Pharmaceutical

Woman files lawsuit against transvaginal mesh manufacturer

For years, Mary Ann McCloskey didn’t know what was wrong with her. It was as if her internal organs were revolting against her body. She endured pain, internal bleeding, and multiple surgeries. Her quality of life plummeted. It wasn’t until February 2010, that Mary Ann discovered her problem wasn’t a medical mystery, but was likely caused by the transvaginal mesh surgically implanted in her pelvis during a medical procedure she received in 2006. The surgical mesh had eroded into her vaginal wall, causing pain and severe complications.

Mary Ann is suing C.R. Bard, manufacturer of the Bard pelvi soft acellular collagen biomesh, claiming her injuries are a result of the mesh. Not only has she suffered physically, Mary Ann claims she lost her normal life, incurred medical costs and suffered an impairment to her earning capacity.

Mary Ann is just one of thousands of women who have reported experiencing problems after receiving transvaginal mesh. The mesh is used to repair pelvic floor disorders including pelvic organ prolapse (POP) and urinary incontinence. The Food and Drug Administration (FDA) has received more than 1,500 reports of problems associated with POP repair between 2008 and 2010 – five times as many as the agency received between 2005 and 2007.

An FDA advisory panel recently conducted a safety review of transvaginal mesh used for POP and urinary incontinence (where it is commonly referred to as a bladder sling).

Despite pressure from consumer groups to ban the mesh for such purposes, the panel ultimately decided that any other mesh products for POP or incontinence repair be tested before they are approved for use. The FDA is not required to follow the advice of its advisory panels, but it usually does. The agency has yet to offer a recommendation on transvaginal mesh.

Source: The Madison Record