The US FDA approved Caldera Medical’s latest version of Vertessa Lite mesh in June 2015, even though there is ongoing controversy about the safety of these type of devices.
Caldera Medical, a startup, makes the product to treat Pelvic Organ Prolapse (POP). The large pore mesh corrects the position of vagina after pelvic organs have bulged into the top of the vagina.
On the flip side of this approval is the fact that another mesh manufacturer, Medtronic, recently paid a huge settlement for more than 11,000 vaginal mesh victims.
The FDA has known since 2011 that dire problems result from transvaginal repair for Pelvic Organ Prolapse.
Indeed, they are considering reclassifying pelvic mesh from a moderate risk or class II device, to the more stringent class III device which necessitates a premarket approval (PMA) application.
The premarket approval application will require manufacturers to provide clinical data to show a reasonable assurance of safety and effectiveness for transvaginal mesh used in POP repair.
Unfortunately, with the recent approval of the updated mesh product, Caldera Medical hasn’t been subject to these more stringent testing procedures. The company is one of many named in more than 70,000 lawsuits regarding transvaginal mesh.
The FDA says that the most common problems with these mesh products are erosion through vaginal epithelium, infection, pain, urinary problems and recurrence of prolapse and/or incontinence.
Our attorneys represent women who have suffered emotionally and physically from defective transvaginal mesh. We continue to research cases and are available to discuss your case during a free case evaluation.
Please contact Carey Danis & Lowe by phone at 800.721.2519 or by completing a confidential personal injury claim form.References: Defective Medical Device litigation, Transvaginal Mesh