Vaginal mesh is touted as a “minimally invasive” method to treat pelvic organ prolapse and stress urinary incontinence. It can also come with life-altering complications. Thousands of adverse reactions, including three deaths, have now been linked to failed mesh.


The Truth

Studies + Science

Regulation Recap

The Next Steps
Vaginal mesh is implanted in hundreds of thousands of women each year.Researchers linked mesh to infections, urinary problems, bleeding, scarring, painful sexual intercourse and other serious side effects.The FDA recently reclassified transvaginal mesh from moderate-risk to high-risk.As the world becomes more conscious of mesh complications, community outreach and resources for survivors continue to grow.

 

 

A Twisted Truth

mt-vmesh-final-revaTransvaginal mesh, a medical netting commonly made of polypropylene, is inserted into the vagina to support collapsing pelvic muscles. Mesh is implanted in more than 500,000 women each year to manage conditions that develop after menopause, childbirth, or a hysterectomy.

Vaginal mesh is primarily used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). While some POP/SUI patients may be asymptomatic, others will experience pain, discomfort, and changes in quality of life. Some may also experience POP and SUI at the same time.

A woman’s estimated lifetime risk of POP is 30-50 percent. SUI affects an estimated 20-40 percent of women. Eleven to 19 percent of women will undergo surgery for prolapse or incontinence by age 80 to 85.

Pelvic organ prolapse occurs when the bladder, uterus, bowel or rectum drops or descends into the vaginal canal. POP mesh supports the organs from falling further past the pelvic floor. Some women may see or feel a vaginal bulge.

SUI, or unintentional bladder leakage, takes place when women engage in daily activities like running, lifting, laughing, coughing or sneezing. Also known as vaginal tape or bladder slings, SUI mesh treatments work with the urethra.

Mesh can be made from a synthetic, biological, or composite material, though the majority of gynecological products are made from non-absorbable synthetic polypropylene. The size and shape of each mesh device differ, but all materials contain large, flexible pores stitched together to solve feminine health problems.

Designed Differences of Mesh Materials

  • non-absorbable synthetic (e.g., polypropylene or polyester)
  • absorbable synthetic [e.g., poly(lactic-co-glycolic acid) or poly(caprolactone)]
  • biologic (e.g., acellular collagen derived from bovine or porcine sources)
  • composite (i.e., a combination of any of the previous three categories)

Meant to offer a better, simpler way to treat SUI and POP, the truth about transvaginal mesh strays far from the intention. New research shows vaginal mesh, awash with unnecessary risks, isn’t more effective than standard repair.

Thousands of complication reports and a rising number of lawsuits prove that vaginal mesh can wreak havoc on the body, leaving women to deal with severe physical pain, financial stress, and emotional anguish.

Studies + Science

There are a number of side effects linked to transvaginal mesh products, many of which are related to improper placement and repeated revision attempts. However, another issue in failed mesh cases is rooted in the psychology of women’s healthcare.

Women are taking to social media to spread awareness about the side effects they experienced to combat barriers to medical care. Some doctors have minimized women’s complaints, chocking up serious medical complications to sensitivity, stress or menopause. The lack of patient information and wait periods for timely treatment allows mesh complications to worsen over time.

One of the hardest parts of dealing with medical injuries is finding a place to start. But convincing a doctor that something is wrong shouldn’t be one of them. For women with SUI, POP, and transvaginal implants, awareness of the main mesh complications is essential.

Most common complaints from 2008-2010:

  • vaginal mesh erosion (also called exposure, extrusion, or protrusion)
  • pain (including painful sexual intercourse, known as dyspareunia)
  • infection
  • urinary problems
  • bleeding
  • organ perforation
  • recurrent prolapse
  • neuro-muscular problems
  • vaginal scarring/shrinkage
  • emotional problems
  • surgical treatment
  • hospitalization

Physical Side Effects

The most common vaginal mesh complication is erosion, which occurs when the mesh migrates from its original placement and moves into the vaginal wall. Also known as exposure, extrusion or protrusion, the mesh is then considered dangerous. Mesh erosion can require multiple revision surgeries and may leave women with ongoing pain, even after removal.

Based on data from 110 studies including 11,785 women, approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery.

