Transvaginal surgical mesh is a medical device implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Complications associated with transvaginal mesh have led to FDA warnings, device recalls, and personal injury lawsuits.
Transvaginal mesh litigation is one of the largest mass torts in history.
Many women experience SUI and POP as a result of childbirth, hysterectomy, or aging. While a number of surgical procedures can address these conditions, the insertion of mesh through the vagina is thought to provide benefits over other types of surgeries. A growing body of evidence, however, suggests that transvaginal mesh can cause serious health problems, including severe pain, organ perforation, and tissue erosion.
More than 100,000 vaginal mesh lawsuits have been filed, and millions of dollars in compensation have been awarded to women harmed by mesh.
About Transvaginal Mesh
“Transvaginal” refers to the insertion of mesh through the vagina (rather than through an abdominal incision).
Surgical mesh has been used since the 1950s to repair abdominal hernias. Gynecologist began using mesh to treat POP in the 1970s and in the 1990s to treat SUI. Because the mesh made at this time wasn’t designed specifically for POP and SUI repairs, doctors cut mesh products to shape.
Transvaginal mesh was initially marketed as providing improved surgical success rates and time-saving, minimally invasive procedures.
These new uses for surgical mesh prompted manufacturers to introduce mesh specifically intended for POP and SUI surgeries. Boston Scientific’s ProteGen Sling, cleared by the FDA in 1996, was the first of these new surgical meshes to hit the market. The following year the first mesh “kit”—consisting of pre-shaped mesh in addition to special tools and instructions for insertion—was introduced.
From 1992 to 2000 FDA cleared 25 transvaginal mesh products indicated for POP and SUI repair. From 2001 to 2010 the agency cleared 143 transvaginal mesh products for these uses.
As more and more vaginal mesh kits hit the market mesh was used in an increasing number of transvaginal POP and SUI repairs. This led to dramatic changes in how these surgeries are performed—and a huge uptick in mesh complications.
Pelvic Organ Prolapse
The pelvic floor is a group of muscles that hold the pelvic organs in place. These organs include the bladder, uterus, rectum, cervix, and vagina. Pelvic floor muscles can tear or stretch due to childbirth or weaken with age. When this occurs the pelvic organs drop from their normal positions.
Pelvic organ prolapse isn’t always symptomatic but can lead to pelvic pressure, backache, bleeding, urinary incontinence (leakage), bowel problems, sexual difficulties, and the sensation of something falling out of the vagina or rectum.
Surgical mesh inserted through the vagina acts like a sling, or hammock, to hold sagging pelvic organs in place.
Stress Urinary Incontinence
Stress urinary incontinence occurs when the bladder leaks urine during coughing, sneezing, laughing, exercise, and other types of physical exertion. This is caused by the weakening of pelvic muscles that support the bladder and urethra. Weakness can be caused by pregnancy, childbirth, aging, and certain types of pelvic surgery.
Transvaginal mesh can be implanted to support the urethra or bladder in order to treat SUI.
Commercial Interests Trump Patient Safety
Transvaginal mesh shows how patient safety suffers when the interests of device manufacturers, and not clinical data, drive surgical practice.
Dr. L. Lewis Wall, a critic of transvaginal mesh, wrote in 2010 that “powerful commercial interests are reshaping the field of pelvic surgery.” The popularity of vaginal mesh kits, said Wall, “hold the promise of quick, easy, standardized operations; higher surgical volumes; and increased profits for both the surgeon and the device manufacturer.”
Wall goes on to describe how transvaginal mesh kits are not required to undergo clinical testing in human subjects. Boston Scientific’s ProtoGen Sling, for example, “had never been used in urologic operations or implanted in a human vagina prior to its clearance.”
FDA admits that its “premarket notification review process did not request original clinical studies to support clearance of surgical mesh indicated for treatment of SUI or POP.”
The ProtoGen Sling gained approval based on a 90-day rat study and its similarity to mesh used for cardiovascular surgery. But “the fact that no data on the product’s safety and efficacy…existed prior to its sale did not deter commercial exuberance,” says Wall.
Less than two years after its approval, the ProtoGen Sling was pulled from the market due to a high complication rate. Despite this, the recalled ProtoGen Sling was used as the basis for approving another transvaginal mesh product made by Johnson & Johnson.
This was made possible through an FDA fast-track approval process known as “510(k).” The 510(k) process allows device manufactures to gain marketing approval for new devices without clinical studies in human patients if they are said to be “substantially equivalent” to devices already on the market. Through this process, an approved device—even one that’s dangerous—can be used as the basis for a second, a third, a fourth, and so on.
