For the second time, four Democratic lawmakers are seeking hearings into two controversial medical devices, the Lap-Band surgical weight loss device, made by Allergan Inc. and transvaginal meshes made by Johnson & Johnson. In a letter sent last week, the group, led by U.S. Representative Henry Waxman of California, asserts that both transvaginal mesh products [...]
Boston Scientific: Vaginal Mesh Does Not Require Tougher Regulation
On September 8-9, 2011 the FDA held a meeting of the Obstetrics & Gynecology Devices Advisory Committee to debate the use of vaginal mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). One of the manufacturers of these devices, Boston Scientific, issued a statement after the advisory committee meeting basically stating [...]
FDA Advisory Panel Weighs Vaginal Mesh Dangers
It is no secret that there has been some majors concerns of using surgical mesh to repair Pelvic Organ Prolapse (POP) (Check out our recent articles on the vaginal mesh dangers here, here and here). Now the Food and Drug Administration (FDA) identified serious safety and effectiveness concerns over the use of the for the transvaginal [...]
Public Citizen group calls on FDA for transvaginal mesh recall
A public advocacy group, Public Citizen, founded by Ralph Nader, is asking the U.S. Food and Drug Administration to recall transvaginal surgical mesh products that help repair pelvic organ prolapse and stress urinary incontinence, just as the industry is preparing a broad response. Public Citizen wants the FDA to require manufacturers to recall non-absorbable surgical [...]
Incontinence treatment linked to vaginal erosion
Many women are experiencing a very sensitive, embarrassing problem, and are looking for ways to help it. Their incontinence has gotten out of control, and they are seeking medical intervention. The only problem is that one of the treatment options, transvaginal mesh, may cause more harm than good. So, if you are considering treatment options [...]