Mesh has the possibility of causing organ perforation, which opens the body to inflammation and infection. Failed mesh can also lead to nerve damage, scarring, and extended bleeding. Over time, failed mesh can also fuse to organs and tissue. It becomes tangled in feminine parts, causing persistent pain, infection, and foul-smelling discharge.

Some women might not realize mesh has failed for weeks, months or even years. As time passes, device removal becomes increasingly difficult.

Emotional Side Effects

Failed mesh not only causes medical problems, it can diminish a woman’s quality of life. Dyspareunia, or pain during intercourse, affects the physical body, but can also have a deep psychological and emotional impact.

One study republished in the U.S. National Library of Medicine found rates of dyspareunia at nearly 25 percent after POP surgery. Survey responses reveal that when mesh complications turn sexual experiences from pleasurable to painful, it leads to relationship problems that may end in separation and divorce. Many women claim mesh destroyed their love lives.

Product Design and Placement

Mesh materials are soft, but the edges of the netting can poke through tissue when erosion occurs. As the material moves through the body, it can become a dangerously exposed irritant. Some mesh implants are designed to act as a permanent fix, which means the material becomes a part of the body.

There are multiple placement techniques and locations for vaginal mesh, including inside the anterior vaginal wall, posterior vaginal wall or attached to the top of the vagina. Doctors can utilize surgical techniques to place mesh in the abdomen, but it’s easier to insert the device into the vagina. One study, republished in the U.S. National Library of Medicine, reported incidences of bowel, bladder, and blood vessel perforation during insertion.

Although insertion kits do exist, the procedure is performed “blind.” This means that the surgeon cannot “directly visualize placement of the surgical mesh, and is reliant on the surgical instrumentation, palpation of anatomic landmarks, and experience,” according to the FDA.

New studies show that placement methods and operational training levels could be cause for concern. Improper placement techniques can lead to immediate complications that include trauma, bleeding, inflammation, rejection, hematoma, and organ injury, as well as long-term problems.

Data from a study published in Journal of the American Medical Association showed that inexperienced surgeons could increase the likelihood of mesh complications by 37 percent. Investigations of seven mesh-related deaths found that two bowel perforations and one hemorrhage were caused by the POP mesh placement. Four deaths were caused by post-operative mesh complications.

Revision and Removal

Failed mesh removal is tough. Doctors cut mesh from human tissue piece by piece, requiring patients to go under the knife for multiple revision surgeries. The development of scar tissue can prolong the process.

A study published in the Journal of the American Medical Association study found that 1 of every 30 women implanted with a mesh device for more than ten years would require a second removal or revision procedure.

In some cases, mesh is irretrievable. The quest to quell the pain, remove the device or reverse its complications can end up being extremely costly. Women may need to undergo multiple revision surgeries, many of which are unsuccessful.

In legal complaints, women produce evidence that shows mesh manufacturers knew about the risks and continued to market the device without altering the design.

Regulation Recap

The history of vaginal mesh exists within a complex web. Though vaginal mesh materials only received official approval 20 years ago, mesh began to make its way into gynecological healthcare in the ’70s.

The Making of Vaginal Mesh

Mesh products made it to the medical market in the 1950s, originally approved by the FDA to treat abdominal hernias. After thirty years, doctors began utilizing mesh in off-label surgeries to repair POP and SUI. Mesh became a treatment for POP in the 1970s. It was later used for SUI repair in the 1990s.

The demand for vaginal mesh sparked a change in supply, and mesh manufacturers started creating products specifically for female health. Because mesh had already been used in hernia repair, manufacturers conducted minimal trials before applying for FDA approval.

In 1996, the FDA approved Boston Scientific’s ProteGen Sling, which became the first mesh device to hit the market. Mesh products were given special consideration, moving through the expedited, less comprehensive 510(k) FDA approval program. The products were then packaged and sold as kits, complete with implantation instruments and instructions.

While bench and animal testing were used to measure the safety of mesh engineering specifications and biocompatibility, no clinical studies took place. The medical device was then cleared without clinical performance data.

Just three years later, in 1999, manufacturers recalled the first mesh product because it didn’t function properly. The product was linked to a higher rate of erosion. The recall of the ProtoGen Sling, which provided the basis for the approval of future mesh products, foreshadowed what would be a history of product problems and manufacturer irresponsibilities.

