Pharmaceutical

Georgia woman sues three manufacturers over transvaginal mesh injuries

Gavel Scales of Justice American flag square Georgia woman sues three manufacturers over transvaginal mesh injuriesA Georgia woman has filed a lawsuit against three manufacturers of transvaginal mesh products over severe injuries she alleges were caused by propylene mesh devices she had implanted in April 2006.

According to the lawsuit, the plaintiff suffered from pelvic organ prolapse (POP) and stress urinary incontinence (SUI), conditions usually brought about by childbirth and age and characterized by weakened pelvic muscles, which can affect the position and function of the bladder, uterus, intestines, and other pelvic organs. The plaintiff’s physician corrected these problems by implanting a Gynecare Prolift Total Pelvic Floor Repair System made by Johnson & Johnson, a Uretex Sup Pubourethral Sling made by C.R. Bard, and Polyform Synthetic Mesh made by Boston Scientific.

However, instead of improving her health and overall quality of life, these transvaginal mesh products allegedly caused the plaintiff to experience devastating physical and mental pain and suffering, permanent injury, substantial and permanent physical deformity, and the loss of her bodily organ system, and other complications.

In July 2011, a U.S. Food and Drug Administration (FDA) report found a fivefold increase in the number of deaths, injuries, and malfunctions linked to transvaginal mesh devices. The agency then ordered 33 manufacturers of the mesh products to conduct three years of safety and efficacy trials – testing that wasn’t conducted before the FDA granted them approval through its 510k fast-track process.

However, thorough post-market evaluation of transvaginal mesh safety won’t do much good to the approximately 300,000 U.S. women who have already had the devices implanted. Transvaginal mesh products have worked as intended for many women, but for many others, the devices have been linked to crippling pain and injury.

Transvaginal mesh devices can shift from their intended position, break apart, and erode through the vaginal wall, which may result in intense pain and a range of complications including organ perforation, major bleeding events, and infection. Complications can be so severe that they result in an inability to work or engage in sexual intercourse.

Unfortunately, because transvaginal mesh is designed to meld with surrounding muscle and tissue, removing it may require multiple surgeries. In some cases, the mesh device can’t be completely removed, leaving patients to face a lifetime of chronic pain.

Sources:

PR Web
Bloomberg/BusinessWeek