On 7/13/2011, the U.S. Food and Drug Administration released a warning addressed to health care professionals as well as the general public regarding the risks associated with the use of transvaginal mesh, like Johnson & Johnson’s Gynecare TVT, for the treatment of Pelvic Organ Prolapse. The FDA’s official statement made clear that the potential negative consequences of using vaginal mesh are “not rare” and urged doctors to fully consider all other available treatment options before choosing a TVT system like Gynecare. This warning was issued after repeated complaints of adverse effects were reported to the FDA, prompting further investigation.
Gynecare TVT is one of many transvaginal mesh products made and distributed by Johnson & Johnson’s subsidiary Ethicon. Transvaginal mesh, like Gynecare, is a surgical device used for the treatment of Pelvic Organ Prolapse, a condition that occurs in women, most frequently following childbirth or other surgical procedures. POP causes various pelvic organs to shift downwards and apply pressure onto the vaginal walls. In order to combat this, Johnson & Johnson’s Gynecare TVT provides additional support for pelvic organs, most commonly the bladder/urethra, and impedes the onset of further complications. Unfortunately, mesh inserted transvaginally, like Gynecare, has been linked to the onset of a whole new set of debilitating and painful medical complications.
Although the intention of Johnson & Johnson’s Gynecare was to permanently treat Pelvic Organ Prolapse, it has unfortunately been linked to severe medical complications. The most common problem associated with Gynecare TVT use is called “mesh erosion,” and it occurs when the TVT forces its way through the sensitive walls of the vagina. The occurrence of mesh erosion is highly painful, and often requires further surgery in order to fully remove the mesh. Symptoms of Gynecare TVT complications include, but are not limited to:
When the use of Gynecare TVT results in chronic discomfort, as well as the need for multiple invasive surgeries, this quickly becomes a highly distressing, not to mention expensive situation. For this reason, many women have filed lawsuits against its maker and distributer, Johnson & Johnson. Litigation is a powerful option and can be highly beneficial in terms of being compensated for the time, money, and emotional distress associated with Gynecare complications.
If you or a loved one has suffered from the complications of using Johnson & Johnson’s Gynecare TVT for pelvic organ prolapse, a lawsuit against its producers may be the right course of action for you to pursue. The Willis Law Firm is currently reviewing and accepting cases against the makers of transvaginal mesh; please call us today. We have female consultants trained to evaluate your potential case today. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).