FDA To Discuss TVM Complications in February Next Year

FDA To Discuss TVM Complications in February Next Year

Introduction

As per a notice posted at the Federal Registry, members of the U.S. Food & Drug Administration's (FDA)  Obstetrics and Gynecology Devices Advisory Committee will soon convene a meeting on February 12, 2019, to discuss transvaginal mesh implant complications in Pelvic Organ Prolapse Repair.

The notice stated, “FDA is convening this meeting to seek expert opinion on the evaluation of the risks and benefits of these devices. The Committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit/risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices.” Public comments on this issue will be accepted by the FDA until January 27.

The meeting has been scheduled to identify concerns about the complications of the devices and revise the regulatory guidelines to protect patients from harmful situations. In the past, defective surgical mesh products were pulled off the market after a huge number of complaints reported adverse events like recurrent prolapse, neuromuscular problems, vaginal scarring/ shrinkage, urinary problems. More than 100,000 women have been affected by transvaginal mesh defects. Lawsuits linked to TVM complications are filed in several state courts against American Medical, Systems, Inc., Boston Scientific Corp., C.R. Bard, Ethicon, Inc., and other defendants have either settled or are in the process of settling many of these claims.