2008 FDA Safety Communication

In 2008, Manufacturer and User Device Experience (MAUDE) discovered that mesh had caused more than 1,000 side effects. The FDA acknowledged the dangers, but the safety announcement issued presented the complications as rare.

“Although rare, these complications can have serious consequences,” the FDA wrote.

Over the next three years, the FDA noticed a fivefold increase in the number of injuries caused by mesh. The high number of adverse events forced the regulatory agency to further investigate the device safety.

2011 FDA Safety Communication

The FDA searched Manufacturer and User Device Experience (MAUDE) reports from January 1, 2008 to December 31, 2010. The agency found 2,874 reports for surgical meshes, including reports of injury, death, and malfunctions. The organization’s communication asserted that 1,503 were associated with pelvic organ prolapse (POP) repairs, and 1,371 were related to stress urinary incontinence (SUI) repairs.

After conducting a review, the FDA decided to address growing concerns about the risk of vaginal mesh. Ultimately, the takeaway of the announcement was that women with mesh implants are likely to have some problems, and mesh may not be superior to traditional methods.

“The FDA determined that (1) serious adverse events are NOT rare, contrary to what was stated in the 2008 PHN, and (2) transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.

In the second communication, the FDA stated that:

  • Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
  • Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
  • There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
  • While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

2012 FDA Data Review

In 2012, the agency called on manufacturers to complete post-market surveillance studies. The organization issued 126 “section 522” orders to 33 manufacturers of transvaginal POP mesh products. The FDA then recruited a scientific advisory board to review the data.

The review garnered a new focus on patient labeling, informed consent, mandatory registration of implanted devices, surgeon training and credentialing and the development of a meaningful database.

2014 FDA Reclassification Proposal

The scientific community has come to a consensus that more research must be done to determine the safety of transvaginal mesh. In May 2014, the FDA submitted a proposal to alter the classification of transvaginal mesh repair from class II, or moderate-risk devices, to class III, or high-risk devices.

“Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide reasonable assurance of safety and effectiveness, and are purported or represented for a use in supporting or sustaining human life or for a use that is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury,” according to the FDA proposal.

2016 FDA Press Announcement

In January 2016, the FDA completed its final public safety orders to strengthen the data requirements for POP mesh. The device will now be considered a high-risk product. Mesh manufacturers will also be required to submit a premarket approval (PMA) application to demonstrate product safety and effectiveness by June 2018.

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

The Next Steps

The female form is a force of nature, powered by its own cycles and systems. From birth until death, women are faced with unique challenges to preserve their health. And for thousands of women, artificial additions like vaginal mesh can lead to a lifetime of complications.

Anti-Mesh Advocacy

The FDA issued a checklist of questions to encourage women undergoing mesh surgery to consider their options. The agency’s announcements have made significant waves in the medical and legal community. A New Jersey court ordered manufacturers pay $11 million to a mesh survivor.

In the digital sphere, women banned together to share their stories. Mesh manufacturers, held liable for not providing complete safety information, face thousands of legal actions. There are more than 30,000 mesh-related lawsuits moving through the U.S. court system.

The outpour of information has been supported by medical organizations, including the American College of Obstetricians and Gynecologists (ACOG), the Society of Gynecologic Surgeons (SGS), the American Urogynecologic Society (AUGS) and the Society for Female Urology and Urodynamics (SUFU).

The ACOG issued a statement on mesh, acknowledging the lack of well-designed trials to establish the safety and efficacy of these devices and the questionable success rates. The ACOG focuses on informing patients and requiring surgeons to have “a thorough understanding of pelvic anatomy and have training in the technique.”

“Patients need to be counseled that there are alternative native tissue repairs and that synthetic mesh is permanent,” the ACOG added. “Some patients may not realize that vaginal bleeding, pain, and dyspareunia may be related to vaginal mesh, and such reports should prompt a thorough vaginal examination, and an examination under anesthesia if needed.”

Moving Forward

The female body is one of the most sacred things on this Earth. As a woman and a human being, you have the right to know about each and every side effect. You have a right to choose whether the risk is worth it, and you have a right to the truth.

If you’re one of the millions of women feeling like your failed mesh is a foreign invader, you’re not alone. The story is still unfolding and we’re here to keep you informed.

When you’re ready, we’ll connect you with a community of advocates who can help you understand available resources. You’re not a victim of mesh. You’re a survivor.

And it’s your right to control your body and your future.