522 Post-Market Clinical Studies

Boston Scientific has completed enrollment in all three 522 post-market clinical studies as originally committed following the Food and Drug Administration (FDA) Safety Notifications related to transvaginal mesh.
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence (Solyx™ Single Incision Sling)
Multi-center Study of Uphold LITE Versus Native Tissue for the Treatment of Women With Anterior/Apical Pelvic Organ Prolapse (Uphold LITE Vaginal Support System)

Xenform Postmarket Surveillance Study (Xenform Soft Tissue Repair Matrix)

For more information, visit the U.S. National Institute of Health’s registry and results database of publicly and privately supported clinical studies, www.clinicaltrials.gov.

Additional Clinical Research

Boston Scientific actively partners with leading researchers in two large-scale clinical projects.
Pelvic Floor Disorders Registry (PFDR) – In support with the American Urogynecological Society (AUGS) and other industry partners, Boston Scientific is part of a national patient registry to evaluate the effectiveness, quality of life and safety associated with native tissue repair and mesh repair.
SUPeR study – Boston Scientific has contributed funding to a randomized, blinded study to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse. The SUPeR study is conducted by the Pelvic Floor Disorders Network (PFDN), a multi-center network of the National Institute of Child Health and Development (NICHD).

Clinical Resources