TransVaginal Mesh (or TVM) is a product composed of a plastic substance (polypropylene), which is then implanted into a woman to act as a retaining wall or hammock, holding the pelvic organs in place and to help treat urinary problems. This procedure was intended to be a cost-effective and less dangerous alternative to reconstructive surgery. During this procedure, mesh is implanted through the vagina (TransVaginally) as this procedure is less intrusive than going through the woman’s abdomen and recovery time is much quicker to reach the affected areas.
The use of TransVaginal mesh promised to treat several female conditions such as Stress Urinary Incontinence, Pelvic Organ Prolapse, Uterine Prolapse, Bladder Prolapse, Rectal Prolapse, Vaginal Vault Prolapse and Small Bowel Prolapse.
This medical device is designed to treat a female patient’s medical condition known as “pelvic organ prolapse” (POP) which a painful medical condition resulting from the falling of a woman’s internal organs to her pelvic floor and into her vagina. The falling of a woman’s internal organs typically results from menopause, child birth or a hysterectomy due to a woman’s pelvic muscles weakening and the organs around the pelvic area – including the uterus, bladder, and rectum – dropping into the woman’s vagina.
Besides the pain, the “pelvic organ prolapse” often results in urinary incontinence for the woman formally known as “stress urinary incontinence.” The TransVaginal Mesh is designed to support the woman’s internal organs and when the device is used to treat the resulting urinary incontinence, it is known as a “bladder sling.” The mesh is designed to support the woman’s urethra when the pelvic muscles are weak and to prevent bladder leak caused by increased pressure on the bladder resulting from physical exertion such as running and exercising.
The vast majority of surgeries concerning “pelvic organ prolapse” and “stress urinary incontinence” are typically performed transvaginally because such a procedure is less intrusive than going through the woman’s abdomen and recovery time is much quicker.
Unfortunately, in recent years a number of problems with TransVaginal Mesh have emerged. As a result, the Food and Drug Administration (FDA) has issued public health warnings, and thousands of injured women have filed lawsuits.
Surgical mesh has been used for internal repairs since the 1950sand was originally developed to support the abdominal wall in the repair of hernias. By the 1970s, gynecologists began to believe that mesh had a use in the repair of Pelvic Organ Prolapse (POP), and by the 1990s, surgical mesh was being used to do TransVaginal repairs of POP and to treat Stress Urinary Incontinence (SUI).
While surgical mesh has had a 50-year evolution in its uses for a variety of repairs, the TransVaginal Mesh has been more recent, with approval for this purpose by the FDA only coming in 2002. In subsequent years, the FDA has approved a number of different mesh systems for TransVaginal use as well.
When the FDA initially approved TransVaginal Mesh, it claimed that complications were rare, however, in recent years the number of reported cases of complications has increased dramatically. With the continued publicity of problems due to the procedure, and the large number of women involved, they are likely to continue to do so.
According to a statement issued by the FDA in July of this year, about 1,500 complaints of complications and 7 deaths were reported between 2008 and 2010, five times as many as in 2005 to 2007. Follow-up investigation revealed that three of those deaths were related to TransVaginal Mesh. Potential complications include infection, hemorrhage, painful sexual intercourse, recurrence of POP and urinary incontinence, and mesh erosion of the vaginal epithelium.
In 2010, at least 100,000 POP repairs used surgical mesh, and about 75,000 of these were TransVaginal procedures. POP may develop in 30% to 50% of all women in their lifetime, with 2% developing symptoms. While there does appear to be a potential for serious complications, including death, according to the same FDA statement, there was no real evidence that the mesh was any more effective than the traditional non-mesh surgical repair, or colporrhaphy.
The financial impact of lawsuits against the manufacturers of TransVaginal Mesh will be tremendous. Once the mesh is implanted it is extremely difficult if not impossible to remove and some patients may suffer with complications for the rest of their lives.
One clue to the number of potential lawsuits-in-the-making can be found in an article in the journal Obstetrics & Gynecology which noted that as many as 15% of all women who have received the mesh implant will experience erosion, a potentially serious complication resulting in pain and infection. That represents a very large number of women who may be going after the manufacturers of TransVaginal Mesh for damages. The total impact is unknown, but one may confidently assume that it will be devastating, both to the women who must live with the consequences of an unsafe product, and to the companies that manufactured and marketed it.