American Medical Systems (AMS), a subsidiary of Endo International, enrolled the first patient in its mandatory post market surveillance study for the Elevate™ Anterior and Apical Prolapse Repair System. The study is being conducted after the U.S. Food and Drug Administration (FDA) required all transvaginal mesh manufacturers to conduct post market surveillance studies. The purpose is to compare the risks versus benefits of TVM products currently on the market.
The study will involve approximately 494 patients from 40 different locations throughout the U.S. It will compare the Elevate Anterior and Apical Prolapse Repair System with a native tissue repair control group.
“The Embrace study will provide valuable information to clinicians and patients about the role of mesh for the treatment of pelvic organ prolapse,” said Dr. Eric Sokol, Co-Chief of Urogynecology and Pelvic Reconstructive Surgery at Stanford University School of Medicine, in an article. Dr. Sokol is also the primary investigator for the Embrace study.
The study is expected to take two years to enroll participants and an additional three years to follow for a total length of five years.
Used to treat women suffering from pelvic organ prolapse (POP), transvaginal mesh has been linked to serious health complications that may require additional follow-up surgeries. Some women with TVM implants have experienced complications that include:
- Mesh erosion
- Organ perforation
- Urinary problems
The lawyers at Simmons Hanly Conroy are currently investigating claims for women who have suffered complications from a transvaginal POP repair with mesh.