October 21, 2011
Finkelstein Thompson LLP Announces An Investigation Involving Complications from Transvaginal Mesh.
Finkelstein Thompson LLP announces an investigation involving women who have allegedly suffered severe complications as a result of the Bard Avaulta Pelvic Floor Repair Systems, and related mesh products. These are medical devices, commonly referred to as pelvic mesh and bladder slings, which are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These medical devices are made of polypropylene mesh. Complications allegedly caused by transvaginal repair with surgical mesh include mesh erosion, pain, and urinary problems. Sometimes these complications allegedly require a follow up surgery to correct the surgery or leave the woman completely debilitated.
On July 13, 2011, the FDA issued a strongly worded report and warnings based on the growing number of complaints of injuries suffered by the victims of vaginal mesh and bladder slings reported to the FDA and a review of current medical literature and studies. Specifically, the FDA stated: (i) Complications related to transvaginal mesh surgery are NOT rare; (ii) There is no evidence that transvaginal mesh repair is more effective than traditional non mesh repair; and (iii) Transvaginal mesh surgery exposes patients to greater risk than traditional non mesh repair.
On September 7, 2011, the Wall Street Journal, Bloomberg News, and ABC News each reported that because of safety concerns over transvaginal mesh devices an FDA panel is recommending that these devices should not be approved for surgical repair of pelvic organ prolapse (POP) through the less-rigorous FDA approval process.