Anne M. Klene underwent several procedures to treat pelvic organ prolapse and stress urinary incontinence during which transvaginal mesh was used, but she claims the devices were defective and caused her to develop hyper-inflammatory responses resulting in lifelong pain. She and her husband Richard T. Klene have filed a lawsuit against manufacturers of her transvaginal mesh claiming the companies were negligent and fraudulent in designing and marketing a defective medical device.
The Klene’s lawsuit was filed in St. Clair County Circuit Court against Boston Scientific Corporation, Boston Scientific Sales, Mentor Worldwide, and Johnson & Johnson. Their lawsuit seeks compensatory and punitive damages as well as attorney fees and other relief.
Transvaginal mesh, also known as bladder sling, has been used for years to treat common pelvic floor disorders in women. A growing number of reports of complications led the Food and Drug Administration (FDA) in 2008 to launch an investigation which resulted in a safety advisory that complications from transvaginal mesh could result in erosion, infection, pain, urinary problems and organ perforation. Three years later, the agency issued another notice, this time saying the number of complications with the devices had risen sharply in recent years and that these problems were not rare.
Many women were left with lifelong problems including chronic pelvic pain, urinary tract infections, bleeding, painful intercourse, urinary and/or fecal incontinence, organ damage, and leg pain.
The Klines’ lawsuit is one of thousands that have been waged against the manufacturers of transvaginal mesh. Some lawsuits have been tried with victims receiving millions in compensation.
Source: The Madison-St. Clair Record