The U.S. Food and Drug Administration (FDA) warned TVM manufacturer American Medical Systems after a recent facility inspection. The warning came after the agency found problems with the company’s TVM device risk analysis and manufacturing process validation procedures.
American Medical Systems Responds to FDA Warning Letter
The FDA completed inspection on the American Medical Systems plant in Minnetonka, MN on February 2014. Then on April 10, 2014, the FDA sent a letter to Endo Health Solutions (American Medical Systems’ parent company). According to a U.S. Securities and Exchange Commission (SEC) filing on April 16, 2014, American Medical Systems plans to take corrective action. However, the FDA will conduct a follow-up inspection to verify these corrections.
Thousands of Women Sue AMS Over TVM Injuries
American Medical Systems faces thousands of lawsuits from women who needed transvaginal mesh removal surgery due to life-threatening complications. In fact, AMS already settled around 17,000 transvaginal mesh lawsuits. Plaintiffs received TVM implants for pelvic organ prolapse (POP) as well as stress urinary incontinence. Often, these devices lead to issues that may leave women infertile.
The first American Medical Systems bellwether trial happens on June 2, 2014.
What Women with TVM Injuries Can Do
If you needed mesh removal surgery due to complications, you may be eligible for a cash settlement. To see if you may qualify for financial compensation, fill out your free TVM claim evaluation form now. Once you’ve submitted your information, an experienced attorney will call you. You can then set up an in-person consultation to review your compensation options face to face.
Related: Find Your State’s Deadline to File an Injury Claim
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.