INFORMATION AND WHAT TO DO
The first transvaginal mesh product was introduced by Boston Scientific Corporation in the mid-1990s before the manufacturer voluntary recalled the product in 1999. Transvaginal mesh products were intended to be the faster and easier alternative to procedures aimed at correcting pelvic organ prolapse and incontinence. Pelvic organ prolapse and incontinence occur when the pelvic muscles weaken – usually following childbirth, a hysterectomy, or menopause – causing the pelvic organs (including the bladder, rectum, and uterus) to collapse into the vagina.
In an effort to correct pelvic organ prolapse and incontinence, synthetic transvaginal mesh is surgically implanted into the vagina and acts as a sling that upholds the pelvic organs. Transvaginal mesh is the same mesh that has been used successfully for years in surgical hernia repairs. However, prior to being released into the healthcare market, the mesh was never tested for safety in vaginal repairs. Rather, transvaginal mesh products were approved through the FDA’s controversial 510(k) system, which is the fast-track approval system of products that are similar enough to products already FDA-approved.
In 2008, the FDA released a public health announcement notifying consumers of injuries caused by transvaginal mesh products – but the injuries were considered rare. However, after reviewing scientific research, the FDA updated its advisory in 2011 to reflect its findings that transvaginal mesh injuries were not rare. Of the over 300,000 transvaginal mesh operations in 2010 alone, over 10% failed. Based on scientific research gathered between 1996 and 2011, the FDA determined that there is no conclusive evidence that transvaginal mesh repairs improve the quality of life more so than non-mesh repairs; that trans vaginal mesh operations involve more risks than non-mesh repairs; and that transvaginal mesh repairs to correct prolapse may not cure symptoms of prolapse.
Once implanted, the transvaginal mesh infuses with surrounding tissues and organs, thus making the process of removing the mesh difficult and sometimes impossible. In a study conducted by the Society of Genealogical Surgeons, 87% of women who had received a transvaginal mesh operation said they would not have had the operation if they had known prior to surgery what they now know about transvaginal mesh. Surgical removal of the mesh, which involves a lengthy recovery, is costly and dangerous. Because this type of removal surgery is a relatively recent procedure, there are not many experts in the field. Therefore, removing all the mesh pieces could involve several surgeries – and as many as seven removal surgeries for one patient have been documented.
Transvaginal mesh erosion occurs when the rough edges of synthetic mesh cut the vaginal lining and nearby organs. This and other complications associated with transvaginal mesh also cause: