This type of surgical mesh was created to permanently fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI) – conditions that typically plague women after a hysterectomy, menopause or childbirth. Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs — including the bladder, rectum and uterus — drop into the vagina.
Doctors can surgically place the mesh transvaginally or abdominally, but inserting the mesh through the vagina is quicker, easier and less invasive.
While these products were created to help women suffering from SUI and POP, not all of them are safe and reliable. The design and manufacturer-recommended implantation technique of some of these transvaginal mesh products contributed to serious complications 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. Nearly 23,000 lawsuits filed by women injured by mesh are pending in the U.S. District Court for the Southern District of West Virginia. Additional lawsuits are pending in state courts.
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History of Transvaginal Mesh
Transvaginal mesh products evolved from surgical mesh originally used for hernia repair in the 1950s. Surgeons began using the mesh abdominally to repair POP and SUI in the 1970s before products were developed specifically to treat these conditions. 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 took notice of this clinical practice and responded by creating mesh products specifically designed to treat POP and SUI.
Boston Scientific manufactured the first transvaginal mesh device, called the ProtoGen Sling. In 1996, the U.S. Food and Drug Administration (FDA) approved the device for the surgical treatment of SUI through the 510(k) premarket program. However, just three years after the product was released, it was recalled over safety concerns.
In 1998, the use of mesh for SUI repair – also referred to as slings or tape – became more common with the release of Ethicon’s Tension-Free Vaginal Tape (TVT). The first surgical mesh product specifically designed for POP repair – Gynemesh PS – was released in 2002 by Johnson & Johnson’s Ethicon unit.
As the usage of these products became more common, manufacturers began selling their mesh products in “kits.” These kits are prepackaged with mesh, special tools and instructions to help doctors implant it.
The first kits for SUI were cleared for sale in 1997, followed by the first POP kits – the AMS Apogee and AMS Perigee, both manufactured by American Medical Systems.
Some doctors, like urogynecologist Dr. Christopher Walker, believe that the introduction of these kits contributed to some of the problems with transvaginal mesh.
Uses and Product Description
Transvaginal mesh is used to treat various health conditions cause by weakened pelvic muscles. The FDA categorizes mesh products into four categories:
- Non-absorbable synthetic. This type of mesh is considered a permanent implant because it will remain in the body indefinitely. More than half of all mesh products approved by the FDA fall into this category. These products are made from synthetic materials like plastic or polyester. Polypropylene is the most popular material for manufacturers, and 91 percent of non-absorbable synthetic mesh is made of this plastic.
- Absorbable synthetic. Absorbable mesh loses strength and degrades over time and is not intended as a long-term treatment. Ideally, the patient’s newtissue growthat the implant site helps to keep the repair strong.
- Biologic. These mesh products are natural and derived from animal tissue that has been specially disinfected for implanting in the human body. These products degrade over time and are usually made from cow (bovine) or pig (porcine) tissue.
- Composite. This mesh is made from a combination of any of the above three categories.
Manufacturers weave synthetic mesh materials together in several different shapes, depending on their intended use. When the fibers are woven together, pores are created on the surface of the material. According to the FDA, lightweight, large-pore mesh reduces the body’s inflammatory response.
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. In fact, three out of four surgeries to treat POP with mesh were done transvaginally in 2010.
Stress Urinary Incontinence (SUI)
Stress urinary incontinence 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 – usually called a bladder sling or vaginal tape – is the most common type of surgery used to correct the condition, and 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.
After a hysterectomy, some women suffer from vaginal vault prolapse – where 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.
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 in the previous six years.
The agency previously reported in 2008 that complications from transvaginal mesh used for surgical treatment of POP were rare, but in 2011 it updated its statement and warned patients and doctors that they are not rare.
Two Serious Complications
Transvaginal Mesh Erosion
Transvaginal mesh erosion occurs when the mesh erodes or passes through the vaginal wall. This causes bleeding, severe pain, infection and nerve damage. When the jagged edges of the mesh erode through tissue and are visible, this is called exposure.
