A transvaginal mesh implant is a synthetic, net-like medical device designed to support weakened pelvic tissues. Placed through the vagina, it aimed to reinforce pelvic muscle walls and alleviate symptoms of various pelvic floor disorders.
Conditions Addressed by Mesh
Transvaginal mesh was used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). POP occurs when pelvic organs, such as the bladder, uterus, or rectum, descend from their normal positions due to weakened muscles and ligaments. The mesh was intended to support these organs.
Stress Urinary Incontinence involves involuntary urine leakage during physical activities like coughing, sneezing, or exercising. For SUI, transvaginal mesh, often referred to as a midurethral sling, was designed to support the urethra or bladder neck, preventing urine leakage. While mesh offered improved outcomes for POP repair compared to native tissue repair, its effectiveness for SUI repair was similar to traditional methods.
Reported Complications
Despite its initial promise, transvaginal mesh implants have been associated with serious adverse events. Mesh erosion is a frequently reported complication, where the synthetic material breaks down or protrudes through the vaginal wall. This erosion can lead to discomfort, bleeding, and infection. In severe cases, the mesh can erode into surrounding organs like the bladder, urethra, or rectum, causing organ perforation.
Chronic pain is another widespread issue, often manifesting as pelvic, groin, or leg pain, and can be debilitating. Pain during sexual intercourse (dyspareunia) is also a common and distressing complication. Infections in the pelvic region are a risk, potentially leading to fever, redness, and swelling, often requiring antibiotics or further surgery.
Urinary problems can include difficulty urinating, increased frequency or urgency, or the inability to fully empty the bladder. In some instances, the mesh may shrink or contract over time, causing tension and a pulling sensation in the pelvic area, contributing to pain and discomfort. These complications can affect quality of life and may necessitate multiple surgeries.
Regulatory Actions and Current Status
The U.S. Food and Drug Administration (FDA) has taken escalating actions regarding transvaginal mesh implants due to increased adverse event reports. In October 2008, the FDA issued a public health notification about transvaginal mesh safety, citing over 1,000 complication reports. An updated safety communication followed in July 2011, which emphasized higher than expected adverse effects.
In 2016, the FDA reclassified surgical mesh for transvaginal POP repair from Class II (moderate risk) to Class III (high risk), requiring extensive clinical studies to demonstrate safety and effectiveness. In April 2019, the FDA banned the sale and distribution of transvaginal mesh for POP repair, concluding that manufacturers had not demonstrated a reasonable assurance of its safety or effectiveness.
Despite these restrictions, transvaginal mesh for Stress Urinary Incontinence (SUI) remains available. Midurethral slings for SUI, often made of synthetic mesh, are still considered a standard surgical treatment option. This distinction is due to significantly lower mesh-related complication rates after SUI repair compared to POP repair.
Alternative Treatments and Management Options
For individuals seeking treatment for pelvic organ prolapse or stress urinary incontinence without mesh, alternatives exist. Non-surgical approaches include pelvic floor physical therapy, which helps strengthen pelvic muscles through exercises like Kegels. Vaginal pessaries, removable devices inserted into the vagina, can provide support to pelvic organs and alleviate symptoms. Lifestyle modifications, such as weight loss and avoiding heavy lifting, also help manage symptoms.
Surgical options that do not involve mesh include native tissue repair, using a person’s own tissues to reinforce weakened structures. For POP, procedures like colporrhaphy repair and reinforce vaginal walls. For SUI, non-mesh surgical alternatives include Burch colposuspension and fascial pubovaginal slings, using a person’s own tissue to support the bladder.
For those with a transvaginal mesh implant experiencing complications, management options vary. Conservative approaches may include pain medication, topical estrogen cream, or antibiotics for infections. Surgical intervention, such as partial or complete mesh removal, is often necessary to alleviate symptoms. Mesh removal can be a complex procedure due to scar tissue, and complete symptom resolution, particularly pain, is not always guaranteed.