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Transvaginal Mesh

Transvaginal mesh is a net-like implant that treats stress urinary incontinence and pelvic organ prolapse. It is most commonly used to support the vaginal wall, urethra or bladder neck. Complications with POP repair led the FDA to ban sales of mesh for this use in 2019.

Last Modified: March 21, 2024
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What Is Transvaginal Mesh?

Transvaginal 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 vaginal wall, urethra or bladder neck. Manufacturers typically make them from a plastic called polypropylene or from animal tissue.

Is Transvaginal Mesh Banned?

Transvaginal 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 transvaginal mesh devices. The FDA’s action did not apply to mid-urethral slings or in abdominal surgeries to support the vaginal wall.

FDA Actions
  • April 2019: The FDA orders manufacturers of transvaginal 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 transvaginal repair.
  • July 2011: The FDA issues safety communications regarding transvaginal 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 Transvaginal Mesh for POP supported the initial ban from the FDA.

Vaginal Mesh in Other Countries

Several countries issued bans and restrictions on transvaginal 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 circumstances.

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

In countries where restrictions are in place, exceptions include implants for research and clinical purposes. In some cases, the patient’s condition allows for the use of transvaginal mesh.

Are There Current Transvaginal Mesh Uses?

The FDA ruling banned transvaginal 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. Transvaginal mesh supports the urethra when pelvic muscles weaken.

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

Transvaginal Mesh Types

There are four categories of transvaginal 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 transvaginal 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 Transvaginal Mesh Implants

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

Transvaginal Mesh Products
  • Boston Scientific: Pinnacle Pelvic Floor Repair Kit, Uphold Vaginal 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 transvaginal mesh. Boston Scientific, however, issued a voluntary recall in 1999 on its ProteGen mesh.

Madris Tomes, founder of Device Events, shares which brands of mesh are more problematic than others.

Complications of Transvaginal Mesh

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

Transvaginal Mesh Complications
  • Bleeding
  • Infection
  • Mesh erosion
  • Nerve damage
  • Neuro-muscular problems
  • Organ perforation
  • Pain
  • Painful sexual intercourse
  • Vaginal scarring
  • Vaginal shrinkage (via scar tissue)

The research differs on the causes of serious mesh complications, but vaginal 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 Transvaginal Mesh

Revision surgery removes or repairs transvaginal 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 Transvaginal 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 vagina 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
Transvaginal mesh lawsuits have alleged that the devices caused complications including pain, bleeding, infection, organ perforation and autoimmune problems.
View Lawsuits

Are There Transvaginal Mesh Lawsuits?

Across the country, lawyers are currently pursuing litigation for transvaginal 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.

Please seek the advice of a medical professional before making health care decisions.