Statement of Dr. Diana Zuckerman on FDA’s proposed order for pelvic mesh

Statement of Dr. Diana Zuckerman, President

April 30, 2014

 

We strongly support the FDA’s proposed order to require proof of safety and effectiveness of surgical mesh for pelvic organ prolapse (POP) in clinical trials. Doesn’t that seem like something the FDA should have required years ago, before it was implanted in hundreds of thousands of women?

We disagree with the FDA decision to continue to allow surgical mesh to be sold for the treatment of incontinence without clinical trials to assure safety and effectiveness. Every year, more than 200,000 women have mesh implanted as part of surgery to reduce stress incontinence. The same terrible side effects are possible when mesh is used for either POP or incontinence, and women deserve clear scientific evidence of the safety of mesh for all purposes, not just POP.