At some point in a woman’s life, the internal structures that support organs such as the bladder, bowel and uterus may stretch or weaken, resulting in conditions such as pelvic organ prolapse (POP) or stress urinary incontinence (SUI). POP occurs when the organs drop from their normal position and bulge or prolapse into the vagina. SUI occurs when urine leaks due to some sort of physical activity, such as normal exercise. Transvaginal mesh is a medical implant used to treat symptoms of POP and SUI and it was first introduced into the market in the late 1990’s..
The U.S. Food & Drug Administration (FDA) reported the following complications from transvaginal mesh: erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The severe adverse reactions to the transvaginal mesh may lead to permanent injury, pain and in some instances death.
Safety alerts regarding transvaginal mesh complications were first announced by the FDA in 2008—after more than 1,000 people complained of problems resulting from the mesh by at least nine different manufacturers. Alarmingly, by 2011 almost 3,000 new cases were reported. July 13, 2011 the FDA updated their 2008 alert to specifically state the transvaginal mesh complications are “not rare.”
The manufacturers of transvaginal mesh products include:
- American Medical Systems (AMS)
- Boston Scientific
- C.R. Bard, Inc.
- Johnson & Johnson