Transvagin*l Mesh: Uses, Complications & Lawsuits (2024)

What Is Transvagin*l Mesh?

Transvagin*l mesh is a net-like medical device that repairs weakened or damaged tissue in a woman’s bladder or pelvic area. Surgeons use mesh to permanently fix pelvic organ prolapse and stress urinary incontinence.

The surgical mesh can reinforce and support the vagin*l wall, urethra or bladder neck. Manufacturers typically make them from a plastic called polypropylene or from animal tissue.

Is Transvagin*l Mesh Banned?

Transvagin*l mesh for POP repair is under an FDA ban, though its use in treating SUI in a sling procedure isn’t. Reports of complications led the FDA to find that the risks outweigh the benefits for treating prolapse.

While FDA required the POP mesh kit to withdraw from the market, to date there are no recalls on transvagin*l mesh devices. The FDA’s action did not apply to mid-urethral slings or in abdominal surgeries to support the vagin*l wall.

FDA Actions

April 2019: The FDA orders manufacturers of transvagin*l repair mesh for POP to immediately stop sales and distribution.
January 2012: The FDA ordered postmarket surveillance studies to address the safety and effectiveness of the use of surgical mesh in transvagin*l repair.
July 2011: The FDA issues safety communications regarding transvagin*l mesh.

In October 2022, the FDA issued a final report on the effectiveness and safety of Coloplast mesh devices, even though it was no longer on the market. The FDA believes these devices have risks of mesh exposure and erosion. In August 2021, similar findings from the final report of the outcome of the Boston Scientific Transvagin*l Mesh for POP supported the initial ban from the FDA.

vagin*l Mesh in Other Countries

Several countries issued bans and restrictions on transvagin*l mesh after growing reports of complications and public concern. Australia led the way, with the U.K., Canada, New Zealand and France following. The Netherlands imposed restrictions on use, while Germany, Austria and Switzerland allow for mesh in POP repair in certain circ*mstances.

Global Restrictions

July 2019: Canada restricts transvagin*l mesh.
June 2019: The U.K. updates the hold on transvagin*l mesh.
July 2018: England pauses all mesh operations.
December 2017: New Zealand bans transvagin*l mesh.
November 2017: Australia bans transvagin*l mesh for prolapse.

Are There Current Transvagin*l Mesh Uses?

The FDA ruling banned transvagin*l mesh for pelvic organ prolapse, which now relies on transabdominal surgical mesh. It can still be used to treat urinary incontinence, however.

Stress urinary incontinence occurs when the bladder leaks urine during moments of intense physical activity with increased bladder pressure. Transvagin*l mesh supports the urethra when pelvic muscles weaken.

A bladder sling is the most common type of mesh that doctors use to correct SUI. Thetransvagin*l placement is minimally invasive.

Transvagin*l Mesh Types

There are four categories of transvagin*l mesh that doctors use for gynecologic purposes. These categories indicate how the mesh reacts inside the body.

Absorbable Synthetic: The body absorbs this type of mesh into the tissue growing at the implant site. This strengthens the ligaments in the pelvis.
Biologic: These are natural products using animal tissue that degrades over time.
Composite: This mesh uses a combination of nonabsorbable synthetic, absorbable synthetic or biologic mesh.
Nonabsorbable synthetic: This mesh uses synthetic materials, such as plastic or polyester. Synthetic polypropylene is the most common mesh type for treating pelvic floor disorders.

Many surgeons prefer to work with nonabsorbable synthetic mesh because it reacts better with connective tissue and increases repair strength. There is also a lower rate of infection compared to absorbable implants.

Although many still refer to a gynecological treatment for POP repair as transvagin*l mesh, there are no kits on the market for this procedure. Surgeons must choose a free mesh and secure it with different anchoring techniques.

Manufacturers and Brands of Transvagin*l Mesh Implants

There are several manufacturers of mesh brands. Some brands include options for POP as well as SUI repair.

Transvagin*l Mesh Products

Boston Scientific: Pinnacle Pelvic Floor Repair Kit, Uphold vagin*l Support System, Advantage, Obtryx Slings
C.R. Bard: Avaulta Solo, Avaulta Plus, Align Urethral Support System, Pelvilace Support Systems, Uretex Urethral Support Systems
Coloplast: Minitape, Aris Transobturator Sling, Omnisure, Novasilk Sling
Endo/American Medical Systems: Perigee, InteXen, IntePro, MiniArc Slings, Bio Arc Slings, Monarc Slings
Johnson & Johnson/Ethicon: Gynecare Prosima Pelvic Floor Repair System, Gynecare Prolift Kit, Gynecare TVT Secur, Gynecare Prolift + M Kit
Mentor: ObTape

The FDA has not issued mandated recalls on transvagin*l mesh. Boston Scientific, however, issued a voluntary recall in 1999 on its ProteGen mesh.

Transvagin*l Mesh: Uses, Complications & Lawsuits (1)

Complications of Transvagin*l Mesh

Some patients have experienced major medical complications related to the use of transvagin*l mesh. The FDA reported that it had received 2,874 reports of injury, death, malfunctions and other transvagin*l mesh-related complications from Jan. 1, 2008 to Dec. 31, 2010.

Transvagin*l Mesh Complications

Bleeding
Infection
Mesh erosion
Nerve damage
Neuro-muscular problems
Organ perforation
Pain
Painful sexual intercourse
vagin*l scarring
vagin*l shrinkage (via scar tissue)

The research differs on the causes of serious mesh complications, but vagin*l exposure and mesh erosion are the most common. These can cause continued pain and require a second surgery to remove a portion of the mesh.

While nonabsorbable synthetic mid-urethral slings are the main surgical option for SUI, more data is needed on the serious complications possible. One study showed only a 32% corrective rate for an SUI surgery involving a mesh sling, while others found the rate of mesh-related complications was about 15% to 25%.

Reoperation for SUI Surgery Using Transvagin*l Mesh

Revision surgery removes or repairs transvagin*l mesh implants, but it’s complex and may cause significant pain compared to the initial mesh procedure. While these revision surgeries can ultimately have a positive effect on patient pain, there are no guarantees of total correction of mesh complications.

Those with a Prolift repair had fewer secondary surgery experiences. Those who underwent concurrent mid-urethral sling and complete POP repair with a hysterectomy had lower risks of secondary surgery.

Alternatives to Transvagin*l Mesh

Doctors may recommend a nonsurgical method to treat SUI or POP. Nonmesh treatments for SUI include both surgical procedures and non-surgical approaches.

Burch Colposuspension: The urethra is suspended and stabilized, suturing it into an elevated position above the bladder.
Pelvic Floor Therapy: These exercises strengthen the pelvic muscles and can help alleviate mild symptoms of SUI or POP.
Pessary: This is a small, plastic device that doctors insert into the vagin* to provide support to the organs and bladder.

Burch colposuspension is one of the earliest medical treatment options for SUI and POP. It’s still considered an effective technique.

Lawsuit Information

Transvagin*l mesh lawsuits have alleged that the devices caused complications including pain, bleeding, infection, organ perforation and autoimmune problems.

View Lawsuits

Are There Transvagin*l Mesh Lawsuits?

Across the country, lawyers are currently pursuing litigation for transvagin*l mesh complications. The exact number of cases pending across the nation is unknown. November 2022 saw the resolution of the last MDLs in West Virginia.

Plaintiffs won close to $ billion in 2019 from a number of settlements and verdicts for cases involving pelvic mesh for the treatment of pelvic organ prolapse or stress urinary incontinence. The conclusion of seven MDLs found Johnson & Johnson and Boston Scientific among those companies liable for mesh injury and damages.