take up to three years to assess the benefits and risks of pelvic mesh, and that product labels call for experienced surgeons only for implantations, if any new mesh products for transvaginal repair of pelvic organ prolapse (POP) are approved. Meanwhile, public-health groups said ongoing PMA applications for current mesh products should be rejected, given the large number of reoperations and adverse events associated with the use of mesh.

Endo Unit Shutdown Could Strand Incontinence Treatment Praised By FDA Panel

Endo International plans to shutter its Astora Women's Health business unit – formerly part of American Medical Systems – this month due to ongoing legal concerns tied to the company’s vaginal mesh products. What’s unclear is what this means for the company’s investigational fecal incontinence treatment, which received unanimous support from an FDA advisory panel just days before the shutdown was announced.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT034762

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