April 22, 2011
More Evidence Required: TVM should be restricted to trials, study says
A 2011 study released by the Journal of Obstetrics and Gynecology Canada (JOGC) on transvaginal mesh (TVM) procedures states, "Until adequate effectiveness and safety evidence is available, the use of new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials."
More than 1,000 reports to the Food and Drug Administration about TVM complications prompted the JOGC to conduct this research, and the data suggests that there should potentially be "concerns about adequacy of training and ability to prevent complications" involving TVM systems.
TVM is a type of medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), conditions that may occur after childbirth and pregnancy.
Learn more about how Motley Rice device lawyers are fighting on behalf of patients who may have suffered injuries or complications related to defective medical devices.