Transvaginal mesh (TVM) is a surgical mesh product that came into common use in the late 2000s in an effort to treat a variety of female health problems. Transvaginal mesh was most commonly used for pelvic organ prolapse (POP) and for the treatment of stress urinary incontinence (SUI). It was widely marketed by several different manufacturers and used throughout the world.
Unfortunately, it soon became clear that transvaginal mesh was causing serious health problems for many women. In addition to causing significant pain and discomfort, the problems related to transvaginal mesh often necessitated an additional surgery and could sometimes be deadly.
Information about Transvaginal Mesh
For many women, especially those who have had children, the pelvic muscles begin to weaken as they age. In some cases, this can cause health problems such as stress urinary incontinence where it becomes difficult to control the flow of urine. Women suffering from stress urinary incontinence generally have a weakening in the muscles that support the urethra or bladder and may urinate involuntarily when they sneeze, laugh or engage in other physical activities.
Another common condition in women, especially after childbirth, is pelvic organ prolapse. This occurs when the organs in the pelvis are no longer properly supported and begin to drop or protrude out of their normal location. The organs, including the uterus, the bladder, the small bowel and the urethra, can start to press on the vagina when they begin to drop. This can be painful and uncomfortable.
Treatment of either SUI or POP can be accomplished by using a surgical mesh to create a sling that holds the organs in place and provides support for the muscles.
The use of transvaginal mesh began in the late-2000s when many manufacturers, including Ethicon (a subsidiary of Johnson & Johnson), came to the market with transvaginal mesh products. In 2010, an estimated 300,000 women in the United States had a synthetic mesh implant.
Many of the transvaginal mesh products that became so popular were released under special rules by the Food and Drug Administration (FDA). The FDA is intended to oversee medical devices and drugs that are released onto the market and normally has a rigorous standard before medical devices are approved that includes extensive medical testing.
However, the FDA has a program called the 510(k) program, which sets up special rules. The 510(k) program says that if a device is substantially similar to another medical device already on the market, then it can be fast-tracked for approval. Transvaginal mesh products were able to obtain fast-tracked approval under 510(k) rules.
Unfortunately, these 510(k) rules create a lot of problems because often they allow potentially unsafe products to get approved without sufficient testing or oversight. In particular, there is concern that when a device is voluntarily recalled (as opposed to being subject to a mandatory recall), other substantially similar — and likely equally dangerous — devices could still receive fast-tracked approval under 510(k) rules.
Transvaginal Mesh Complications
There are numerous potential side-effects, complications and problems associated with transvaginal mesh devices. Some of the potential complications include:
Many women may also experience a recurrence of their organ prolapse. In other words, the mesh does not do what it is supposed to, and the patient will need to undergo additional surgery. One surgery may not be enough to correct all of the problems caused by the mesh, and some women have to undergo multiple painful, invasive and expensive medical procedures.
Transvaginal mesh began causing these serious complications and problems almost immediately after it became a common treatment method. By October 2008, the FDA indicated it had already received in excess of 1,000 complaints of adverse complications caused by transvaginal mesh. The FDA issued a warning at this time indicating that there were complications but that the complications were rare.
It turned out that TVM complications actually were not rare at all. From January 1, 2008, through December 31, 2010, the FDA received an estimated 2,874 new complaints about transvaginal mesh products. The complaints came from 1,503 women who had undergone procedures using transvaginal mesh to treat pelvic organ prolapse and from 1,371 women who had undergone treatment for stress urinary incontinence.
The FDA conducted a detailed review of literature published in the scientific and medical communities between 1996 and 2011. The review revealed unacceptable risks of side effects and that there was no perceivable benefit or improvement in quality of life or outcome when using transvaginal mesh as compared to other traditional methods of treating pelvic organ prolapse or stress urinary incontinence.
Based on this information, the FDA updated its warning in 2011. The new warning indicates that transvaginal mesh can expose patients to significant risk and that the complications are not rare. In January 2012, the FDA ordered 33 manufacturers of transvaginal mesh products to conduct extensive studies related to the safety of their products.
Suffering from TVM Complications? Talk to Our Defective Medical Device Lawyers
The defective medical device lawyers at Roberts & Roberts are currently reviewing claims from women who have suffered complications from transvaginal mesh implants.
For a confidential, no-cost claim evaluation, contact the product liability lawyers at Roberts & Roberts today at 903-597-6000 or contact us online. The call costs you nothing… It could mean everything.