The FDA’s warning letter was sent to American Medical Systems April 10, 2014, and warns that FDA investigators found that a facility run by the company had issues involving risk analysis and other problems. Although the transvaginal mesh is not specifically listed in the products affected by the risk analysis and other quality control issues, the FDA notes “other urological health products” in its letter.
AMS noted in its Securities and Exchange Commission (SEC) filing (dated April 16, 2014) that it had received the warning letter, was drafting a response and was implanting a corrective action plan “as agreed with the FDA.”
Lawsuits have been filed against AMS alleging women were harmed by the company’s transvaginal mesh device. The mesh devices, made by a variety of companies, are designed to treat pelvic organ prolapse. Among reported complications of transvaginal mesh devices are mesh erosion, scarring, pain and infection. In some cases, women who had the devices implanted reportedly required surgery to remove the mesh.
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Concerns about the devices are great enough that the FDA recently required that post-market surveillance studies be conducted by all transvaginal mesh manufacturers.
As a result, American Medical Systems has begun enrolling patients in its Embrace study for the Elevate Anterior and Apical Prolapse Repair System. According to American Medical Systems, the study is a large, multi-center cohort-controlled study to compare the repair system with a “native tissue repair control group.” In all, almost 500 patients will be included in the Embrace study and another 500 in another study on the Harmony repair system.
The studies are expected to take two years to enroll patients and three years of follow-up, providing five years of data.