A woman was awarded $1.2 million after a Texas jury found Johnson & Johnson liable for design defects in one of its transvaginal mesh devices that caused the plaintiff to suffer pelvic injuries. Linda Batiste, 64, claimed she suffered complications when her TVT-O bladder sling eroded inside her body. It was the first verdict against Johnson & Johnson involving its TVT-O device.
Transvaginal mesh is a type of surgical mesh used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have prolapsed, or dropped, resulting in discomfort, pain and urinary incontinence.
In 2011, the Food and Drug Administration (FDA) warned that complications with the devices were not uncommon and that women considering transvaginal mesh should weigh the risks against the benefits. Complications included erosion, protrusion, and perforation of organs resulting in symptoms such as hemorrhaging, chronic pain, infections and, in some cases, death. Some women had to undergo repeated surgeries to remove the mesh; many suffered lifelong consequences.
The FDA has since ordered Johnson & Johnson and 32 other manufacturers of transvaginal mesh to collect data on organ damage and other complications caused by the implants.
Johnson & Johnson and its unit Ethicon face more than 12,000 lawsuits involving defectively designed bladder slings. Last year, the companies were ordered to pay $11.1 million in damages to a woman who claimed the company’s Prolift transvaginal mesh device caused her injury. Johnson & Johnson has since discontinued some of its lines of transvaginal mesh implants but continues to market the TVT-O sling.