FDA May Tag Surgical Mesh for Organ Prolapse as High Risk
In a report issued Wednesday, the U.S. Food and Drug Administration indicated that the agency might classify as high risk surgical mesh devices used to treat organ prolapse, report news sources. The report stated that the devices, which are transvaginally implanted, do not lead to better outcome and may expose patients to greater risk than… read more
Public Citizen Pushes FDA for Recall of Surgical Mesh
Media outlets reported that the consumer advocacy group Public Citizen has formally petitioned the US Food and Drug Administration (FDA) for the recall of all non-absorbable synthetic surgical meshes used in the repair procedure of pelvic organ prolapse (POP). Public Citizen is asking the FDA to recall and ban all marketing of all non-absorbable mesh… read more
Untested Pelvic Mesh Highlights Concerns Over FDA Process (cont.)
News sources say that, according to the FDA, in 2010, doctors performed more than 100,000 prolapse repairs using surgical mesh, and about 75 percent of them were transvaginal. Between 2005 and 2007, the agency received more than 1,000 reports of adverse events related to the mesh in women diagnosed with pelvic organ prolapse or stress… read more
Untested Pelvic Mesh Highlights Concerns Over FDA Process
Janet Holt told media sources that she believed she just had some sort of infection “down there.” But her doctor told her that she was in need of an operation, explaining that her bladder had slipped out of place and created an uncomfortable condition called pelvic organ prolapse, which is common among women as they… read more