If you are a patient seeking treatment for pelvic organ prolapse—or have already received treatment—then beware. In July of last year, the FDA issued new safety information on the use of transvaginal mesh implants that should make patients and physicians think twice before pursuing that treatment option.
Pelvic organ prolapse is a medical condition that many women experience, although to varying degrees of severity. It occurs when one of the pelvic organs—most commonly the bladder—drops from its normal positioning and pushes against the walls of the vagina. The prolapse happens because the pelvic muscles become weakened, perhaps from childbirth or from surgery. Depending on the severity, pelvic organ prolapse can be very uncomfortable or painful, leading a patient to seek treatment.
One of the treatment options available is surgery to repair the weakened muscle tissue and this is where the risks of transvaginal mesh implants are relevant. To repair the tissue, one common practice has been to use a mesh implant. In 2010 alone, there were at least 100,000 surgeries that used surgical mesh implants. But now the FDA is saying that the use of these mesh implants “may expose patients to greater risk than other surgical options” and that there is “no evidence of greater clinical benefit.” This is a big warning sign to patients who seek surgical treatment for pelvic organ prolapse.
Concern over this procedure started building in 2008 and since then, reports of adverse outcomes have flooded into the FDA. Between 2008 and 2010, the FDA received 1,503 adverse event reports, five times the amount received in the prior two year period. The adverse consequences reported range from the mesh becoming exposed out of the vaginal tissue, pain, infection, bleeding, pain during sexual intercourse, organ perforation during the surgical procedure, and urinary problems. The solution has often been additional surgeries and hospitalization.
In the wake of all of this information, lawsuits over the use of transvaginal mesh are starting a steady flow into the court system. If you are one of thousands of women who suffered because of the use of transvaginal mesh to treat your pelvic organ prolapse, the attorneys at Inserra & Kelley are prepared to hear about your situation.
A partner with Inserra & Kelley, Attorneys At Law since 1993, Craig Kelley focuses on personal injury law with a large emphasis on motorcycle and bicycle related cases and claims with the goal of first helping clients heal and then getting speedy resolution of their disputes.