Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Thousands of women have reported serious transvaginal mesh side effects such as: erosion of the mesh through the vaginal wall, infection and bleeding, vaginal shortening and tightening, bowel, bladder, and blood vessel perforation, pain and discomfort during sex (dyspareunia), and painful urination.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. The U.S. Food and Drug Administration has issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
Legal Commentary
From a civil standpoint, our firm has represented numerous individuals and families who have become victim to a transvaginal mesh’s dangerous side effects and the following psychological trauma. If you or a loved one has experienced any of these side effects you should contact one of our attorneys as soon as possible. A successful civil claim pursued against the responsible party will ensure the victims are not burdened with costly medical expenses, and will hopefully compensate them 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 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 Risperdal victims and families harmed by dangerous treatments on a nationwide basis. Mr. Nachawati has resolved numerous cases through trial and settlement 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.