The Desara and Mini-Arc Vaginal Mesh Devices Cause a Woman to Have Pain, Failure, and Revision Surgery
The Desara and Mini-Arc are synthetic mesh products designed for use by women suffering from pain, discomfort, and urinary incontinence. Meant to restore and correct normal vaginal structure by implanting polypropylene mesh in the vaginal wall, these devices are promoted as a minimally invasive procedure. There is supposed to be minimal local tissue reactions, minimal pain, and minimal muscle trauma with this vaginal mesh implant to treat stress urinary incontinence (SUI).
However, according to a new lawsuit filed on September 19, 2012, by Janice Ann Rorie in the Superior Court of California-Los Angeles, the vaginal mesh device she had implanted caused her side effects including infection and transvaginal mesh extrusion.
Caldera Medical Inc., and American Medical Systems are named as defendants in the vaginal mesh lawsuit
Named as defendants in the lawsuit are Caldera Medical, Inc. and American Medical Systems—the manufacturers of the Desara and Mini-Arc mesh implants.
Rorie’s lawsuit, seeking judgment of vaginal mesh settlements, accuses the manufacturer of strict liability, failure to warn, negligence, negligent misrepresentation, fraud, fraud by concealment, negligent infliction of emotional distress, and breach of express and implied warranties. She requests compensatory and punitive damages.
The plaintiff had surgery to implant the vaginal mesh in 2008 and two subsequent surgeries to repair it
Rorie received the Desara and Mini-Arc systems to treat her SUI on May 28, 2008. Following the implantation, she alleges that she suffered from infection, hardening of the mesh, bleeding, pain during intercourse, transvaginal mesh extrusion and erosion, and extreme pelvic pain. She underwent a second surgery to excise and alter portions of the implant on September 21, 2009.
A third surgery was performed on June 6, 2012 to remove the Desara and Mini-Arc.
Because of her pelvic mesh implant complications, she filed suit against the manufacturers.
The mesh device is said to be “biologically incompatible with human tissue”
Rorie’s attorney cites scientific evidence that shows the vaginal mesh material is “biologically incompatible with human tissue and promotes a negative immune response.” The negative response can promote inflammation of the pelvic tissue and might contribute to severe adverse reactions to the vaginal mesh.
Both the Desara and Mini-Arc devices have been said to cause hyper-inflammatory responses and led to problems such as chronic pain and fibriotic reaction.
Rorie’s lawsuit says that the vaginal mesh products were marketed as safe, reliable and effective when, the evidence suggests, they weren’t.