Source: US Food and Drug Administration (FDA)
The FDA has issued an update warning doctors and patients of the dangers of transvaginal mesh placement. This follows years of dramatic increases in reports of adverse events over the use of surgical mesh for the transvaginal repair of POP (pelvic organ prolapse). POP occurs when the internal structures that support the pelvic organs -the bladder, uterus, and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. Women with POP often experience pelvic discomfort; disruption of their sexual, urinary, and bowel functions; and an overall reduction in their quality of life.
The FDA previously suggested (in a 2008 report) that serious complications associated with surgical mesh for POP procedures and stress urinary incontinence were “rare.” In July of 2011, the FDA reversed their position on this issue stating that there was no clear evidence that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and actually may expose patients to “greater risk.” It appears the FDA is maintaining their latest position.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” according to William Maisel, MD, MPH, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
An FDA review of adverse events of all urogynecologic surgical mesh products from January 2005 to December 2010 identified 3979 reports of injury, death, and malfunction. There were 5x as many reports of adverse events associated with transvaginal mesh from January 1, 2008, to December 31, 2010 than in the previous 3 years, according to the FDA.
Erosion of mesh through the vagina and mesh contraction may lead to severe pelvic pain, painful sexual intercourse, or an inability to engage in sexual intercourse. infection and urinary and fecal incontinence. The FDA cleared the first surgical mesh product specifically for use in POP in 2002. Mesh manufacturers include: American Medical Systems; Bard; Boston Scientific; Johnson & Johnson and Caldera.
If you or a loved one underwent vaginal mesh implantation and are experiencing complications, contact the Lewis Law Firm to determine if you have a case against the manufacturer or the doctor who performed the procedure. Our free consultation and initial opinion may assist you.
Posted by: Gayle R. Lewis, Esquire