Transvaginal mesh is usually made of plastic called polypropylene. Some types of transvaginal mesh use a combination of materials, including animal tissue. The term “transvaginal” refers to the type of surgical technique used to implant the mesh.
This type of surgical mesh was created to permanently fix pelvic organ prolapse and stress urinary incontinence. These conditions may affect women after a hysterectomy, menopause or childbirth.
In these procedures, doctors surgically place the mesh through the vagina or the abdomen. Inserting the mesh through the vagina is quicker, easier and less invasive.
Transvaginal mesh was created to help women suffering from SUI and POP, but many of the devices caused serious complications. The design and manufacturer-recommended implantation technique of some of these transvaginal mesh products contributed to problems such as infection, erosion of the vaginal tissues and organ perforation.
Reports of complications came too late for hundreds of thousands of women who already had mesh implanted, but most companies never recalled the devices. More than 100,000 women sought compensation for their mesh injuries by filing lawsuits against the manufactures. Those cases resulted in multimillion dollar verdicts and more than $1 billion in settlements.
The U.S. Food and Drug Administration recognized that complications involving transvaginal mesh are not rare. The agency reclassified the devices as “high risk.” Some surgeons have stopped using transvaginal mesh because of high rates of complications, but others continue to use mesh to treat SUI and POP.
History of Transvaginal Mesh
Transvaginal mesh products evolved from surgical mesh that was originally used during hernia repair in the 1950s. Surgeons began using the mesh abdominally to repair POP and SUI in the 1970s. The doctors took a piece of surgical mesh and cut the desired shape and size for use in each patient, then surgically implanted it.
Medical device manufacturers noticed the clinical practice and responded by creating mesh products specifically designed to treat POP and SUI. As the usage of these products expanded, manufacturers began selling their mesh products in kits. The kits were prepackaged with mesh, special tools and instructions to help doctors implant it.
Some doctors, including urogynecologist Dr. Christopher Walker, believe that the introduction of these kits contributed to some of the problems with transvaginal mesh.
“The mesh kits had such a high volume, I think, because there were so many put in, That’s now causing us to see a high incidence of mesh complications.”- Dr. Christopher Walker, Urogynocologist
Numerous reports of adverse effects surrounding transvaginal mesh prompted the FDA to conclude that complications from the devices were not rare, and the devices were not more effective than alternative treatments. Survey results showed that surgeons who specialize in urogynecology were less likely to use transvaginal mesh after the safety notices.
The FDA did not require transvaginal mesh manufacturers to conduct studies on the products in humans before clearing them through a fast-track approval program. Many of the products on the market today were approved based on the ProteGen Sling, which was recalled in 1999. The FDA concluded that the ProteGen had a “higher than expected rate of vaginal erosion” and did “not appear to function as intended.”
A Brief History of Transvaginal Mesh and the FDA
First transvaginal mesh device approved for SUI
ProteGen Sling recalled because of safety concerns
First transvaginal mesh product for POP approved
First public health safety notification about mesh
Public health safety notification updated and strengthened
FDA panel on mesh held
Mesh makers ordered to conduct post-market studies
Proposal to reclassify mesh devices issued
Transvaginal mesh for POP reclassified as high-risk
By December 2017, transvaginal mesh was coming under increasing global regulatory scrutiny.
In November 2017, The BBC reported that the UK’s National Institute for Health and Care Excellence (NICE) would likely recommend in December that the country’s National Health Service (NHS) ban the use of transvaginal mesh. The NHS is not compelled to follow NICE’s recommendations. But a flurry of reports in UK media of injuries relating to the devices raised attention to complications women were suffering.
Also in November 2017, Australia’s Therapeutic Goods Administration (TGA) banned surgical mesh for treatment of POP and SUI. New Zealand’s regulatory agency, Medsafe, followed suit with a similar ban taking effect on January 4, 2018.
Types of Transvaginal Mesh
Different types of transvaginal mesh are used to treat POP and SUI. Transvaginal mesh that treats POP is sometimes referred to as synthetic mesh, a graft, a patch, biomesh or a vaginal support system. Mesh that’s used during SUI surgery is commonly referred to as a bladder sling. There are four categories of transvaginal mesh. They’re categorized by types of material and how they react inside of the body.
Categories of Transvaginal Mesh
There are four categories of transvaginal mesh. They’re categorized by types of material and how they react inside of the body.
The four categories include:
- Non-Absorbable synthetic – A permanent implant that remains in the body indefinitely. More than half of all mesh products approved by the FDA fall into this category. They are made from synthetic materials, such as plastic or polyester. About 90 percent of non-absorbable synthetic mesh is made of polypropylene.
- Absorbable synthetic – Mesh that loses strength and degrades over time. It isn’t designed to be a long-term treatment. As the mesh is absorbed by the body, tissue grows at the implant site, which helps strengthen the ligaments in the pelvis.
- Biologic – Natural products derived from animal tissue that has been disinfected. These products degrade over time and are usually made from cow (bovine) or pig (porcine) tissue.
- Composite – Mesh made from a combination of non-absorbable synthetic, absorbable synthetic or biologic mesh.
Surgeons who use transvaginal mesh usually prefer non-absorbable synthetic mesh because it reacts better with connective tissue, increasing repair strength. Non-absorbable implants also have a lower rate of infection than absorbable implants. However, all implants have a risk of erosion and other complications.
Transvaginal Mesh Brands & Products
Mesh manufacturers made more than 100 transvaginal mesh products. Most manufacturers tried to develop ways to differentiate their products from competitors, but the brands and kits share common characteristics. Their incision mechanisms, components that attach to the body and other materials may slightly differ.