Transvaginal mesh is a net-like implant used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Doctors rely on transvaginal mesh to reinforce a weakened vaginal wall or support the urethra or bladder neck. In 2019, after patients reported serious complications, the FDA banned sales of all mesh products used for POP repair.
Transvaginal mesh is a net-like medical device that doctors use to repair weakened or damaged tissue in a woman’s bladder or pelvic area. The word “transvaginal” refers to the surgical technique doctors use to implant the mesh through the vagina.
Manufacturers typically make these meshes from a plastic called polypropylene, though some meshes may use animal tissue. Surgeons use this type of surgical mesh to permanently fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Transvaginal mesh products evolved from surgical mesh originally used in the 1950s to repair abdominal hernias. Surgeons began using the mesh abdominally to repair POP in the 1970s. By the 1990s, gynecologists were using mesh for surgical treatment of SUI and transvaginal repair of POP.
Medical device manufacturers noticed the clinical practice and responded by creating mesh products specifically designed to treat SUI and repair POP. The FDA cleared the first mesh for SUI in 1996 and the first mesh for POP in 2002.
“It’s an inert material that’s used in wide variety of situations like in men for hernias,” Dr. Gopal H. Badlani, professor and vice chair of urology at Wake Forest School of Medicine, told Drugwatch. “General surgeons use it in abdominal wall repair hernias. Gynecologists and urologists use it abdominally, so it’s the same product being used in different places. But it’s the approach vaginally that causes problems in terms of how it’s placed, and of course it doesn’t heal, so you know the technique of dissecting the vaginal flaps or the wall of the vagina, how you separate and put the mesh in makes a huge difference. Even incision size makes a huge difference.”
According to the FDA, doctors performed approximately 260,000 mesh surgeries for urinary incontinence in 2010. These surgeries are successful at one year after surgery in 70 percent to 80 percent of women, according to the agency.
Doctors in the United States performed about 300,000 surgeries for POP in 2010. At the height of synthetic mesh use in 2006, one-third of all POP surgeries used mesh. After the FDA began issuing warnings for complications in 2008 and 2011, synthetic mesh use declined, Dr. Cheryl B. Iglesia told MD Edge.
The FDA focused its regulatory efforts on transvaginal mesh for POP, a procedure that the agency finds more risky. In 2016, it classified mesh for POP as a high-risk, class III device.
Then in April 2019, the FDA ordered manufacturers to stop selling all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse. The agency said it did not find sufficient evidence to assure that the probable benefits of these devices outweighed the probable risks.
Although the FDA required manufacturers to withdraw POP mesh from the market, no manufacturer has recalled a transvaginal mesh device since Boston Scientific recalled its ProteGen Sling in 1999.
The FDA’s action did not apply to midurethral slings, which is a mesh that’s used for the urethra alone, nor did it apply to mesh placed abdominally using a robotic approach, said Badlani, who serves as director of the female public health unit at Wake Forest.
“So it was specifically related to the kits produced by certain companies that were marketed and there was a rate of complications related to the mesh that brought on this FDA warning,” he said.
Thousands of women have filed lawsuits against mesh makers, claiming the devices caused serious complications. So far, several device companies, including Johnson & Johnson and Boston Scientific, have agreed to pay about $8 billion to resolve more than 100,000 claims, The New York Times reported.
Patients who say they were harmed by the device want all transvaginal mesh devices banned. Professional organizations, such as the American Urogynecological Society, continue to stand by pelvic mesh as a treatment option.
“The use of mesh in the vaginal approach has remained controversial that some favor it for its outcomes and others are vehemently against it because of these specific complications related to the mesh use,” Badlani said. “In my practice, there is a high use of mesh. I have two colleagues in my same unit that don’t believe in the use of the mesh, so they hardly use the mesh vaginally.”
Using Transvaginal Mesh for Incontinence or Prolapse
Doctors use transvaginal mesh for symptomatic pelvic organ prolapse or stress urinary incontinence. Symptomatic refers to patients experiencing pain, discomfort or other unpleasant symptoms.
Some patients are asymptomatic, and they may not require treatment, or conservative treatments may provide relief. But when conservative choices such as observation, pelvic floor rehabilitation or pessaries don’t work, doctors may recommend mesh surgery.
