Johnson & Johnson ETHICON Women’s Health & Urology, a worldwide leader in surgical care, has announced its decision to cease sales and production of four GYNECARE products. The products that will be discontinued include:

• GYNECARE PROSIMA™ pelvic floor repair system used in pelvic organ prolapse surgery
• GYNECARE PROLIFT® pelvic floor repair system used in pelvic organ prolapse surgery
• GYNECARE PROLIFT +M™ pelvic floor repair system used in pelvic organ prolapse surgery
• GYNECARE TVT SECUR™ system used for stress urinary incontinence surgery

The discontinuation of these ETHICON products and such decisions by other companies to remove mesh products from the market are commercial decisions based on the high cost of conducting and collecting additional research data. The decisions aren’t due to safety violations or lack of product effectiveness, but by the new demands from the FDA for additional data on products and already approved by the FDA for use on the market. The discontinuation of the four GYNECARE products is not due to a voluntary or mandatory recall by ETHICON or the FDA. ETHICON informed the FDA and other worldwide health regulatory authorities of the decision Monday, June 5, 2012.

To learn more read NAFC's Special Edition Issue of Quality Care® Monthly.