Monthly Archives: July 2011
FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.
This is the second notice issued by the FDA on the complications association with synthetic surgical mesh. This one, issued July 13, 2011, says: “Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. [continue reading…]
This report, in U.S. News and World Report, says about 90% of the 4,000 applications for new medical devices through 510(k) are approved and reach the market every year. That is 3,000 devices and the current program of approval for the market for products such as pacemakers and hip implants does not guarantee safety, [continue reading…]
In a major red flag, the Institute of Medicine (IOM) says the Food and Drug Administration’s (FDA) process for clearing medical devices and protecting public health is “fatally flawed” and needs to be replaced.
MSNBC reports on Janet Holt, 54, who underwent surgery for pelvic organ prolapse four years ago, and today reports “the medical device that was supposed to fix Holt’s problem has caused a host of new ones, sparking constant pain and requiring seven more operations as other surgeons tried to remove the mesh, which had [continue reading…]
The Boston Globe reports Wednesday, July 13, that women who have vaginal surgery to fix pelvic organ prolapse may suffer more risk than benefit. Quoting the Food and Drug Administration, the article reports patients and surgeons should consider other options. Natick-based Boston Scientific Corp. along with several other companies will be present September 8 [continue reading…]