Transvaginal mesh is a surgical net-like implant, manufactured by various companies such as Ethicon, C.R. Bard, American Medical Systems, Boston Scientific, Coloplast, Cook Medical, Neomedic. It is used in the form of a sling to treat stress urinary incontinence (SUI) and Pelvic organ prolapse (POP) in women since the 1990s. The insertion of this mesh or a bladder sling through the vagina is known as a transvaginal mesh. The Food and Drug Administration (FDA) approved the first surgical mesh specifically designed for SUI in 1996. Later, in 2004, the FDA approved the first surgical mesh specifically for use in POP.
Manufacturers typically make these meshes from a plastic named polypropylene, though some meshes may use animal tissue. Doctors use this type of surgical mesh to permanently fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Doctors began using the mesh abdominally to repair POP in the 1970s. By the 1990s, gynecologists were using mesh for surgical treatment of SUI and transvaginal repair of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Analysis of the market data by the manufacturers points out that as of 2010, a mesh was used in one out of three POP surgeries. Moreover, a transvaginal mesh was used in over 80% of the SUI surgeries. According to the FDA, surgeons performed approximately 260,000 mesh surgeries for urinary incontinence in 2010. Surgeons in the United States performed about 300,000 surgeries for POP in 2010. At the height of synthetic mesh use in 2006, one-third of all POP surgeries using mesh.
FDA began issuing warnings for complications in 2008 and 2011. The FDA focused its regulatory efforts on transvaginal mesh for POP, a procedure that the agency finds riskier. In 2016, it classified mesh for POP as a high-risk, Class III device. Then in April 2019, the Food and Drug Administration (FDA) ordered manufacturers to stop selling all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse. The agency said it did not find adequate evidence to assure that the probable benefits of these devices outweighed the probable risks.
Using Transvaginal Mesh for Incontinence or Prolapse
Medical practitioners use transvaginal mesh for symptomatic pelvic organ prolapse or stress urinary incontinence. Symptomatic refers to patients experiencing pain, discomfort, or other unpleasant symptoms.
Some patients are asymptomatic, and they may not require treatment, or conservative treatments may provide relief. Surgery may be recommended by doctors when certain standard choices like pelvic floor rehabilitation, observation, pessaries fail to show expected results.
Pelvic Organ Prolapse (POP)
Pelvic organ prolapse (POP) occurs when organs sag or fall into the vaginal canal because of weak pelvic muscles. The transvaginal mesh works like a hammock beneath the organs to hold them up. Mostly, the bladder, uterus, rectum, or bowel is involved in the prolapse. The bladder is the most commonly affected organ.
Depending on the organs involved, doctors may place the section of mesh on the front, back, or top wall of the vagina. The type of mesh used also differs in shape and size. This type of surgery is usually performed transvaginally.
Stress Urinary Incontinence (SUI)
Stress urinary incontinence (SUI) takes place when the bladder leaks urine during moments of more physical activity that increase pressure on the bladder. The mesh supports the urethra when pelvic muscles weaken.
Surgical treatment of SUI with mesh also called a bladder sling or vaginal tape is the most common type of surgery used to correct the state. Surgeons use the transvaginal placement of bladder slings because it is minimally invasive and the incisions are small.
The FDA differentiates mesh into four types for gynecological use based on how the mesh reacts inside of the body. The four types include:
Non-Absorbable synthetic: Non-Absorbable synthetic meshes are made from synthetic materials, such as plastic or polyester. Most mesh devices are made of polypropylene.
Absorbable synthetic: The body absorbs absorbable synthetic mesh, and tissue grows at the implant site. This helps strengthen the ligaments in the pelvis.
Biologic: Biologic meshes are natural products derived from animal tissue that has been disinfected. These products demean over time and are usually made from cow (bovine) or pig (porcine) tissue.
Composite: Composite mesh is made from a combination of non-absorbable synthetic, absorbable synthetic, or biologic mesh.