Since the 1950s, surgical mesh has been used in the repair of abdominal hernias, and the practice was adopted by gynecologists in the 1970s to treat hernias and conduct abdominal repairs of prolapse.

The first transvaginal mesh product was cleared by the FDA in 1996. Manufactured by Boston Scientific, the product was called ProteGen vaginal cling and was intended only for stress urinary incontinence. In 1998, Johnson & Johnson received approval from the FDA for its product Gynecare TVT vaginal mesh sling. It gained approval based on its similarity to ProteGen but was not rigorously tested. The same was true of many subsequent products.

The very next year, in 1999, Boston Scientific recalled its product due to more than 100 reports of complications, although other manufacturers continued marketing and selling their surgical mesh products.

The FDA cleared surgical mesh as a treatment solution for pelvic organ prolapse in 2002, although by 2008 thousands more reports linking transvaginal mesh devices to complications, such as infections, vaginal scarring, pain, and bowel and bladder perforation, arose. At this point, the FDA issued its first warning.

The differing terminology between medications and devices is critical to the controversy surrounding transvaginal mesh products. The FDA has a 501(k) process that requires manufacturers to show that a device is “substantially equivalent” to a comparable device presently on the market, whereas drugs face much more intense scrutiny in order to gain approval from the FDA. In short, the FDA does not traditionally require safety or efficacy trials related to devices.

In 2010, there were more than 100,000 repairs carried out using surgical mesh to address pelvic organ prolapse in female patients, 75,000 of which involved transvaginal procedures. Another 260,000 surgeries were estimated for stress urinary incontinence, with more than 200,000 of the cases involving a surgical mesh device.

In 2011, the FDA issued a second warning, this time stressing the likelihood of complications and warning women of increased risks related to the use of a surgical mesh product. Around this time, the FDA was considering reclassifying transvaginal mesh devices as more high-risk than previously categorized, which would require clinical studies and more in-depth research into the safety and effectiveness of the products.

That same year, the husband of a transvaginal mesh patient filed a lawsuit against Boston Scientific and Ethicon, two manufacturers of mesh products received by his wife. The lawsuit claimed that the manufacturers concealed the debilitating and irreversible injuries incurred by their products, failing to warn patients of the risks.

In the U.S. District Court for the Southern District of West Virginia, there are currently nearly 40,000 lawsuits related to transvaginal mesh injuries pending, with many others pending in state courts.