The FDA voiced their concern in a warning issued on July 13, 2011, that the device does not provide the best solution to POP or Stress Urinary Incontinence.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the Center for Devices and Radiological Health.
“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.
Mesh is a permanent implant—complete removal may not be possible and may not result in complete resolution of complications.”