Pelvic Organ Prolapse
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 commonly affected organ.
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.
Another type of prolapse is called vaginal vault prolapse. The condition occurs most often after a hysterectomy. The vagina collapses in upon itself because of the removal of the uterus. Surgeons implant mesh on the top of the vagina and sew it into connective tissues to hold the vagina in place.
Doctors may sometimes refer to transvaginal mesh that repairs POP as synthetic mesh, a graft, a patch, biomesh or a vaginal support system.
Stress Urinary Incontinence
Stress urinary incontinence occurs when the bladder leaks urine during moments of greater physical activity that increase pressure on the bladder. The mesh supports 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. Doctors use transvaginal placement of bladder slings because it is minimally invasive and the incisions are small.
Mesh Types, Manufacturers and Brands
The FDA categorizes mesh into four categories for gynecological use based on how the mesh reacts inside of the body.
- Non-Absorbable synthetic
- Non-Absorbable synthetic meshes are made from synthetic materials, such as plastic or polyester. Most mesh devices are made of polypropylene.
- Absorbable synthetic
- The body absorbs absorbable synthetic mesh, and tissue grows at the implant site. This helps strengthen the ligaments in the pelvis.
- Biologic meshes are 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 is 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.
At one time, several companies made transvaginal mesh for POP repair. Since the FDA reclassified POP mesh in 2016 and required more safety studies, many companies have stopped making it.
Before the FDA banned sales of all remaining POP mesh in April 2019, the last three surgical mesh products for anterior compartment prolapse were Boston Scientific’s Uphold LITE Vaginal Support System, Boston Scientific’s Xenform Soft Tissue Repair System and Coloplast’s Restorelle DirectFix Anterior.
“Currently, there is no kit available to use for the anterior vaginal repair,” Badlani said. “Of course free mesh is available if a person chooses to use free mesh along with other anchoring techniques.”
Examples of mesh brands include:
- Gynecare Prosima Pelvic Floor Repair System
- Gynecare Prolift Kit
- Gynecare TVT Secur
- Gynecare Prolift + M Kit
- Avaulta Solo
- Avaulta Plus
- Align Urethral Support System
- Pelvilace Support Systems
- Uretex Urethral Support Systems
- MiniArc Slings
- Bio Arc Slings
- Monarc Slings
- Pinnacle Pelvic Floor Repair Kit
- Uphold Vaginal Support System
- Obtryx Slings
- Aris Transobturator Sling
- Novasilk Sling
Complications and Revision Surgery
Although transvaginal mesh surgery is 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 2,874 reports of injury, death, malfunctions and other complications related to mesh from Jan. 1, 2008 to Dec. 31, 2010.
“The FDA determined that (1) serious adverse events are NOT rare, contrary to what was stated in the 2008 [Public Health Notification], and (2) transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.”
The FDA conducted a systematic review of scientific literature to learn more about the safety and effectiveness of using surgical mesh for transvaginal repair of POP and SUI.
“The FDA determined that (1) serious adverse events are NOT rare, contrary to what was stated in the 2008 [Patient Health Notification], and (2) transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair,” the agency said in its 2011 Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.
As of Jan. 31, 2019, the agency had received 69,000 adverse events reports for POP mesh products, according to Device Events CEO Madris Tomes. Of the reports, 64,600 cited injuries, and 393 patients died.
- Mesh erosion
- Nerve damage
- Neuro-muscular problems
- Organ perforation
- Painful sexual intercourse
- Vaginal scarring
- Vaginal shrinkage (via scar tissue)
Researchers have tried to determine how often transvaginal mesh implants cause serious complications, but studies have produced differing results. Dimitri Barski and D.Y. Deng conducted a review of current literature and found the rate of mesh-related complications is about 15 percent to 25 percent, according to their article published in 2015 in BioMed Research International.
Vaginal exposure is the most common mesh-related complication requiring a second surgery to remove a portion of the mesh, Badlani said. Also known as erosion, extrusion or protrusion, the complication occurs when the mesh wears through tissue and becomes visible through the vagina, according to the FDA. Less common complications involve the mesh going into the bladder, the urethra or the rectum, depending on where the mesh is being placed.
