Recently the FDA issued a transvaginal mesh warning concerning the use of the medical device (also known as pelvic mesh, pelvic sling or bladder mesh) as a method to repair pelvic organ prolapse. The FDA warning stated that using transvaginal mesh to repair pelvic organ prolapse exposes patients to an “unnecessary risk” without providing any benefit above safer measures. Next week, the FDA will conduct hearings to determine whether stricter safety measures or a possible recall of the transvaginal mesh is necessary.
Problems from the medical device include pain, bleeding, infection, injury to nearby organ, and protrusion of the mesh through the vagina.
If you have undergone surgery for pelvic organ prolapse and surgeons used the pelvic mesh, it is important to consult with a transvaginal mesh attorney regarding your next steps.
According to an FDA representative, “There are clear risks associated with the transvaginal placement of mesh…The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.” This warning came after the FDA received reports of 1503 adverse events from 2008 to 2010.