Boston Scientific : Perspective on “60 Minutes” Transvaginal Mesh Segment

At Boston Scientific, our top priority is ensuring that all our products are safe and effective. We remain steadfast in our commitment to women's health.

We disagree with the conclusions in the recent '60 Minutes' story on transvaginal mesh and believe it lacked context critical for a balanced discussion on the treatment of pelvic organ prolapse and stress urinary incontinence.

While others exited the pelvic mesh market, we made the decision to continue to provide our products because if we stopped, patients would be left with few treatment options. Our pelvic mesh products contribute to only one percent of sales for Boston Scientific annually, so clearly this is about what doing what is right for patients.

The majority of patients have benefitted from our innovations and we remain dedicated to offering safe and effective products to help treat these and other debilitating conditions. We have and will continue to do what is right for patients.

One in three women globally is affected by a pelvic floor disorder. These conditions are debilitating and often embarrassing, yet few treatment options exist.

All of our products meet rigorous internal safety standards as well the standards of the FDA and other regulatory bodies. Leading physician societies have issued supporting statements on mesh, such as one by a task force of the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction.

We recognize that it is in the best interest of all to ensure that products are properly tested, safe and effective for patients who need them. The allegations that the resin used in our products is counterfeit have already been proven false. The FDA determined after a thorough review concluding in September 2017, that the change in our resin supplier did not raise any new safety or effectiveness concerns.

We continue to invest in studies to provide the medical community with additional clinical evidence to support ongoing treatment decisions. There are more than 60 clinical publications available in support of our pelvic floor products. We currently have three 522 post-market clinical studies ongoing in the U.S. There are an additional 14 investigator-sponsored research studies on our pelvic floor products underway.