FDA Requires New Safety Study, Prompting Texas Vaginal Mesh Lawsuits

January 5, 2012 — If you have suffered a complication caused by vaginal mesh, you may have a Texas vaginal mesh lawsuit. After receiving numerous reports of serious complications, the Food and Drug Administration (FDA) is requiring the manufacturers of vaginal mesh, transvaginal mesh, and other surgical mesh products to conduct an emergency safety study.

The FDA-mandated emergency safety studies will likely take several years to complete. The companies will need to design a study that meets the FDA standards, and then track women who have received the surgical mesh over three years. The FDA sent letters to Johnson & Johnson, C.R. Bard Inc., and 31 other manufacturers of these devices. These manufacturers are now facing more than 650 vaginal mesh lawsuits from consumers who experienced death, injuries, or malfunction with the products.

There has been growing concern over the safety of these products. In 2008, the FDA issued a safety warning to consumers because it had received reports of complications, but it said that these were rare. Between 2008 and 2010, the number of reports increased five-fold. The number of vaginal mesh lawsuits brought by injured people has also increased.

Under the FDA’s 510(k) program, certain medical products — including vaginal mesh and surgical mesh — do not have to be tested on humans before they reach the market. Furthermore, once they are on the market, manufacturers to not need to track the people who receive these devices to study complications. There has been an outcry among consumers who want such devices tested more thoroughly before reaching consumers. Many of these people are now filing a Texas vaginal mesh lawsuit.

Hundreds of thousands of women have received these implants, and an estimated 15% have had complications, according to a study in the journal Obstetrics and Gynecology. The study also found that vaginal mesh surgery was no more effective at preventing incontinence than traditional techniques, in which ligaments in the patient’s body are used to strengthen weakened muscles.

Complications include organ damage, caused by edges of the mesh cutting into internal organs. The procedure is also prone to high rates of infection, because it is implanted through the vagina, which is not a sterile environment. An advisory panel recommended in September that the products be reclassified as “high risk” devices that require human testing before they can be implanted in hundreds of thousands of people.

What is vaginal mesh? It is a medical device implanted in women who suffer from female incontinence, caused by a weakening of the muscles in a woman’s abdomen (called pelvic organ prolapse). When these muscles weaken, organs can sag downward, putting pressure on the bladder. The muscles may also be too weak to control urine. Vaginal mesh works by making a “hammock” that supports these internal organs.

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