FDA’s Transvaginal Surgical Mesh Hearings To Begin Soon

When we first began writing about problems with transvaginal surgical mesh, it was difficult to find much about it on a Google or Bing search. We were one of the first law firms in the country to represent victims injured by surgical mesh and we continue to remain closely involved in this issue and litigating cases on behalf of our clients.

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will be holding hearings that will be open to the public on the use of surgical mesh in women. The meeting will be held on September 8 and 9, 2011, from 8 a.m. to 6 p.m. in Maryland.

At these hearings, the committee plans to discuss the use of transvaginal surgical mesh and ultimately will make recommendations as to whether it is safe or effective to use this for pelvic organ prolapse repairs in women. We will be attending the hearings.

The purpose of these hearings is to secure the opinions of experts on both the risks and benefits, if any, in the use of mesh for POP and related surgeries. We are all now aware of the many reported and well-documented adverse events that have been submitted to the FDA. Such conditions and problems as vaginal erosion, pelvic pain and other serious effects will undoubtedly be reviewed.

After having approved the use of this device on a fast track. the FDA is now taking a closer look at whether it now must rectify its original haste to allow mesh use for these surgeries and may well reclassify the device to what is called a Class III (premarket approval) which would require more scrutiny, improving the labeling to ensure there is sufficient information and warnings about the use of mesh for female surgeries involving POP and other conditions, such as stress urinary incontinence, as well as closer study of adverse events and reporting.

We will report on the hearings and the resulting action, if any, by the FDA.

Hersh & Hersh has been at the forefront of litigation involving women’s health for four decades. We have been involved in landmark and historic litigation involving medical procedures, defective devices and dangerous drugs involving women. If you have been injured by a procedure involving surgical mesh for POP or incontinence, please contact our law firm. We will consult with you free of charge to evaluate your situation.

Please do not suffer in silence. Contact our law firm to speak with a lawyer who will consult with you in complete confidentially. Even if your doctor recommended that you have the surgery with the use of transvaginal mesh, you may well be entitled to damages for any injuries or pain you are now experiencing as a result.