FDA Issues Warning About Mesh in Pelvic Prolapse Surgeries
The FDA has warned that opting to place mesh through the vagina in pelvic organ prolapse surgeries could lead to serious complications in future.
The US Food and Drug Administration has warned that opting to place mesh through the vagina in pelvic organ prolapse surgeries could lead to serious complications in future.
In pelvic prolapse surgeries, doctors make use of surgical mesh through either the abdomen or the vagina to repair the prolapse. However FDA has said that using the mesh through the vagina could lead to a number of problems for the patient including the mesh protruding through the vaginal tissue, infection, bleeding or urinary problems.
FDA's William Maisel said that the agency is yet to see any concrete evidence that placing the mesh through the vagina improves the outcome and added that it instead exposed the patients to greater risks.
"We do not see conclusive evidence that using mesh for the transvaginal approach to pelvic organ prolapse improves clinical outcomes anymore than transvaginal procedures that do not use mesh. These devices appear to expose patients to greater risks", he said.
Source: Medindia