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

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

Executive Summary

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.

You may also be interested in...



New Zealand Follows Australia’s Lead In Banning Urogynecological Mesh

Surgical mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation will no longer be supplied in New Zealand, Medsafe says.

FDA Moves Mesh Surgical Instrumentation Up To Class II In Final Order

The US agency has agreed with an earlier assessment by an advisory panel last year to up-classify surgical mesh instrumentation by issuing a Jan. 6 final order to move the instrumentation – used for women undergoing pelvic organ prolapse or female stress incontinence procedures – from class I to class II.

PMA Mandate Set For Pelvic Organ Prolapse Transvaginal Mesh

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.

Topics

UsernamePublicRestriction

Register

MT122953

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