Transvaginal mesh is a net-like implant used to treat stress urinary incontinence and repair pelvic organ prolapse in women. After receiving reports of serious complications, such as erosion and organ perforation, the U.S. Food and Drug Administration in 2016 classified implants for POP as high-risk devices. In 2019, the FDA ordered mesh manufacturers to stop selling their POP products immediately.
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 surgical 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.
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 3 device.
Then in April 2019, after the agency did not find evidence that the benefits outweighed the risks, it ordered manufacturers to stop selling mesh for POP.
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 mesh devices banned. Professional organizations, such as the American Urogynecological Society, continue to stand by pelvic mesh as a treatment option.
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.
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 had mesh for 11 years.
“[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.”
Ultimately, 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.
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. 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 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.
Some 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 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 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 also conducted a systematic review of the scientific literature to learn more about the safety and effectiveness of POP and SUI using surgical mesh,” the agency said in its 2011 Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse. “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.”
As of January 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.
- Nerve damage
- Vaginal scarring
- 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. The rate of mesh-related complications is about 15 percent to 25 percent, according to a 2015 article by researchers Dimitri Barski and D.Y. Deng in BioMed Research International.
In some cases, women need revision surgery to remove problematic mesh. In most cases, specialized doctors called urogynecologists have the most training in removing these 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.
- 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.
Media and Research Controversy
Transvaginal mesh has had a history of 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.
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.
Please seek the advice of a medical professional before making health care decisions.