Once a manufacturer gains approval to sell a device, according to Dr. Wall, it will do everything possible to maximize sales regardless of whether or not the use of the devices is actually in the best interest of patients. “Under these circumstances,” says Wall, “the interests of patients are subordinated to the profit motive and the interests of company shareholders.”
Types of Transvaginal Mesh
FDA divides surgical mesh materials into four categories:
- Non-absorbable synthetic (including polypropylene and polyester)
- Absorbable synthetic
- Biologic (including collagen derived from cow or pig)
- Composite (a combination of any of the above three categories)
FDA estimates that more than half of transvaginal mesh on the market is made from non-absorbable synthetic materials, with polypropylene the predominate material in 9 out of 10 of these devices. About 1/3 of approved transvaginal mesh devices are made from biologic-based materials.
Lawsuits allege that transvaginal mesh materials are not biologically compatible with human tissue, prompting an immune response in a significant subset of the population implanted with mesh products, promoting degradation of the mesh and contributing to severe adverse reactions to the mesh.
FDA Warnings About Transvaginal Mesh
The FDA in 2008 and 2011 warned about serious complications associated with transvaginal mesh, including:
- Mesh exposure into the vagina, bladder, or rectum
- Mesh erosion into the bladder or rectum
- Painful sexual intercourse
- Bowel, bladder, and blood vessel perforation
- Urinary problems
- New onset of POP/SUI
- Vaginal scarring/shrinkage
- Neuro-muscular problems
- Repeat surgery due to complications
From 2005 to 2010 FDA received roughly 4,000 reports of complications associated with transvaginal surgical mesh. The most common complaints were of mesh erosion and pain. Some of the injury reports (particularly bowel, bladder, and blood vessel perforations) were associated with the special tools used in transvaginal mesh placement. From 2008 to 2010, 7 deaths associated with transvaginal mesh were reported to FDA.
The agency’s 2011 warning, accompanied by a systematic review of the scientific literature on transvaginal mesh, came to the following conclusions:
- Serious complications associated with transvaginal mesh are NOT RARE
- It is not clear that transvaginal mesh surgery is superior to traditional non-mesh surgery
- Transvaginal mesh surgery may expose patients to greater risk than traditional non-mesh surgery
- Mesh used for transvaginal POP repair presents risks not present in traditional (non-mesh) POP repair surgery
- Mesh insertion may place patients at risk for requiring additional surgery or new health complications
FDA based these conclusions on 60 scientific articles, including 22 randomized controlled trials (considered the “gold standard” of scientific studies) performed after the devices went to market. It stands to reason that, had similar studies on transvaginal mesh been performed prior to marketing, device complications would have been observed much earlier, possibly preventing many patient injuries.
Mesh Complications Not Easy to Resolve
Because transvaginal mesh is designed as a permanent implant, removing it entirely can prove challenging (if not impossible), create new complications, and impair the patient’s qualify of life, according to the FDA.
One patient compared mesh removal surgery to “removing gum from your hair.”
Over time tissue grows into and around the mesh, which makes removing the mesh without damaging surrounding tissue and organs a very delicate process. Numerous surgeries are typically required to remove the mesh entirely, but complete removal of the mesh may not be possible and may not result in complete resolution of mesh complications.
One patient compared mesh removal surgery to “removing gum from your hair.” Six women who testified at an FDA hearing on mesh estimated that between them, they had undergone close to 50 procedures to try and undo the damage from the devices.
Transvaginal mesh removal varies depending on a woman’s individual circumstance and the type of mesh or mesh kit used in the original surgery. Patients who require revision surgery for transvaginal mesh should make an appointment with a doctor known as an urogynecologist.
The following companies have been named in transvaginal mesh lawsuits:
- American Medical Systems
- Boston Scientific
- Cook Medical
- CR Bard
- Johnson & Johnson
Transvaginal Mesh Lawsuits
More than 100,000 women and their families have filed lawsuits against transvaginal mesh manufacturers. The bulk of these claims are contained in seven multidistrict litigation (MDL) cases in West Virginia Federal court. Thousands of cases are also pending in state courts.
Mesh lawsuits allege that device makers used subpar materials and failed to warn about possible complications, resulting in severe and painful injuries to patients. Manufacturers have already paid out hundreds of millions of dollars in awards and are expected to pay much more before the litigation concludes.