Vaginal mesh erosion can require multiple surgeries to correct and may result in continued pain after the mesh is removed, according to the FDA.
“More than half of the women who experienced erosion from non-absorbable synthetic mesh required surgical excision in the operating room. Some women required two to three additional surgeries,” the agency said, citing a literature review that identified safety concerns with transvaginally placed surgical mesh for POP repair.
Badlani said his practice has shifted toward dealing with mesh complications rather than doing primary mesh repair. He said he has treated hundreds of patients who have come to him with complications related to mesh placed by other surgeons. He estimated he performs roughly 20 surgeries a year related to mesh removal or mesh complications, and the unit he oversees handles 50 to 60 mesh-related cases a year.
How much these complications interfere with a women’s daily life depends on her age and whether she is sexually active, Badlani said. For example, vaginal intercourse may become painful and/or not possible both from partner discomfort or patient discomfort.
“That affects their quality of life, and of course they need to have a secondary procedure, so that’s adding to the cost of care,” Badlani said.
Some doctors may try nonsurgical, conservative methods to treat POP or SUI before pursuing surgery or when surgery is not an option.
- 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. 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.
Synthetic Mesh Versus Natural Tissue Repair
Surgeons started using mesh to repair prolapse and treat incontinence because of a high rate of failure with natural tissue repairs. According to Badlani, longevity of success and decreased recurrence are two main benefits of using transvaginal mesh.
“You can use your own tissue to do the repair, but you’re likely to fail roughly 30 percent of the time with prolapse and 40 to 50 percent of the time with incontinence surgery if you use your own tissue because the science — and we have several articles on the science — [shows] your tissue is not healthy, and it’s going to break down,” Badlani said. “So if I take the same defective tissue and repair, it will likely fail. So then the alternative is to use the mesh where you’re risk of complications is in that 3 to 10 percent range.”
But the failure has different implications in non-mesh and mesh cases, Badlani said.
“In mesh-related complications you almost always have to have the second surgery to deal with the complication, whereas the failed prolapse surgery a women may choose to live with the prolapse and not do the second surgery although the procedure failed,” Badlani said.
Doctors and their patients also have to weigh the benefits and risks of performing the surgery vaginally. Among the benefits of vaginal placement of mesh are reduced morbidity compared to traditional surgery and the fact that it is an outpatient surgery, Badlani said.
“Vaginal surgery is way less morbid compared to an abdominal surgery. Even with the robot there is a higher need of anesthesia and all that, so it’s easy to say everybody can be repaired. But you take an 80-year-old that I need to put to sleep, and done robotically and abdominally, she is at a higher risk than doing vaginally, which is a day surgery,” Badlani said.
Media and Research Controversy
In December 2017, a review published in the BMJ Open revealed that 61 manufacturers sold mesh implants without clinical trials. Review authors said the safety and effectiveness evidence was weak.
According to the review, manufacturers were able to get their devices on the market by using an FDA process called the 510(k) process. The 510(k) allows manufacturers to sell products if their device is “substantially equivalent” to an existing device.
In the case of transvaginal mesh, the majority of devices were cleared for sale based on two devices: Ethicon’s Mersilene Mesh and Boston Scientific’s ProteGen Sling, a product that was recalled in 1999 for safety concerns.
Also in December 2017, a BBC Panorama investigation revealed Johnson & Johnson’s Ethicon division failed to properly warn doctors of the risks of transvaginal mesh in the U.K. and inadequately tested its devices before selling them.
“The [BBC Panorama] investigation also claimed that Ethicon launched a mesh implant product — the TVT-Secur implant — after testing it only in 31 women for five weeks, and in sheep.”
“The investigation also claimed that Ethicon launched a mesh implant product — the TVT-Secur implant — after testing it only in 31 women for five weeks, and in sheep,” the Guardian wrote about the investigation. “It was withdrawn in 2012 after six years on the market.”
A May 2018 report by 60 Minutes revealed Boston Scientific used untested counterfeit plastic in its mesh products. In 2005, Boston Scientific’s plastic supplier, Chevron Phillips, said it would no longer provide the material to make mesh.
