Endo International PLC., parent company of American Medical Systems (AMS), recently received a warning letter from the U.S. Food and Drug Administration (FDA). After inspecting the transvaginal mesh manufacturer’s facility, the FDA found three federal regulation violations. The agency cited both urological device and transvaginal mesh manufacturing violations. Warnings included in the letter mentioned process validation, risk analysis and preventive action procedures.
Transvaginal Mesh Manufacturer AMS Faces Thousands of Device Injury Lawsuits
According to Twin Cities Business magazine, the FDA asked the transvaginal mesh manufacturer to accelerate fixing identified problems in February. Then in March, AMS said the transvaginal mesh manufacturer created its action plan. However, the company received the letter on April 14, 2014, which stated that AMS’s plans to correct issues seem adequate but because actions have not been completed, regulators will need to conduct a follow-up inspection.
The source also noted that AMS is reportedly facing thousands of lawsuits due to safety issues concerning their vaginal mesh products.
Sources say that in these cases, the plaintiffs allege issues with the AMS vaginal mesh devices design as well as the company’s failure to properly test the products for safety, even though there’s a legal duty to protect against dangerous design flaws. If there is a problem, AMS is obligated to quickly warn and protect consumers.
AMS is working on its response to the FDA’s letter and continues to put into action its corrective plan. According to Twin Cities Business magazine, the company said, “AMS is committed and expects to continue to make significant progress during the remainder of 2014, with completion of the proposed corrective actions expected to occur by the end of 2015.”
What You Can Do
Anyone injured by an AMD transvaginal mesh device should get a free TVM claim evaluation immediately. You may qualify for financial compensation from AMS or another transvaginal mesh manufacturer. After submitting your information, an attorney in your area will call to discuss your cash settlement options.
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.