In the latest transvaginal mesh lawsuit, Debra Wooten, and her husband Ronnie, claim that Boston Scientific knew their transvaginal mesh device, the Tape Obtryx System Curved, was incompatible with human tissue, and chose to sell the device anyway.
The plaintiffs are citing evidence from scientific studies showing that transvaginal mesh made from monofilament polypropalyne triggers the body’s immune response to attack the device and surrounding tissue. The immune system is designed to attack foreign substances, white blood cells attack the medical device, causing the tissue in the area to become inflamed, which causes chronic pain, as well as other adverse reactions.
Ms. Wooten suffered from stress urinary incontinence (SUI), and in 2009 had the device implanted to support her bladder. However, like many other plaintiffs in transvaginal and bladder mesh cases, Ms. Wooten suffered mesh erosion and needed mesh removal surgery. The mesh device had become embedded in her soft tissue, and her surgeon could not remove it all successfully – another common problem with transvaginal mesh implants. The Wootens both claim that the implant has destroyed Debra’s quality of life, as well as their marriage because they cannot have intercourse. The plaintiffs allege that BostonScientific knew, or should reasonably have known, that the device was unfit forimplantation in the human body, and conferred no reasonable benefit that alternatives to transvaginal mesh offered.
Mesh devices are approved through a strange FDA law called 510(k), which allows devices that are similar to a previously-approved device to move through a fast-tracked approval process. The original mesh device, Boston Scientific’s ProteGen, received FDA approval in 1996, but was recalled in 1999 due to complaints and injury. However, in 2002, the FDA approved mesh devices for vaginal and transvaginal implantation, despite complaints against the original device.
The Wootens’ lawsuit has been moved to the Boston Scientific multidistrict litigation, MDL 2326, which is being overseen by the honorable Judge Joseph R. Goodwin in West Virginia. Other MDLs have been consolidated against Johnson & Johnson/Ethicon, American Medical Systems, Mentor, and Coloplast, as well as C.R. Bard, which just lost a case in California, settling for $5.5 million.
If you or a loved one suffer from pelvic organ prolapse or stress urinary incontinence, have received a vaginal or transvaginal mesh device to correct the problem, and have since suffered painful side effects including bleeding, infection, severe pain, inflammation, and continued organ prolapse, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC are accepting cases nationally against transvaginal mesh manufacturers. We offer free consultations to review the facts of your case, so contact us today. 803.252.4800.