Patient Advocacy Organizations Seek Patient Stories for Upcoming FDA Hearing
CHICAGO, Aug. 17, 2011 /PRNewswire-USNewswire/ -- Women's Health Foundation (WHF), in collaboration with the Association for Pelvic Organ Prolapse Support (APOPS) announced today that they will be representing female patients' stories who have undergone transvaginal mesh surgical treatment for pelvic organ prolapse at an upcoming FDA meeting in Washington, D.C. This meeting is in response to the FDA's recent public health notification warning regarding the safety of transvaginal mesh.
Pelvic organ prolapse is when one or more of the pelvic organs including the uterus, vagina, bladder, or rectum, fall down or slip out place. Twenty to 30 percent of women suffer from some degree of prolapse, according to estimates from Brigham & Women's Hospital. Approximately 300,000 women undergo surgery each year for pelvic organ prolapse in the United States, according to the American Urogynecological Society.In 2008, the FDA first released concerns about the safety of transvaginal placement of mesh. From 2008 to 2010, the FDA received five times as many adverse reports associated with mesh used for POP repair than what agency received from 2005 to 2007.
"As advocates for patients with pelvic floor disorders, it's important for us to be a voice for women who have found relief from this particular treatment along with those who have reported complications," said Missy Lavender, Founder of Women's Health Foundation. "Any surgical procedure is risky, it's important that patients have a knowledge base of the 'what if's' and have exhausted other less invasive treatment options."
"It is imperative that women do their homework when evaluating options for treatment of pelvic organ prolapse. Transvaginal mesh procedures play a pivotal role in preventing additional surgical intervention down the road but it is vital that they are performed by physicians who have been adequately trained," said Sherrie Palm, Founder and President of the Association for Pelvic Organ Prolapse Support.
"Mesh reinforcement is just one 'tool' in today's surgical toolbox, which may be recommended in select cases as an option intended to achieve a more durable surgery, or even to avoid the need for hysterectomy in some cases." said Dr. Roger Goldberg, Clinical Assistant Professor at the University of Chicago Pritzker School of Medicine and Urogynecologist at Northshore University Health System in Evanston, IL. "What's critical is whether or not the surgeon performing the procedure has the proper training. Choosing the right prolapse surgery is no different than boarding an airplane: you need to align yourself with a pilot who is experienced and confident in a variety of techniques," Dr. Goldberg added.