Transvaginal Mesh Organ Perforation
After mesh erodes through the vaginal wall, it can also harm other organs. Organ perforation occurs when the sharp edges of mesh cut into or perforate nearby organs such as the bladder. This can cause serious damage and requires surgery to correct.
|Other complications can include:|
|Pain||Recurrence of prolapse or incontinence|
|Nerve damage||Vaginal scarring|
|Infection||Vaginal shrinkage (scar tissue builds up and “shrinks” the vaginal space, causing pain and discomfort)|
|Painful sexual intercourse||Neuro-muscular problems|
Severe complications like mesh erosion and organ perforation require surgery to fix. This surgery is referred to as revision surgery.
However, because synthetic surgical mesh was designed to stay in the body indefinitely, removal of the mesh is extremely difficult. The blood vessels and tissues grow around the mesh, requiring doctors to remove it in pieces, one surgery at a time.
Linda Gross, who won an $11.11M verdict against Johnson & Johnson, was forced to have 18 revision surgeries. Unfortunately, revision surgery doesn’t guarantee that all symptoms will disappear.
Doctors who specialize in transvaginal mesh revision surgery are called urogynecologists. Urogynecologists receive special training in pelvic floor disorders like prolapse and incontinence and are experienced in performing revision surgeries.
Transvaginal Mesh and the FDA
Compounding the problem is the fact that the FDA did not require transvaginal mesh manufacturers to conduct tests on these products before they were implanted. Also, many of the products on the market today were approved based on the ProtoGen Sling, which was recalled in 1999 after the FDA found the device had a “higher than expected rate of vaginal erosion” and did “not appear to function as intended.”
Urogynecologist L. Lewis Wall wrote in an article in the American Journal of Obstetrics and Gynecology that the ProtoGen “had never been implanted in a human vagina prior to its clearance.” It wasn’t until independent doctors conducted their own clinical trials and studies revealing the risk of complications that the FDA decided to look more closely at transvaginal mesh.
|The FDA’s Activities and Role in Regulating Transvaginal Mesh|
|October 2008 – FDA releases Public Health Safety Notification warning the public about omplications of transvaginal mesh for SUI and POP, but says complications are rare.|
|July 2011 – FDA updates its 2008 Public Health Safety Notification to say that complications are not rare. It also states that “it is not clear that transvaginal POP repair with mesh is more effective” than non-mesh repair and “may expose patients to greater risk.”|
|September 2011 – FDA organizes the Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee.|
|January 2012 – Based on recommendations of the panel, the FDA orders manufacturers of transvaginal mesh products to conduct postmarket studies.|
|February 2012 – FDA issues 95 postmarket study orders to 34 manufacturers of POP mesh products and 14 orders to 7 manufacturers of SUI mesh.|
|March 2013 – FDA updates its Web page to include more information on adverse events and mesh used for SUI.|
Lawsuits, Verdicts and Settlements
Tens of thousands of women and their families filed lawsuits against the major mesh manufacturers after being injured by transvaginal mesh. Chief Judge Joseph R. Goodwin is overseeing six federal multidistrict litigations (MDLs) in the Southern District of West Virginia.
|The companies involved in the MDLs include:|
|C.R. Bard||Ethicon Inc. (Johnson & Johnson)|
|American Medical Systems||Coloplast Corp|
|Boston Scientific Corp.||Cook Medical Inc.|
Christine Scott and her husband won a jury verdict of $5.5 million against C.R. Bard in 2012, and then in 2013, a jury ordered Ethicon to pay $11.11 million to Linda Gross for her injuries.
In June 2013, American Medical Systems’ parent company, Endo Health Solutions, agreed to pay $54 million to settle an undisclosed number of mesh lawsuits.
Laura Yaeger, an attorney who has extensive experience with transvaginal mesh lawsuits, told Drugwatch that more than 40 mesh products are involved in the federal lawsuits. Judge Goodwin set trial dates for each defendant, beginning in July 2013 with Bard.