Transvaginal Mesh History

Transvaginal mesh is a medical device implanted into women’s pelvic areas through the vagina to treat weakened pelvic muscles resulting from pelvic organ prolapse, known as POP, and stress urinary incontinence, known as SUI. The product as it is known today has its roots in the 1950s, when surgeons used a mesh-like product to repair hernias.

Prior to the use of mesh, doctors would recommend two types of treatments for POP, which is when pelvic organs drop out of place and fall into the vagina, and SUI, a condition where women leak urine when their bladder is under stress, as is the case when exercising, laughing, coughing or sneezing. The first option was to perform a series of pelvic floor exercises, often called Kegels, to strengthen the pelvic floor muscles. The other option was the insertion of a pessary, a removable support system inserted into the vagina to treat POP.

By the 1970s, surgeons began utilizing the hernia-style mesh to treat POP and SUI. In the early days of these corrective surgeries, doctors would size and shape the pieces of mesh to each patient’s needs before surgically implanting it through the abdomen to add extra support to the pelvic floor.

With the growing popularity of treating POP and SUI through abdominal implantation, medical device manufacturers began trying to design a mesh that could be inserted through the vagina. Research from the U.S. Food and Drug Administration shows that surgeons were interested in transvaginal implantation over abdominal surgery because it was deemed less invasive, quicker and easier on the patient. Boston Scientific is credited with making the first transvaginal mesh, which was called the ProtoGen Sling. The FDA approved the sling’s use to treat SUI in 1996 through a premarket program. Three years later, however, the product was recalled due to developing safety concerns.

The use of mesh, also known as slings or tape, was first used for SUI surgery in 1998. The use of this type of mesh became popular with the release of a product made by Johnson & Johnson’s Ethicon unit called Tension-Free Vaginal Tape. It wasn’t until 2002 that a surgical mesh was designed specifically for POP patients. Also made by Johnson & Johnson’s Ethicon unit, the product was called Gynemesh PS.

The next advancement in transvaginal mesh was during the late 1990s when medical manufacturers began producing surgical mesh kits, which came complete with the pre-formed mesh device, tools for implantation and instructions for doctors to follow through the surgery.

In 2008, the FDA released a public health report stating that complications occurring from the use of transvaginal mesh for both POP and SUI treatments are rare. With this announcement, popularity for the device grew even more. Research shows that in 2010, 75 percent of POP surgeries were completed transvaginally, as were 80 percent of SUI surgeries.

Following continued research and analysis, the FDA released a follow-up public health review in 2011, essentially redacting its previous report. The FDA stated that serious adverse effects of the mesh are not rare and that transvaginally placed mesh in POP cases doesn’t conclusively improve the outcomes of comparable non-mesh surgeries. Later in the year, the FDA met with the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee to discuss the safety and effectiveness of transvaginal mesh used in both POP and SUI surgeries. Based off the panel’s discussion, it was recommended to reclassify the use of transvaginal mesh for POP from a low- to moderate-risk device to a high-risk device. Transvaginal mesh used for SUI was recommended to remain in the low- to moderate-risk device range.

The FDA continues to track the outcomes, safety and effectiveness of both POP and SUI surgeries with transvaginal mesh.

If you or a loved one have been injured by transvaginal mesh, contact our team of lawyers to help assert your legal rights.