FDA Warns AMS, Manufacturer of Transvaginal Mesh
After the FDA inspected American Medical System’s manufacturing plant in Minnetoka, Minnesota in February, the transvaginal mesh manufacturer was placed under heavier scrutiny. According to the report that resulted from that inspection and which Endo Health Solutions, Inc. released in a filing with the U.S. Securities and Exchange Comission (SEC), the FDA issued three observations and met with the company to address how these issues could be corrected.
The company will be subject to a follow-up or otherwise the FDA may implement fines or refuse to grant future premarket approvals. As of today, AMS has already been hit with more than 17,000 lawsuits from injured clients who had AMS’ transvaginal mesh implanted in their bodies. The devices, which are designed to treat pelvic organ prolapse and stress urinary continence, have caused painful and serious complications for many of the thousands of women who have had them implanted, including organ damage and pain. The FDA’s observations against AMS only serve to underscore the fact that AMS has not provided the most stringent measures in the manufacturing of their devices, which in turn have severely impacted the quality of life of thousands of women.
The complications caused by this device have left many women to suffer with horrid recoveries, large medical bills, lost wages, and ongoing pain. From a civil standpoint, our firm has represented numerous families who are the victims of the complications from the transvaginal mesh device. If you or a loved one has experienced any of these problems because of an implanted or removed AMS transvaginal mesh, we encourage you to consult with one of our transvaginal mesh attorneys as soon as possible. A successful civil claim pursued against the responsible party will help compensate the victims for the costly medical expenses, and hopefully for their pain, suffering, and lost wages for time missed from work. Further questions can be directed to the Fears | Nachawati Law Firm by emailing the lead TV Mesh lawyer, Majed Nachawati at firstname.lastname@example.org, or by calling our office at 1.866.705.7584.
About the Author
Majed Nachawati is a preeminent Pharmaceutical Products Liability Lawyer with a focus on representing transvaginal mesh victims and families harmed by dangerous implantations on a nationwide basis—especially the Transvaginal mesh device. Mr. Nachawati has resolved numerous cases through trials and settlements that have resulted in seven and eight figure confidential settlements. He is on the Grievance Committee for the State Bar of Texas. He is licensed to practice before the Supreme Court of Texas and Arkansas, and is in most federal courts in the nation and holds specific licenses in the Northern, Southern, and Eastern Districts of Texas. Mr. Nachawati is a member of the Board of Directors of the Texas Trial Lawyers Association, the Board of Directors for Public Justice, a Leaders’ Forum and PAC member of the American Association for Justice. Mr. Nachawati has been recognized as a Super Lawyer in Texas Monthly Magazine for the past four consecutive years for legal excellence, in connection with pharmaceutical injury cases. Mr. Nachawati is also a member of The Million Dollar Advocates Forum. Mr. Nachawati can be reached by email at email@example.com or by calling 1.866.705.7584.