Transvaginal mesh is a net-like contraption implanted surgically through the vagina to help support damaged vaginal tissue. Considered easier to insert than abdominal meshes that have been used since the 1950’s to treat hernias, transvaginal mesh became FDA-approved in 1996 to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These conditions tend to plague women post-childbirth, after a hysterectomy, or during menopause.
But within a month after surgery, women who receive transvaginal mesh implants often experience chronic pain and more severe conditions, like the erosion of the vagina and organ perforation. By 2016, after years of intense study of the transvaginal netting design and implantation technique, the FDA publically rendered this surgical mesh to be a high-risk device, warning that complications after surgery “are not rare” and that these surgeries are no more effective than non-mesh treatments for prolapse.
Uses of Transvaginal Mesh
Over half of women in the US experience prolapse at some point in their lifetime, but only a few of these women need surgery for prolapse treatment. Most common after some sort of trauma on the body, like a hysterectomy, prolapse is essentially a weakened vagina wall that’s collapsed after the uterus has been removed, or the vaginal tissues have been weakened from a major event, like giving birth or experiencing menopause.
Pelvic Organ Prolapse (POP):
Pelvic organ prolapse happens when surrounding pelvic organs drop into the vaginal canal due to weakened pelvic muscles. Typically occurring in older females, POP can affect the uterus, rectum, and bladder. Sometimes the uterus collapses into the vaginal canal, while in rectocele, the rectum bursts from the lower vagina wall. Anterior prolapse, meanwhile, happens when the bladder drops from the upper wall of the vagina (cystocele).
In 2002, the FDA approved a mesh design that works like a hammock to hold up the collapsed organs or weakened tissues in the vagina wall. This POP-specific mesh can be inserted abdominally or transvaginally.
Stress Urinary Incontinence (SUI):
Stress incontinence is a condition experienced by 24-percent of women. During bursts of physical activity, like jumping or running, or episodes of coughing or sneezing, SUI is caused by increased pressure on the bladder resulting in leaked urine.
The FDA approved an SUI mesh, referred to as a ‘bladder sling,’ in 1996. This mesh specifically supports the urethra. Eighty-percent of SUI mesh surgeries is done transvaginally.
A Brief History of Transvaginal Mesh
Inspired by transabdominal meshes used in hernia repair surgeries in the 1950’s, transvaginal mesh products were initially crafted by surgeons doing these procedures. During those days, doctors would take a piece of mesh and cut it to the specific shape and size of each patient. The mesh would then be implanted abdominally to treat POP and SUI.
By the 1970’s, manufacturers had taken note of the practice and began pre-packaging POP- and SUI-specific mesh products to sell in kits. Kits included tools and instructions for implantation, the ease, and accessibility of which led to increased problems of transvaginal mesh in patients.
It wasn’t until 1996 when the FDA officially approved the first transvaginal mesh device. Most products were approved based on the performance of one product, the ProtoGen Sling. But by 1999, the ProtoGen Sling was recalled over safety concerns discovered by the FDA.
Despite a Public Health Safety Notification released in 2008 warning of potential risks, 300,000 transvaginal mesh surgeries were performed in the US in 2010. With these surgeries came an increase in complaints of complications due to the devices. In 2011, the FDA updated their public warnings to say that transvaginal mesh surgery was not only risky but was also not as effective as non-mesh repairs.
The FDA updated their website in 2016 to reveal that transvaginal mesh products used to treat POP were no longer a moderate-risk device (class II) but a high-risk device (class III) that would now “require manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness.”