Earlier this month, a jury in the Southern District of West Virginia awarded $3.25 million to a woman who was implanted with the Gynecare TVT OBturator, or TVT-O, pelvic mesh (or transvaginal mesh) device, according to Reuters. The jury found that Johnson & Johnson’s Ethicon, Inc. unit was liable for selling a defective product, and for failing to warn patients and doctors about the risks associated with the device. The 52-year-old woman who received the TVT-O implant and brought the suit had to endure multiple surgeries to correct the damage she received as a result of TVT-O. Her injuries include continual chronic pelvic pain, despite procedures to remove the mesh.
Ethicon is not the only company in hot water over the transvaginal mesh products. Other companies such as C.R. Bard Inc. are contending with similar litigation. In fact, last year, a jury slapped C.R. Bard with a $2 million verdict in federal court.
What exactly is transvaginal mesh? Transvaginal mesh is usually made of plastic called polypropylene, and is implanted usually through the vagina to permanently fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs (including the bladder, rectum and uterus), drop into the vagina. This condition typically plagues women after a hysterectomy, menopause or childbirth. Obesity may also cause POP. When POP occurs, women typically suffer pelvic pain, urinary incontinence, and discomfort. Some women have even experienced complications as serious as infection, erosion of the vaginal tissues and organ perforation as a result of these products. According to the U.S. Food and Drug Administration, erosion of mesh through the vagina is the most common and consistently reported complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. However, sometimes even multiple surgeries do not eradicate the pain or remove the mesh completely.
In years prior, the FDA has issued multiple advisory safety communications regarding transvaginal mesh. In fact, in 2011, the FDA advised health professionals to recognize that in most cases, POP can be treated successfully without mesh. Therefore, by considering alternative treatments, patients can avoid the risk of mesh-related complications. Earlier this year, the FDA indicated that it was considering proposals to tighten safety standards for transvaginal mesh devices used to treat pelvic organ prolapse. If finalized, manufacturers would be required to submit data proving the devices’ safety and effectiveness before being allowed to sell them.
If you have received transvaginal mesh to treat pelvic organ prolapse, stress urinary incontinence or any other pelvic disorder and have suffered any of the above complications as a result, you may be able to hold the manufacturer of that product liable. Contact Brooks Law to determine whether you are entitled to any compensation as a result of injury and damages caused by their defective product.