Vaginal mesh is a surgical implant used in gynecological procedures to provide structural support for weakened tissues. This implant is designed for permanent placement within the body.
What is Vaginal Mesh
Vaginal mesh is a medical device, primarily composed of synthetic materials like polypropylene. These synthetic meshes can be found in knitted or non-knitted sheet forms. Some meshes are also derived from biological materials, such as animal tissue, processed for implantation.
The mesh is implanted during surgery, often transvaginally, through an incision in the vaginal wall. Its design includes holes to allow the body’s own tissues to grow into the mesh. While some meshes are absorbable and degrade over time, most surgical meshes used for gynecological repairs are non-absorbable.
Conditions It Treats
Vaginal mesh has been used to address two main conditions: Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). SUI involves the involuntary leakage of urine during physical activities that put pressure on the bladder, such as coughing, sneezing, or lifting. For SUI, a thin strip of mesh is placed to support the urethra or bladder neck, acting like a hammock to prevent urine leakage.
Pelvic Organ Prolapse occurs when the pelvic floor muscles and tissues weaken, causing organs like the bladder, uterus, or rectum to descend and bulge into or out of the vagina. For POP, the mesh is implanted to reinforce the weakened vaginal wall and help hold the prolapsed organs in their correct position.
Associated Complications
Despite its intended purpose, vaginal mesh has been associated with a range of complications. One of the most frequently reported issues is mesh erosion or extrusion, where the mesh material pokes through the vaginal tissue, sometimes extending into nearby organs like the bladder or rectum. This can lead to symptoms such as pain, bleeding, and discharge.
Chronic pain is another common complaint, often manifesting as pelvic pain that can radiate to the lower back or thighs. This includes dyspareunia, or pain during sexual intercourse. Infections can also occur, as the mesh can become a site for bacterial growth, leading to fever, localized pain, and recurrent urinary tract infections.
Further complications include organ perforation, where the mesh accidentally punctures nearby organs like the bladder, bowel, or urethra during placement or as a long-term consequence. Mesh shrinkage or contraction over time can also cause tension and pulling sensations in the surrounding tissues, contributing to pain. Some individuals may also experience nerve damage, leading to neuropathic pain. Even after mesh surgery, there is a possibility of recurrence of SUI or POP symptoms.
Alternative Treatments
For managing Stress Urinary Incontinence (SUI), several non-mesh options are available. Pelvic floor muscle training, commonly known as Kegel exercises, is often a first-line non-surgical treatment aimed at strengthening the muscles that support the bladder. Behavioral therapies, such as bladder training to increase the time between urination, and lifestyle adjustments like fluid management and avoiding caffeine, can also help.
Surgical alternatives for SUI include traditional “sling” procedures that use the patient’s own tissue, known as autologous fascia. These pubovaginal slings elevate and support the bladder neck. Bulking agents can also be injected into the urethra to increase its resistance to urine leakage. Another surgical option is the Burch colposuspension, which involves stitching the vaginal wall to ligaments near the pubic bone to support the urethra.
When addressing Pelvic Organ Prolapse (POP) without mesh, non-surgical approaches include the use of pessaries, which are removable devices placed into the vagina to physically support the prolapsed organs. Lifestyle modifications, such as weight loss and avoiding heavy lifting, can also help alleviate symptoms. Surgical options for POP that do not involve mesh include native tissue repair, such as colporrhaphy, where the patient’s own tissues are used to repair and reinforce the vaginal walls. In some situations, a hysterectomy, the removal of the uterus, may be considered if it is contributing to the prolapse.
Regulatory Actions and Patient Recourse
The U.S. Food and Drug Administration (FDA) has taken significant actions in response to the reported complications associated with vaginal mesh. In 2016, the FDA reclassified surgical mesh products used for transvaginal repair of pelvic organ prolapse as Class III (high-risk) medical devices. This reclassification required manufacturers to submit new safety and effectiveness data.
Ultimately, in April 2019, the FDA ordered manufacturers of all remaining transvaginal mesh products for pelvic organ prolapse repair to stop selling and distributing them in the U.S., citing a lack of demonstrated reasonable assurance of safety and effectiveness. This decision followed years of increasing adverse event reports and a determination that these devices did not consistently offer benefits superior to surgery without mesh. The FDA continues to allow the use of synthetic mesh slings for stress urinary incontinence and for abdominal repair of pelvic organ prolapse, noting that these procedures have different risk profiles.
The widespread patient concerns and complications have led to a substantial number of legal claims against manufacturers of synthetic mesh products. These actions have resulted in significant financial settlements. This broader legal landscape underscores the systemic impact of mesh-related issues on public health.