Chevron Phillips told Boston Scientific that Marlex was not for “permanent implantation in the human body.” It told the device maker, “We are simply not interested in this business at any price.”
Boston Scientific wanted to keep manufacturing its profitable product. So, the company found a counterfeit Marlex supplier in China. But, the Chinese plastic was inferior to true Marlex plastic. Experts told 60 Minutes that mesh made from that plastic would only last a few months.
In early 2019, Boston Scientific weighed in on the controversy over its products.
“Our mesh products meet rigorous internal safety standards as well the standards of the FDA and other regulatory bodies, and international standards,” the company said on its website.
Is Mesh Still Used in Prolapse Surgery?
After hearing testimony from patients and reviewing safety and efficacy data from manufacturers, the FDA decided in April 2019 that mesh products for POP “do not have reasonable assurance of safety and effectiveness.”
Though no FDA-approved mesh devices for POP are available in the United States, devices for SUI still remain on the market.
Badlani said he and other doctors in his practice continue to use mesh with the appropriate informed consent of the patient. They discuss the pros and cons with patients and inform them about the FDA warning, and then they let the patients choose what they want. He said training in doing the procedure is paramount, and centers that perform a larger number of mesh procedures have a lower rate of complications.
“Evidence is collected by experience, and evidence shows that yes there is 3 to 10 percent [rate of complications], depending on sling versus prolapse, but at its worst 10 percent, you’re still having 90 percent success,” Badlani said. “So you will deny a product to 90 percent of women because of 10 having complications. And by no means am I minimizing the 10 who have to undergo a second procedure, but you have to look at every procedure that we do surgically — there is a benefit and then there is a possible drawback.”
While thousands of women with POP say mesh harmed them, others like Sherrie Palm, founder of the Association for Pelvic Organ Prolapse Support, are mesh success stories. She has lived with mesh inside her for more than a decade.
“[M]y heart goes out to the women with mesh complications,” Palm said at the FDA Obstetrics and Gynecology Devices Panel meeting on Feb. 12, 2019. “I’ve spent considerable time communicating with many of them, and it is pivotal that we listen to their voices. However, eliminating beneficial procedures from POP treatment options that benefit the majority of women is not the answer.”
Diana Zuckerman, president of the National Center for Health Research, told Drugwatch in an emailed statement that the FDA made the right decision when it ordered manufacturers of all remaining transvaginal mesh devices for pelvic organ prolapse repair to stop selling their products. She said it is well known that surgical mesh can cause serious and painful complications.
“We agree with the FDA that it should not be approved for use in procedures where there are no benefits compared to surgery without mesh,” she said.
Mesh in Other Countries
In November and December 2017, three countries issued bans on transvaginal mesh because of public concern and reports of complications. The first country to issue a ban was Australia. New Zealand and the U.K. followed, but only New Zealand has a complete ban on all transvaginal mesh for gynecological uses.
NOV. 28, 2017
Australia issued a ban on transvaginal mesh for prolapse and some bladder slings for incontinence. The country’s Therapeutic Good Administration said benefits do not outweigh the risks.
DEC. 11, 2017
New Zealand’s Medsafe agency issued a ban on transvaginal mesh for all gynecological uses, including prolapse and incontinence. The agency said benefits do not outweigh the risks.
DEC. 15, 2017
The U.K.’s National Institute for Health and Care Excellence recommended a ban on transvaginal mesh for prolapse. It said the device should only be used for research purposes because of possible complications.
July 10, 2018
National Health Services (NHS) England put a temporary pause on all mesh operations, BBC News reported. The pause may be lifted, pending further investigation.
Badlani called the bans an “overboard reaction.”
“The British guidelines tell you just like our U.S. guidelines to use appropriate caution,” he said. “The news travels ahead of scientific data, so there’s a lot of emotional response against the true evidence.”
But patients like Justine Watson, who traveled from Australia to the United States to have her mesh removed, say some of the bans don’t go far enough.
“The [Australia] mesh ban doesn’t include the one that poisoned me,” Watson said. “I was sold a defective product and implanted by a poorly trained surgeon. It ruined seven years of my life and cost me my career.”
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