A Georgia woman believes her Caldera Desara transvaginal mesh device is responsible for seemingly unending pain, persistent revision surgeries and out-of-control medical costs and has filed a lawsuit against two manufacturers.
Sherry Wimbush, along with her husband, Reginald, has entered a complaint against Caldera Medical Inc. and American Medical Systems (AMS). Wimbush claims she was not warned about the potential dangers of a the Caldera Desara bladder sling before having it implanted in December 2009 to treat symptoms of Stress Urinary Incontinence (SUI). If she had been warned of these dangers or in any way foresaw the complications which have altered her life, she would not have followed her doctor’s advice to have it implanted.
Since her surgery, Wimbush has made repeated trips to the surgeon’s table in attempts to correct complications caused by the Caldera Desara sling device. Additionally, according to her complaint filed in U.S. District Court for the Northern District of Georgia, Wimbush claims she suffers from vaginal pain, pelvic pain, bleeding, vaginal pressure and painful intercourse.
Wimbush’s claims echo those of thousands of women across the country who also claim they’ve been injured and continue to suffer because of a defective transvaginal mesh device, either the Caldera Desara specifically, or from a similar device. Transvaginal mesh is the trending option for the treatment of SUI and Pelvic Organ Prolapse (POP) in women. It is surgically implanted and designed to treat the symptoms and effects of those conditions.
In many surgeries however, the transvaginal mesh used has failed in one of several ways, often eroding through the vaginal wall or skin. This causes incredible amounts of pain and alters women’s lives who suffer from a malfunctioned transvaginal mesh. Previous accounts of transvaginal mesh defects have women describing their pain, unable to sit, stand or lay in position for more than a few minutes at a time.
The Food and Drug Administration (FDA) has reports of at least 1,500 cases where a transvaginal mesh device has failed to treat SUI or POP and in the summer of 2011, issued a public safety notice about the growing number of incidents and the potential dangers of the devices.
Transvaginal mesh devices were mostly approved through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that it was similar in design to a previously-approved device.
In making its public safety notice, the FDA ordered makers of transvaginal mesh devices to conduct their own safety testing and report it to the agency.