ABOUT THE DEVICE
According to the FDA, Pelvic organ prolapse and stress urinary incontinence are pelvic disorders affecting millions of women in the United States. They occur when pelvic floor muscles lose strength, allowing pelvic organs, including the bladder and uterus, to descend from their normal location and bulge through the vaginal wall (pelvic organ prolapse), or diminishing bladder xontrol (stress urinary incontinence).
The FDA has received complaints for a number of yearsTransvaginal Mesh (TVM), also known as pelvic sling or hammock implants, have been used for more than two decades to correct stress urinary incontinence and pelvic organ prolapse by supporting the bladder, urethra, uterus, vagina, small bowel or rectum.
The FDA has received complaints for a number of years from doctors reporting poor patient outcomes regarding mesh used in transvaginal surgical repair of pelvic organ prolapse and stress urinary incontinence. According to the FDA reports, these issues include constant pain, infection, mesh erosion (into vagina, bowel, and bladder), and recurrence of prolapse or incontinence.
PURPOSE OF THE DEVICE
For almost 20 years TVM has been used to treat pelvic organ prolapse and stress urinary incontinence. Made of a mesh-like synthetic material, the ends of the implant are secured to the pelvic bones. The devices provide support and stability to the bladder, urethra, uterus, vagina, small bowel or rectum.
Problems emerged long before the FDA in July 2011 said it had received nearly 4,000 complaints of TVM malfunction, injury and even death. Women suffered erosion of the mesh through the vaginal wall, and perforation of the bladder, urethra, bowel or rectum.
Women suffered such physical symptoms that ranged from urinary incontinence and infections; to bleeding; severe pelvic, genital or groin pain; recurrence of prolapse; nerve damage; fistulas; and vaginal scarring.
HOW BRAMZON & ASSOCIATES SPECIALTY LITIGATION LLC CAN HELP
“This is an unprecedented health tsunami that can potentially affect up to several hundred thousand women throughout the globe,” says Lonny Bramzon, an attorney who represents women in TVM and other medical malpractice cases. “Countless innocent women are suffering horribly from physical and psychological trauma.”
What’s worse, multiple surgeries are needed to remove the sling and correct the problem and doctors cannot promise a complete recovery.
Women who believe they might be suffering TVM complications should immediately seek medical treatmentThese staggering complications have prompted the filing of thousands of individual lawsuits and multi-district actions against manufacturers like AMS, Bard Avaulta, Ethicon, and Boston Scientific.
Women who believe they might be suffering TVM complications should immediately seek medical treatment, Bramzon advises. Since most doctors who performed the implant surgery are not skilled at removing the implant or repairing the damage, it is recommended they seek a board certified gynecological surgeon skilled in removing the device.
The next step for many women and their partners is to talk with an attorney, Bramzon says. Because of the personal nature of these cases, some clients may feel more comfortable discussing their matter with female attorneys or paralegals – all at no cost until the case is tried or settled to the plaintiffs’ benefit.
“We listen to the heart-felt stories as women discuss the pain they, and often their husbands or partners, have endured,” says Bramzon. “By educating them about TVM and the legal process, they become informed, lose their vulnerability, and gain a feeling of empowerment. That’s an important first step toward their future.”
Bramzon added he has seen a dramatic increase of interest among patients as the statute of limitations are coming due in various states. He encourages individuals to speak with an attorney since each case has its own set of unique circumstances and specific filing deadlines vary from state-to-state.