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September 7th, 2011

Cook Medical Supports the FDA’s Evaluation of Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, but Urges Further Analysis

Bloomington, Ind. — Cook Medical supports the FDA’s efforts to protect women’s health and its review of the issues surrounding the use of surgical mesh for the treatment of pelvic floor disorders. We commend the FDA’s support of open scientific discussion of the effectiveness of transvaginal surgical mesh placement for pelvic organ prolapse repair.

Cook is aware of the risks associated with the use of synthetic materials to repair the pelvic floor while also recognizing that important differences exist between synthetic mesh products and biologic grafts in terms of tissue response, risks, and successful clinical outcome. A detailed review of the published clinical literature, which has been submitted to the FDA, provides compelling evidence for the safety of the more recently available non-crosslinked biologic grafts, such as those supplied by Cook and other companies. Cook encourages the FDA and the Obstetrics and Gynecology Devices Panel to consider this evidence when deliberating on possible recommendations concerning the use of synthetic mesh products or biologic grafts to treat pelvic organ prolapse.

“Our number one priority is keeping patients safe while also improving their quality of life,” said Andy Cron, vice president of Cook Medical’s Surgery division. “Cook has and continues to work with physicians to develop surgical procedures and advanced materials that provide a lasting repair without a permanent synthetic mesh.”

Read Cook’s letter to the FDA Obstetrics-Gynecology Panel.

Read Cook’s literature review of Pelvic Organ Prolapse Products.

About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation.

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