Introduced in the 1990s, transvaginal mesh was intended to permanently fix pelvic organ prolapse (POP) and stress urinary incontinence — conditions that typically plague older women after a hysterectomy or menopause. Pelvic prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs — including the bladder, rectum and uterus — drop into the vagina. SUI occurs when everyday activities place pressure on the bladder. To fix these conditions, a hammock-like piece of synthetic mesh is surgically implanted transvaginally, or through the vagina, to support the pelvic organs.

However, transvaginal mesh has several well-known complications such as organ perforation and erosion. Some of the less severe problems include constipation and urinary incontinence.

In 2008, the FDA issued a public health notification revealing the serious complications of transvaginal mesh, but said the occurrences were rare. Three years later, in 2011, the FDA updated its advisory to say that serious complications from vaginal mesh repair were not rare, and later ordered mesh manufacturers to conduct post-market safety studies.

Adding to the problem is the fact that this mesh — which has been successfully used to repair hernias for years — was never tested for vaginal repairs. The FDA’s fast-track approval system, called the 510(k), doesn’t require testing prior to market release as long as the product is similar to an already-approved product.

• Multiple Revision Surgeries Often Required to Correct Problems
• FDA Reviews Vaginal Mesh Safety but Declines to Recall¹⁾

• Transvaginal Mesh
• FDA: Serious Complications Associated with TVM for POP