AMS Gears Up for Transvaginal Mesh Safety Studies

Published on June 27, 2014 by Sandy Liebhard

American Medical Systems has enrolled the first patient in a study involving transvaginal mesh implants associated with chronic pain, pain during sexual intercourse and other complications in thousands of lawsuits filed in the U.S., according to MarketWatch.com.

A recent article indicates that the Endo International plc subsidiary announced the launch of its Embrace ™ study on June 9th, which is set to begin with a patient supplied by a doctor from New Jersey’s Center for Specialized Women’s Health at the Division of Garden State Urology. The research will involve the AMS Elevate Anterior and Atypical Prolapse Repair System, and follows a past order from the U.S. Food and Drug Administration (FDA) that AMS and several other mesh manufacturers conduct post-market safety studies for its products. The Co-Chief of Urogynecology and Pelvic Reconstructive Surgery at Stanford University School of Medicine will be helping lead the Embrace study, and compare both devices with a native tissue repair control group. Thousands of vaginal mesh lawsuits have been filed by women who received devices involved in this research, according to court records.

AMS to Conduct Two Transvaginal Mesh Studies over Five Years

“Pelvic organ prolapse is often complex,” he said. “Multiple treatment options are needed to address the exact nature and complexity of the prolapse and there are particular circumstances when the placement of transvaginal mesh may be beneficial and appropriate.”

According to MarketWatch, the Embrace study will involve 494 patients from 40 sites in the U.S. This will be first of two projects conducted by AMS, the second involving its Elevate Posterior and Apical Prolapse Repair System. The Harmony ™ study will also involve 494 patients at 40 locations in the U.S., and will take place over a period of five years. The enrollment period will go on for two years, and will continue for another three. The Harmony and Embrace studies are some of the longest involving transvaginal mesh.

In addition to pelvic mesh marketed by AMS, products from Boston Scientific Corp., the Johnson & Johnson subsidiary, Ethicon and C.R. Bard have been scrutinized for their potential to cause serious complications.