Boston Scientific’s View On Vaginal Mesh Safety

On February 12, 2019, the U.S. Food and Drug Administration (FDA) convened a general issues advisory panel of experts to discuss the safety and effectiveness of transvaginal surgical mesh to treat pelvic organ prolapse (POP). Patient safety is always our highest priority, and we appreciate the panel’s scientific and clinical input. Please see our statement here.

Our mesh products meet rigorous internal safety standards as well the standards of the FDA and other regulatory bodies, and international standards. We are dedicated to using quality materials in all of our medical products and have tested them extensively.
The importance of having treatment options has recently been commented on by the American Urogynecological Society, an authority on the treatment of women’s pelvic health.i Read the statement AUGS submitted to the FDA on the panel meeting  by clicking here.
Polypropylene material has been used in medical procedures for more than 50 years, including in hernia repair and surgical sutures.ii This material has been used in millions of patients and by surgeons worldwide.iii
 

Information for patients

Urogynecological mesh made with polypropylene may be an effective treatment option for women living with stress urinary incontinence and pelvic organ prolapse. Nearly one million women have been successfully treated with Boston Scientific’s mesh.

 

Information for physicians

We know that recent media reports about mesh may have been concerning to you and your patients.

 

A message from CEO Mike Mahoney

Patient health, safety and peace-of-mind are what matters to us at Boston Scientific. Recent news media may have been worrisome to women who have urogynecological mesh implants, or may be considering them to treat pelvic floor disorders. Our goal is to answer your questions and provide accurate information. Hear more about the facts on our mesh products from our Chairman and CEO, Mike Mahoney.

i. AUGS/SUFU Joint Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence. 2014; updated 2016 and 2018. https://www.augs.org/assets/1/6/AUGS-SUFU_MUS_Position_Statement.pdf
ii. Gilbert A., Graham M., Young J. (2004) Polypropylene: the Standard of Mesh Materials. In: Schumpelick V., Nyhus L.M. (eds) Meshes: Benefits and Risks. Springer, Berlin, Heidelberg, pg. 102
iii. Gilbert A., Graham M., Young J. (2004) Polypropylene: the Standard of Mesh Materials. In: Schumpelick V., Nyhus L.M. (eds) Meshes: Benefits and Risks. Springer, Berlin, Heidelberg, pg. 102
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