September 20, 2011 (CHARLESTON, SC)—Nancy Muller, PhD, executive director of NAFC presented NAFC’s position statement concerning vaginal mesh for pelvic surgery, at the open public hearing for the Obstetrics and Gynecology Devices Panel of the Food and Drug Administration (FDA).

In July, the FDA issued an updated safety communication warning that the use of surgical mesh to repair pelvic organ prolapse (POP) may subject patients to greater risk of complications than other surgical options, without sufficient benefit. The purpose of this hearing was to provide recommendations to the FDA’s obstetrics and gynecology devices panel on regulatory issues for the continued use of surgical placement of vaginal mesh. Testimonies from leading clinical authorities clearly established that mesh slings for stress urinary incontinence (SUI) in women are considered the gold standard by which all future procedures and devices should be measured. Success rates are higher and complications are fewer than with traditional tissue-to-tissue procedures. Because of their relative newness on the market, “mini” slings involving only single incisions and less synthetic polypropylene materials beg for additional post-market surveillance data. Mesh kits used for POP repair offer less decisive clinical data and may be superior in durability for some types of repairs over others, despite the higher rate of post-operative complications, many less serious than others. However, more research data is needed to reach definitive conclusions regarding mesh for POP.

NAFC’s position statement focuses on fuller, conversational informed consent for a patient undergoing surgery for POP or SUI. Conversations between the patient and her doctor must be central to the process and take place well in advance of reaching a decision for intervention. Relationships between the physician and industry must be transparent and revealed in communication with the patient. Click here to read NAFC’s six-part position statement.

To assist physicians and industry with further informed consent in the shared decision making process with patients, NAFC has added a new section to its website dedicated to this consumer training and education and is providing an educational webinar available for consumers and health care professionals during Bladder Health Week, November 14-18, 2011, content of which will be permanently archived on www.nafc.org. New patient handouts are also available for professional members of NAFC.