Coloplast Vaginal Mesh Postmarket Data Shows Similar Safety To Native Tissue Repair

The company’s review of patient safety data found similar adverse event rates between patients treated with transvaginal mesh and those treated surgically. However, the FDA still says the benefits of the treatment do not outweigh its risks

3D illustration of the number 522 against a maroon background.
• Source: Shutterstock

Women who were treated for pelvic organ prolapse (POP) using Coloplast Ltd. transvaginal mesh experienced similar outcomes at 36 months to those treated with native tissue repair, the US Food and Drug Administration said on 17 October.

The data came from a postmarket 522 study that the FDA ordered in 2012 as part of its investigations...

More from Regulation

More from Policy & Regulation

Global Medtech Guidance Tracker: June 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By 

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.