AMS Transvaginal Mesh Lawsuits Lead to TVM Safety Studies
In the midst of a number of transvaginal mesh lawsuits, American Medical Systems (AMS), a subsidiary of Endo Pharmaceuticals responsible for manufacturing the company’s transvaginal mesh devices, has enrolled several hundred patients in the Embrace program, a new study on the safety and efficacy of the Elevate anterior and apical prolapse transvaginal mesh system.
At the end of April 2014, the Food and Drug Administration (FDA) responded to thousands of patient complaints and personal injury lawsuits by announcing that the regulatory agency would require new safety tests on transvaginal mesh devices. AMS is the first company to announce safety testing for its transvaginal mesh devices.
The new safety guidelines would prohibit transvaginal mesh manufacturers from using the 510(k) process to fast-track approval of their devices. The 510(k) regulation allows medical devices that are structurally similar to previously-approved devices to get on a “fast-track” approval process to get to market faster. Transvaginal mesh manufacturers have used this process based on a Gynecare ProLift device, which was approved in 1996, but then recalled due to safety problems in 1999. A number of transvaginal mesh lawsuits have been filed related to life altering side effects including erosion, pain, painful intercourse, and recurring infection.
Dr. Eric Sokol, Co-Chief, Urogynecology and Pelvic Reconstructive Surgery at Stanford University School of Medicine, has agreed to be the principal investigator for the AMS Embrace study. AMS anticipates that the company will enroll 494 patients in the post-market transvaginal mesh study at approximately 40 sites in the US. The pharmaceutical manufacturer is also planning a second study, called Harmony, that will enroll an additional 494 patients at 40 sites across the country. Embrace should take an estimated 2 years, while Harmony will take 3, for a total of 5 years of study into transvaginal mesh’s efficacy – each a significantly longer study than other transvaginal mesh clinical trials.
“Pelvic organ prolapse is often complex. 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. The Embrace study will provide valuable information to clinicians and patients about the role of mesh for the treatment of female pelvic organ prolapse,” said Dr. Sokol.
“These studies demonstrate the commitment of AMS to provide medical evidence that further validates the safety and efficacy of our products,” said Camille Farhat, president of American Medical Systems. “As a global leader in Women’s Health, we will continue to invest in the science that supports these therapies and maintain our support of robust physician training as well as patient education that encourages conversations about the risks and benefits of these treatments.”
The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Case
Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, vaginal mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapse, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800