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Transvaginal Mesh

Transvaginal mesh is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women. The product design and implantation technique contributed to serious complications, such as erosion and organ perforation. The FDA classifies transvaginal mesh as a high-risk device, but some surgeons continue to use it.

*Please seek the advice of a medical professional before discontinuing the use of this medical device.

Transvaginal Mesh Implant and pelvic bone

What is Transvaginal Mesh?

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.

10,000 women filed suits worth $1bil 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

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

  • 1996

    First transvaginal mesh device approved for SUI

  • 1999

    ProteGen Sling recalled because of safety concerns

  • 2002

    First transvaginal mesh product for POP approved

  • 2008

    First public health safety notification about mesh

  • 2011

    Public health safety notification updated and strengthened

  • 2011

    FDA panel on mesh held

  • 2012

    Mesh makers ordered to conduct post-market studies

  • 2014

    Proposal to reclassify mesh devices issued

  • 2016

    Transvaginal mesh for POP reclassified as high-risk

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.

Johnson & Johnson / Ethicon

  • Gynecare Prolift Kit
  • Gynecare TVT Secur
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift + M Kit

C.R. Bard

  • Avaulta Solo
  • Avaulta Plus
  • Align Urethral Support System
  • Pelvilace Support Systems
  • Uretex Urethral Support Systems

Endo / American Medical Systems

  • Perigee
  • InteXen
  • IntePro
  • MiniArc Slings
  • Bio Arc Slings
  • Monarc Slings

Boston Scientific

  • Pinnacle Pelvic Floor Repair Kit
  • Uphold Vaginal Support System
  • Advantage
  • Obtryx Slongs

Coloplast

  • Minitape
  • Aris Transobturator Sling
  • Omnisure
  • Novasilk Sling

Mentor

  • ObTape

In June 2012, amid mounting legal pressure and growing concern from the FDA, Ethicon announced that it would no longer manufacture and distribute vaginal mesh products. C.R. Bard has also withdrawn mesh products from the market. However some companies, including Boston Scientific, continue to make and sell transvaginal mesh products.

What Transvaginal Mesh Treats

Doctors use transvaginal mesh because there are few alternative treatments for symptomatic pelvic organ prolapse or stress urinary incontinence. Symptomatic refers to patients experiencing pain, discomfort or other unpleasant symptoms of the conditions. Some patients are asymptomatic. They require no treatment, or conservative treatments cause relief. When conservative treatments don’t work, doctors have few reliable options to choose from.

pelvic prolapse icon

Pelvic Organ Prolapse (POP)

Pelvic organ prolapse occurs when organs sag or fall into the vaginal canal because of weak pelvic muscles. Transvaginal mesh serves as a hammock beneath the organs to hold them up. Usually, the bladder, uterus, rectum or bowel is involved in the prolapse. The bladder is the most common organ affected. Depending on the organs involved, surgeons may place the piece of mesh on the front, back or top wall of the vagina. The type of mesh used also varies in shape and size. This type of surgery is usually performed transvaginally.

stress urinary incontinence icon

Stress Urinary Incontinence (SUI)

Stress urinary incontinence (SUI) occurs when the bladder leaks urine during moments of increased physical activity that increases pressure on the bladder. The mesh is used to support 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 condition. An estimated 80 percent of SUI mesh surgeries in 2010 were done through the vagina. Doctors use transvaginal placement of bladder slings because it is considered less invasive and the incisions are smaller.

hysterectomy icon

Hysterectomy

After a hysterectomy, some women suffer from vaginal vault prolapse. The condition occurs when the vagina collapses in upon itself because of the removal of the uterus. Mesh is surgically implanted on the top of the vagina and sewn into connective tissues to hold the vagina in place

Side Effects, Complications and Revision Surgery

Transvaginal mesh operations usually result in minor pain or discomfort for a few days after the operation. Bleeding may occur for a few hours after surgery, but most women leave the hospital on the same day as the procedure. Patients usually resume everyday activities, including sexual intercourse, within one to three months of the operation. Although transvaginal mesh surgery is simpler and less invasive than more traditional treatments for POP and SUI, it also carries a higher complication rate. In 2011, the FDA reported that it had received 4,000 reports of complications related to transvaginal mesh during the previous six years.

Serious Complications Caused by Transvaginal Mesh

Although transvaginal mesh surgery is simpler and less invasive than more traditional treatments for POP and SUI, it also carries a higher complication rate. In 2011, the FDA reported that it had received 4,000 reports of complications related to transvaginal mesh during the previous six years.

Complications from transvaginal mesh include:

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

Researchers have tried to determine how often transvaginal mesh implants cause serious complications, but studies have produced differing results. Complication rates range from 7 percent to 21 percent.

Revision Surgery for Mesh Complications

Severe complications, such as mesh erosion and organ perforation, may require surgery to fix. This surgery is referred to as revision surgery. Synthetic surgical mesh was designed to stay in the body indefinitely, so removal of the mesh is difficult. Blood vessels and tissues grow around the mesh, requiring doctors to remove it in pieces, one surgery at a time.

Urogynecologists receive special training in pelvic floor disorders, such prolapse and incontinence. They’re the most qualified surgeons to perform transvaginal mesh revision surgeries.

Other Treatments for Mesh Complications

In some cases, doctors try alternative methods to mesh removal. Doctors may prescribe vaginal estrogen cream to help the walls of the vagina heal on their own and manage symptoms, particularly if a woman is not sexually active. Then, she can follow up every few months to observe the erosion and make sure it doesn’t worsen.

If only a small amount of mesh is exposed, doctors may simply trim off the piece with a local anesthetic. Typically this is an option when the amount exposed is 5mm or less. This is a less complex form of surgery than complete mesh removal.

Alternatives to Transvaginal Mesh Implants

If women do not wish to receive transvaginal mesh, or if they don’t qualify for surgery, they may pursue alternatives. Some doctors may try nonsurgical, conservative methods to treat POP or SUI before pursuing surgery. If surgery is necessary, there are also techniques that do not use mesh.

Treatments that do not use mesh include:

  • Pessaries: A pessary is a small, plastic device inserted into the vagina to provide support to the organs and bladder. Doctors teach women how to insert a pessary, and it is recommended for women who still want children, do not want surgery or are not optimal candidates for surgery. These devices are typically made of inert plastic or silicone.
  • Pelvic floor therapy: In addition to Kegel exercises, pelvic floor physical therapy can strengthen the pelvic muscles and improve prolapse or stress urinary incontinence symptoms in mild cases.
  • Surgery without mesh: The patient’s own tissue can be used to treat POP or SUI. Slings composed of a tissue have a higher rate of complications during surgery than synthetic mesh, and they have a higher rate of symptom recurrence. However, they have fewer serious long-term risks than synthetic mesh.

It’s impossible for a doctor to determine a patient’s risk for mesh erosion, infection or other complications from transvaginal mesh. Mesh has several advantages to more conservative treatments. It can treat serious symptoms that conservative options can’t treat. It also has a lower rate of short-term surgical risks, such as infection, than some other surgical treatments.

However, transvaginal mesh has the highest risk of serious long-term complications. Patients considering surgery for SUI or POP, or those considering a hysterectomy, should ask their doctors about the implant that they’re receiving. They should also discuss the benefits and risks of complications with the devices.

Author

Chris Elkins is a writer and researcher for Drugwatch.com. He’s worked for various newspapers and has writing experience in sports, health communication and public relations fields.

View Sources
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