Stopping Medical Malpractice: FDA Bans Pelvic Mesh for Women

Published on May 2nd, 2019

medical malpractice fda bans vaginal mesh thurswell lawMillions of women have undergone a procedure to have synthetic vaginal mesh implanted to prevent the sagging of the bladder, uterus, and other organs into the vaginal area, also known as pelvic organ prolapse or pelvic floor disorder. Now, the Food and Drug Administration (FDA) has halted the sale and distribution of what they consider ineffective pelvic mesh in the United States, citing safety risks to women.

Understanding Pelvic Floor Disorder

Both men and women have a pelvic floor but, for women especially, the pelvic floor does not always work as well as it should. This can be chalked up to carrying an infant, giving birth, and all the strain that can come along with these acts.

In a woman, the pelvic floor is comprised of muscles, connective tissues, ligaments, and nerves that support the uterus, vagina, rectum, and bladder. When the “sling” that supports the pelvic organs is damaged or weakened, a pelvic floor disorder results and can cause urinary problems, fecal incontinence or constipation, and pelvic organ prolapse.

For some pelvic floor disorders, nonsurgical treatments can improve the dysfunction. Doctors may recommend making behavioral changes, increasing liquid intake, doing yoga, taking muscle relaxants, or undergoing physical therapy to learn how to relax and coordinate the movement of pelvic floor muscles.

When a noninvasive solution is not enough to address the problem – which is usually the case with pelvic organ prolapse – surgical intervention is often necessary. Unfortunately, for some women, a surgery that is meant to help their condition can create even greater complications.

The Dangers of Pelvic Mesh for Women

The repair of pelvic organ prolapse has been done using surgical mesh since the 1970s. In the 1990s, doctors began using vaginal mesh for transvaginal repair of the prolapse. The mesh is implanted in the vaginal wall, but it does not come without complications. Reported problems have included bleeding, inflammation, pain, and even the protrusion of the mesh through the wall, leading to infection. A second surgery is often necessary for many women to repair the damage caused by the mesh.

There have been lengthy legal and medical battles surrounding vaginal mesh for years. The FDA’s ban on certain surgical mesh products has the manufacturers crying foul, saying many will suffer because of now limited treatment options. Those who oppose the mesh say there was never a need for the product because there is an alternative surgical procedure that can be done using the patient’s own tissues.

The FDA Bans Transvaginal Mesh

The FDA previously categorized the transvaginal mesh as high-risk and now say that the manufacturers have not provided enough evidence to prove otherwise, leading to their decision to halt the sale of the product.

Even the smallest mesh devices have a high complication rate and, ultimately, any woman who has developed more health problems because of a transvaginal mesh surgery has had her quality of life dramatically affected.

More than 100,000 women who have had complications like sever plain and bleeding from vaginal mesh implants have filed medical malpractice claims against medical device manufacturers like Johnson & Johnson and Boston Scientific, totaling close to $8 billion.

Have you suffered because of a botched medical procedure or poorly manufactured medical tool? Get help from the personal injury lawyers at Thurswell Law. Schedule a consultation by calling (248) 354-2222 today. We do not charge any fees unless you collect.

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