An Indian health news web site reports that hundreds of women in Scotland have filed lawsuits over complications from transvaginal mesh implants, joining women worldwide in litigation over serious and permanent injuries from the devices.
Transvaginal mesh devices – made from synthetic or biologic materials – are implanted to treat such conditions as pelvic organ prolapse (POP) and stress urinary incontinence (SUI), by strengthening pelvic walls and supporting organs, according to HealthIndia.com. But health regulators worldwide have received reports of numerous complications linked to transvaginal mesh, including
• mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
• organ perforation
• urinary problems
For some women, complications occur during the device insertion itself; women suffer bladder, bowel, or blood vessel perforations, according to Health.India.com. Some women need additional surgery to remove the mesh or repair injuries, but, according to a 2011 Safety Communication from the U.S. Food and Drug Administration (FDA), additional surgery does not always resolve the problems.
In the U.S., hundreds of lawsuits have been filed against transvaginal mesh implant makers including Boston Scientific, C.R. Bard, Endo, and Johnson & Johnson’s Ethicon division. In 2012 the FDA ordered more than 30 manufacturers to undertake a three-year safety study of organ damage and complications linked to transvaginal mesh implants. Health regulators and attorneys expect continued litigation in light of growing evidence of serious safety issues.
The FDA has warned women and their doctors that complications linked to transvaginal mesh implants are “not rare.” The agency says it is not clear that transvaginal POP repair with mesh is more effective than non-mesh repair and it may expose patients to greater risk.