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FDA Moves to Label Transvaginal Mesh From ‘Moderate Risk’ to ‘High Risk’ Category

The number of transvaginal mesh lawsuits has drastically increased in the past few months, as more and more women who have suffered as a result of the mesh have come forward. According to recent court documents, more than 50,000 transvaginal mesh lawsuits have been filed in the U.S. District Court, Southern District of West Virginia, by women who have been injured by a mesh product.

In light of the significant number of lawsuits related to various mesh products, the FDA has also moved to rate transvaginal mesh from a moderate risk device to a high-risk one. Devices labeled as moderate risk do not have to conduct human clinical trials before market. However, high-risk devices have higher levels of scrutiny imposed on them and manufacturers must submit pre-market approvals and undergo various evaluations.

Although the move by the FDA comes after a significant number of women have been harmed by the mesh, it will require manufacturers to provide more stringent testing before their mesh products are allowed in the market. So far, all of these new requirements by the FDA reveal that mesh manufacturers have been allowing faulty devices into the market for far too long.

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, 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 or by calling 1.866.705.7584.


Drug Litigation