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 Clinica

Executive Summary

Existing manufacturers of transvaginal surgical mesh for pelvic organ prolapse procedures, including Boston Scientific Corp., ACell Inc., Coloplast AS, and American Medical Systems Holdings Inc., will have to file for PMAs in 30 months to keep their mesh products on the markets, says FDA in a Jan. 4 final order.

You may also be interested in...



Study Says FDA Waited Too Long To Ban Pelvic Mesh For POP Repairs

Roughly 18.5% of patients who received reinterventions to fix mesh implants for pelvic organ prolapse (POP) repair experienced complications they will likely endure for the rest of their lives, and they also face a 2.5% higher rate of further surgeries than non-mesh patients, says a recent 54,194-woman study detailed in Obstetrics & Gynecology. The study authors lay out a case that the US FDA should have forced removal of mesh from the market sooner.

'A Criminally Negligent Medical Device Regulatory System': UK Mesh News Provokes Outrage

The EU medtech regulatory system is coming under fire again in the UK, being blamed for the vaginal surgical mesh scandal as action is taken to limit procedures. But this is a global problem.

Biogen Doubles Down On Alzheimer’s and Neuroscience With Sangamo Gene Regulation Deal

As sector awaits its aducanumab filing with bated breath, Biogen invests again in early stage neuroscience.

Topics

UsernamePublicRestriction

Register

MT103108

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