Introduced in the 1990s, transvaginal mesh was intended to permanently fix pelvic organ prolapse (POP) and stress urinary incontinence — conditions that typically plague older women after a hysterectomy or menopause. Pelvic prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs — including the bladder, rectum and uterus — drop into the vagina. SUI occurs when everyday activities place pressure on the bladder.
To fix these conditions, a hammock-like piece of synthetic mesh is surgically implanted transvaginally, or through the vagina, to support the pelvic organs.
However, transvaginal mesh has several well-known complications such as organ perforation and erosion. Some of the less severe problems include constipation and urinary incontinence.
In 2008, the FDA issued a public health notification revealing the serious complications of transvaginal mesh, but said the occurrences were rare. Three years later, in 2011, the FDA updated its advisory to say that serious complications from vaginal mesh repair were not rare, and later ordered mesh manufacturers to conduct post-market safety studies.
Adding to the problem is the fact that this mesh — which has been successfully used to repair hernias for years — was never tested for vaginal repairs. The FDA’s fast-track approval system, called the 510(k), doesn’t require testing prior to market release as long as the product is similar to an already-approved product.
Transvaginal Mesh Can Cause Severe & Painful Complications
A common problem associated with vaginal mesh implants is unfortunately quite dangerous. Transvaginal mesh erosion, also called mesh extrusion, occurs when the rough edges of the synthetic mesh cut through the vaginal lining and nearby organs.
This can cause organ perforation, infection, bleeding, pain during intercourse and urinary problems. The FDA noted that there are also reports of recurrent prolapses, neuromuscular problems, vaginal scarring and emotional problems as a result of the mesh.
After reviewing published scientific research from 1996 to 2011, the FDA also found that mesh repairs of pelvic prolapse may not fix the symptoms of prolapse or improve the patient’s quality of life more effectively than non-mesh repairs.
In particular, the FDA discovered several alarming facts:
- Transvaginal mesh repairs introduce more risks than traditional non-mesh repairs.
- There is no evidence that mesh used for repairs on the top or back wall of the vagina provide any added benefits compared with traditional surgeries without mesh.
The FDA also found that the mesh often contracts, or shrinks, once inside the patient. This can cause vaginal shortening, tightening and pain. Both erosion and contraction can lead to severe pelvic pain, pain during intercourse or a complete inability to engage in intercourse. Men may also experience pain and irritation to the penis when exposed to the mesh.
Multiple Revision Surgeries Often Required to Correct Problems
With more than 75,000 transvaginal mesh prolapse surgeries performed in 2010 alone, and more than 10 percent of them resulting in failure, it’s no wonder an increasing number of women are having problems with mesh. Many turn to urogynecologists, who are specialists in this area. Medical experts say that complications with vaginal mesh may be inevitable — if they don’t happen right away, they could within a couple years after placement.
A surgical revision, or surgical removal, of the transvaginal mesh device is often painful and difficult because tissues grow in and around the mesh. Revision surgery is also costly and dangerous, with lengthy recovery periods and a high risk of further damage or infection.
Because it is difficult to effectively remove the mesh, revision surgery is often performed several times before all the mesh pieces have been removed.
FDA Reviews Vaginal Mesh Safety but Declines to Recall
The first transvaginal mesh recall dates back to the 1990s when Boston Scientific Corp. pulled its ProteGen mesh device from the market amid safety concerns. In 2003, Boston Scientific quietly settled nearly 1,000 lawsuits over its mesh. In 2006, Mentor Worldwide removed its ObTape mesh from the market after numerous reports of problems.
In September 2011, the FDA’s Obstetrics & Gynecology Devices Advisory Committee reviewed the dangers of mesh and the associated health risks. Despite pleas from consumer advocates, the 15-member panel declined to remove transvaginal mesh from the market. However, the committee did call for more stringent testing of new mesh devices and also supported reclassifying the device as Class III. This would require premarket approval to ensure the safety and effectiveness of any future devices.
In January 2012, the FDA sent letters to dozens of transvaginal mesh manufacturers, requiring three-year studies to be performed on their products. The goal is to study the device’s side effects and the women’s overall quality of life.
In July 2012, Johnson & Johnson stopped selling four mesh products: Gynecare TVT Secur system, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift + M. C.R. Bard also pulled its Avaulta line of mesh products from the market.
Thousands File Transvaginal Mesh Lawsuits
For the thousands of women who have already suffered the effects of improperly placed mesh, the diminished quality of life is undeniable. So far, thousands of cases have been consolidated into multidistrict litigation (MDL) in the U.S. District Court of West Virginia. The five companies involved are American Medical Systems, Boston Scientific Corp., Johnson & Johnson’s Ethicon, C.R. Bard and Coloplast. The transvaginal mesh lawsuits allege that various models of the mesh share similar design flaws and risks.
The cases were centralized into MDLs because they all contain similar sets of facts and injuries. This process avoids conflicting court rulings that can come from judges in different jurisdictions, and also keeps court costs down. Judge Joseph R. Goodwin, who was already handling the C.R. Bard MDL, is now handling the five mesh MDLs.
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