Transvaginal Mesh Lawsuit
Transvaginal mesh entered the U.S. market in 1996 under the FDA’s 510(k) fast-track program. Mesh was initially used for hernia repair before being marketed to gynecologists and urologists as an alternative to native tissue repair of pelvic organ prolapse and stress urinary incontinence. As a consequence of fast-tracking, the safety and efficacy of vaginal mesh kits was not established in clinical trials.
The first-approved transvaginal mesh was manufactured as Protegen by Boston Scientific. This product was pulled after three years of being listed as a Class II medical device. Similar products have been voluntarily discontinued, but the FDA and other government regulators have taken a largely hands-off approach to the problem.
Transvaginal Mesh Side Effects
In 2008, the FDA issued a public health notification concerning the serious complications associated with transvaginal mesh. The FDA reported over 1,000 reports in three years of complications, including:
- Chronic pain
- Perforation of the bladder, blood vessels and bowels during the Insertion procedure
- Erosion through the vaginal epithelium
- Urinary problems
- Recurrence of incontinence or prolapse
- Pain during sex and resulting loss of libido
- Vaginal scarring
Serious complications lead to decreased quality of life, and the reported complications revealed implantation of transvaginal mesh was an ineffective procedure in some cases. Despite the number of reports and the unknown number of procedures, the FDA referred to these serious complications as “rare.”
As the number of transvaginal mesh lawsuits against mesh manufacturers grew, so did the pressure for the FDA to do something. Surgical procedures became more common as more women came forward to report complications. These procedures included drainage of abscesses and hematoma, IV therapy, blood transfusions, and mesh removal.
The FDA issued an update to the previous notification in July of 2011. In it, the FDA reversed the previous finding of rare complications by stating that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” This followed a review of the literature, which found increased risks associated with transvaginal mesh, no evidence of added benefits in comparison with non-mesh techniques and the newly identified complication of mesh contraction. Even with this knowledge, the FDA did not initiate a transvaginal mesh recall.