Transvaginal Mesh Lawsuit
What is a Transvaginal Mesh?
A transvaginal mesh is a synthetic sling-based support used to strengthen pelvic floor muscles. Pelvic muscle weakening is a common phenomenon experienced by women as a result of childbirth or aging. It results in the bladder or uterus bulging and descending, applying pressure onto the vaginal wall and causing severe pain and discomfort. This weakening can also result in conditions such as Stress Urinary Incontinence (SUI) or pelvic organ prolapse (POP). Stress Urinary Incontinence involves the person being unable to maintain control over bladder movements in response to even simple physical movements like coughing or sneezing. Needless to say, these can severely affect the lifestyle of the individual.
These meshes arose from those used in hernia repair in the 50’s. They were formally introduced for public use in the 90’s by the FDA, which fast-tracked the procedure based on the initial promise in the results. Over the next two decades, hundreds of thousands of women underwent the procedure and were able to restore some balance to their health.
However, these benefits were short-lived, and a large number of women began to experience complications due to the procedure. These included, but were not limited to:
- excessive, ongoing vaginal discharge and drainage
- vaginal scarring and shortening
- skin breakage
- contraction of the mesh sling
- vaginal bleeding
- protrusion of the device
- erosion of vaginal epithelium
- vaginal shrinkage
Soon, these transvaginal meshes became the center of many a transvaginal mesh lawsuit targeting the manufacturers for using little or no evaluation methods to test the safety of their products. The FDA initially issued a public health notice in 2008 in response to the complaints received from across the United States. In this notice, the FDA stated that health complications from these meshes were rare and not a cause for concern. However, in 2011, the FDA issued a more comprehensive notice in which it acknowledged that these complications could occur more frequently than previously expected. At the same time, an order was issued to manufacturers to carry out post-market safety testing.
While a thorough investigation into the matter is ongoing, many legal firms are gathering evidence and filing transvaginal mesh lawsuits against manufacturers. Prominent names in these cases are Johnson and Johnson and C.R. Bard Inc.
Products such as C.R. Bard’s Avaluta Plus have been the focus of a particular transvaginal mesh lawsuit, in which the plaintiff claimed to have experienced internal bleeding and had to undergo multiple surgeries to remove the mesh. According to the attorneys, the material used to develop the transvaginal mesh was deemed unsafe for human use, but the executives at the company allegedly ignored the information. The first trial ended in a mistrial, but a second trial has recently begun and the results are being awaited.
There have been instances where a transvaginal mesh lawsuit has resulted in success. In February this year, a woman in South Dakota was awarded $3.35 million in a case against Johnson and Johnson. The court ruled that the company did not adequately inform doctors of the risks associated with the use of these implants, causing patients to be misled.
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