FDA Sends Warning Letter to Transvaginal Mesh Manufacturer American Medical Systems, National Law Firm Baron and Budd Reports

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Letter Cited Several Issues Found After Inspection of Company’s Minnesota Plant

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The national law firm of Baron and Budd reports that the Food and Drug Administration (FDA) issued a warning letter to American Medical Systems, a manufacturer of transvaginal mesh devices. The letter was in regard to issues the FDA found at a facility run by the company, including procedures involving risk analysis and process validation procedures. The parent company of American Medical Systems, Endo Health Solutions, Inc., disclosed the letter in a filing with the U.S. Securities and Exchange Commission (SEC) on April 16. (http://www.sec.gov/Archives/edgar/data/1593034/000119312514144986/d711537d8k.htm)

The FDA sent the letter to Endo Health Solutions on April 10 following a February inspection of an American Medical Systems manufacturing plant in Minnetonka, Minnesota. According to the SEC filing, American Medical Systems has submitted a plan to take corrective action to address the issues. However, according to the letter, the company’s facility will be subject to a follow-up inspection in order to ensure the necessary corrections have been made.

American Medical Systems has been the target of thousands of lawsuits filed by users of their transvaginal mesh devices. The company has been named as a defendant in approximately 17,000 transvaginal mesh lawsuits filed by women who say they have suffered serious and painful complications after using AMS devices, which are designed to treat pelvic organ prolapse and stress urinary incontinence. Serious organ damage, significant pain and several other alleged complications have been reported. (http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm)

The first bellwether trial involving an American Medical Systems case is scheduled to begin on June 2, 2014. (In Re American Medical Systems, Inc. - MDL No. 2325). National law firm Baron and Budd co-founder and shareholder Russell Budd serves on the Plaintiffs’ Steering Committee for transvaginal mesh litigation.

“We applaud the diligence of the FDA in closely scrutinizing the operations of the American Medical Systems facility,” said Stephen Blackburn, attorney at Baron and Budd. “Our firm will keep a close eye on these and other developments in order to provide the best possible legal representation to our clients who have suffered terribly due to transvaginal mesh devices.”

Please contact the national law firm of Baron and Budd as soon as possible if you or a loved one has undergone additional surgeries to remove your transvaginal mesh implant. Give us a call at 866-472-9108 or visit our website at http://baronandbudd.com/areas-of-practice/pharmaceuticals/transvaginal-mesh-litigation/ to learn more.


The attorneys at Baron and Budd have been Protecting What’s Right for consumers for more than 35 years. Over the years, our national law firm has built a successful track record representing people who have been harmed by corporate wrongdoing. The firm’s pharmaceutical lawyers recently represented over 7,000 patients harmed by using the drug Avandia. Previously, Baron & Budd played a prominent role in litigation related to the diet drug Fen-Phen. As a result, the case settled for an amount valued at more than $1.275 billion (In Re Diet Drugs (Phentermine | Fenfluramine | Dexfenfluramine) Products Liability Litigation, MDL No. 1203 (E.D. Pa.).

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Amanda Billo
Baron & Budd
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