If you had a transvaginal mesh, or a pelvic mesh procedure for stress urinary incontinence (SUI) or pelvic organ prolapse (POP), you are among many women who have been subjected to a defective product. Need proof? Here we’ll explain the up-to-date facts, figures, and overall impact of transvaginal mesh on women across the country.
Transvaginal Mesh Facts
Transvaginal mesh is a synthetic net-like device (some say it looks like a window screen) that is implanted in women to treat stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). The screen-like product is made of polypropylene, a substance that was created to patch hernias, which is a very small area. Manufacturers took this product and made a large sling that was then put into a woman’s vagina prior to any testing in the vaginal area.
Stress urinary incontinence is the inability to hold urine while living out typical daily life that includes movement like bending or lifting, or through stress created by pelvic organ prolapse. POP affects millions of women—it is more common than you think. Almost 20% of women will undergo surgery for prolapse or incontinence in their lifetimes, and for many women, that means being exposed to the nightmare effects of transvaginal mesh (TVM).
Up until the first transvaginal mesh product approval in 1996, SUI and POP were treated with more complex surgeries that required more work for doctors, but resulted in more healthy patients long term.. TVM became the ‘gold standard’ for treating SUI and POP without a lot of evidence of its comparative safety or efficiency for this purpose.
Transvaginal Mesh Figures
The FDA has a complicated history with transvaginal mesh. In 1996, the FDA approved the first mesh product. After this initial approval, all bladder mesh products that applied for approval after 1996 were cleared to go to marked based on the fact that they were similar to the Boston ProtoGen Sling—even though it was recalled!
The FDA issued several warnings about the safety and efficiency of mesh, upgrading the warning with each release. As of 2014, FDA named transvaginal mesh a class III high-risk device warning of its common and extreme side effects.
Settlements began in 2012 with a case brought by victim Christine Scott against manufacturer C.R. Bard. Scott was awarded $5.5 million for her injuries. Since then, millions of dollars have been awarded to thousands of patients across the country and the world. Today, in 2017, transvaginal mesh is known as the one of the largest groups of cases in U.S. history.
And it’s clear that mesh settlements are not slowing down. On the contrary, they are heating up.
The most recent big win was announced March 7, 2017 by a California judge against Caldera Medical. The judge ordered the company to pay $12.5 million to settle 2,700 cases consolidated in California. This sets the tone for a solid year in transvaginal mesh settlements for victims.