Transvaginal Mesh Injury Attorney Killeen
Transvaginal mesh devices were introduced in the 1990’s as a way to permanently repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Both of these conditions are the result of weak or damaged vaginal walls and usually arise in older women, typically after they have had a hysterectomy or have experienced menopause. They can also occur as a result of pregnancy or child birth.
- Pelvic organ prolapse (POP) – the mesh is used to treat a condition whereby the organs in the lower abdomen can slip out of place. This happens as a result of weak or damaged vaginal walls that allow the bladder, rectum or uterus to drop into the vaginal cavity.
- Stress urinary incontinence (SUI) – the mesh is used to support or reduce pressure on the bladder that can cause complications in control of the urination process. This happens when everyday activities such as laughing, coughing or sneezing place pressure on the bladder and lead to urinary incontinence or leaking of urine.
While the surgical mesh has been used extensively in hernia repairs, it was never tested for vaginal repairs. In fact, it was approved under a fast track approval system known as a 510(k) which doesn’t require the manufacturers to test their products or devices as long as they are similar to an already approved product or device on the market.
For a free legal consultation with a transvaginal mesh injury lawyer serving Killeen, call 800-863-5312
But this fast track approval did not bode well for women. In 2008, the Food and Drug Administration (FDA) issued a public health advisory warning of serious complications related to transvaginal mesh devices, but claimed that complications were rare. Over the next three years, the FDA received more than 1,000 reports of complications from surgical mesh manufacturers so they updated their advisory and noted that complications were not that rare after all.
The FDA also ordered all of the manufacturers to conduct post-market safety studies. The largest makers of transvaginal mesh products include American Medical Systems, C.R. Bard, Boston Scientific, and Johnson & Johnson.
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