On April 10, 2014, the FDA sent a warning letter to American Medical Systems, one of the largest transvaginal mesh manufacturers in the country. The warning letter came after the FDA inspected the company’s plant and found several issues that were related to risk analysis and other quality control problems. Although AMS has since responded and claimed that it would be implanting a corrective action plan with the help of the FDA.
The response by AMS also comes after hundreds of women have filed lawsuits against the company due to faulty transvaginal mesh devices that have caused physical and psychological issues. Transvaginal mesh devices are used to treat pelvic organ prolapsed and other problems. However, these devices have been known to erode and scar, causing pain and infection for patients. Many have to have surgery to remove the mesh after it causes problems. According to one study by the FDA, about 10% of women suffered mesh exposure within the first year of having the mesh implanted. The FDA in response has proposed that TV Mesh products be considered “high risk.” Furthermore, Endo Health Solutions, which owns AMS, has already paid more than $50 million in settlement claims.
The FDA has also recently required that post-market surveillance studies be undertaken by all transvaginal mesh manufacturers. AMS, in response, has begun enrolling patients in an Embrace study for two of its mesh products. 1,000 patients are expected to be included in the two studies, which are expected to take two years of enrollment and three years of follow-up for a full five years of data. The studies are expected to shed light on how the company can improve their mesh products.
Legal Commentary
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 mn@fnlawfirm.com, 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 mn@fnlawfirm.com or by calling 1.866.705.7584.