Medical Device Alert: Avaulta
by Marc Stern on Oct.16, 2009
We are currently investigating claims of women who have experienced serious complications arising out of the implantation of a Bard Avaulta transvaginal surgical mesh device. Manufactured by C.R. Bard, Inc., the Avaulta Solo Support and Avaulta Plus Biosynthetic Support Systems are surgically implanted devices which are designed to help increase bladder control and provide relief from the pain caused by Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). However, there have been numerous reports of mesh-related complications including mesh erosion, extrusion, perforation of the bowel, bladder and blood vessels, infection, vaginal scarring, and recurrence of prolapse or incontinence.
In October 2008, the FDA warned healthcare professionals of the side effects associated with vaginal mesh devices after receiving over one thousand reports over three years from nine surgical mesh manufacturers of complications associated with surgical mesh devices used to repair POP and SUI. In some cases, the pain and discomfort is so severe as to require additional surgery to repair any damage caused by implantation of the device or to remove it altogether.
We will be continuing to monitor concerns about this device. If you’re interested in learning more about these types of cases, drop me a note.