Bladder Sling Recall
Recently, the first major bladder sling recall was announced by a major mesh manufacturer. Hundreds of vaginal mesh lawsuit claims were filed against various mesh manufacturers after the FDA issued an alert in July 2011 about the medical devices.
The high risk of transvaginal mesh complications first attracted widespread attention in 2008. Although there were reports of problems, it wasn’t until that year that the Food and Drug Administration issued a formal public health notification about them. Prior to its announcement, the agency had received over 1,000 reports of health issues suffered by women as a result of their vaginal mesh surgeries.
In 2011, a second warning was announced. The FDA disclosed that pelvic mesh complications, such as vaginal pain and recurring infections, were “not rare.” It also revealed that transvaginal placement of the devices was associated with serious problems not previously reported. One example was mesh contraction, an issue that can cause severe pelvic pain. There have since been over 650 vaginal mesh lawsuit claims filed across the U.S. Many more women are expected to come forward in order to seek recourse for their injuries.
Reasons Transvaginal Mesh Is Implanted
Mesh has been used for a few applications since the 1950s. It was first implanted to correct abdominal hernias. This is still done today though the surgical techniques and devices used have undergone significant changes.
Gynecologists began implanting surgical mesh to treat pelvic organ prolapse (POP) in the 1970s. POP occurs when the pelvic muscles and ligaments weaken to the point that they can no longer support the organs in the pelvis. The bladder, rectum, uterus, or small bowel fall and press against the wall of the vagina.
Mesh devices were first used to repair stress urinary incontinence (SUI) in the 1990s. SUI occurs when the muscles that control the flow of urine from the bladder weaken. This causes involuntary urine leaks.
Back then, surgeons took mesh designed for hernias, and cut them into shapes that would fit the anatomies of their patients’ pelvises. The devices were installed through incisions made into the abdomen. The FDA cleared the first SUI-only surgical mesh in 1996. It cleared the first POP-only device in 2002. It was after that point that manufacturers began designing kits in earnest to support the transvaginal placement of mesh for POP and SUI.
Complications Prompt A Surge In Bladder Sling Lawsuits
Between January 1, 2005 and December 31, 2010, the FDA received 3,979 reports of complications. The number is likely much higher today, especially given the FDA’s 2011 safety warning. Women who have undergone transvaginal mesh surgery for POP and SUI have complained about numerous problems that developed after their operations.
For example, most have experienced some degree of vaginal or pelvic pain. It may present primarily during sexual intercourse (known as dyspareunia), or persist throughout each day. Many women have also suffered from a problem called mesh erosion; the device begins to move through the vaginal tissue, causing severe pain. In many cases, it surfaces in the vaginal canal and causes pain for the woman’s sexual partners.
Recurrent urinary tract infections, vaginal scarring, and even neuromuscular disorders have been reported to the FDA. Additionally, as noted earlier, some women have experienced mesh contraction, a problem in which the device shrinks following implantation. It has been linked to vaginal shortening and severe pain.
How Many Women Are Affected By Surgical Mesh Complications?
The precise number of women affected by transvaginal mesh complications is unknown. Many have undergone surgery to have mesh implanted through the vaginal wall, and not yet experienced problems. But erosion, contraction, and other issues may occur years down the road.
To place the scope of the issue in context, the FDA reported that 75,000 women underwent vaginal mesh surgery to repair pelvic organ prolapse in 2010. An additional 208,000 women underwent similar procedures to repair stress urinary incontinence during the same year. There is a substantial level of exposure, although failure rates for each device currently for sale have not been published.
These problems are sufficiently widespread to have spurred the FDA to consider reclassifying transvaginal mesh as a Class III medical device (it is currently a Class II device). This classification would require manufacturers to submit their devices to clinical testing prior to being cleared for sale.
If you underwent transvaginal placement of surgical mesh, and have suffered from vaginal bleeding, infection, pain, and other side effects, you may be eligible to file a claim for compensation. Contact an experienced vaginal mesh lawsuit lawyer to discuss your case and for the latest bladder sling recall updates.