MedPage Today (here) reports an FDA advisory panel meeting over synthetic mesh used to treat stress urinary incontinence (SUI) said it would like more scientific data on the newer generation of devices but recommended leaving in place the 510(k) approval process.
The Obstetrics and Gynecology Devices panel issued its opinion after hearing presentations by FDA staff, industry, and mesh injured patients. MedPage reports that since the 1990s there have been 78 mesh devices approved to treat stress urinary incontinence (SUI) and between 2008 and 2010 there were 1,131 injuries, 236 malfunctions and other adverse events reviewed by the FDA staff. The harm entries to the little-known FDA MAUDE database are thought to represent a small fraction of those in the real world. MAUDE includes three deaths, two of which were bowel perforations related to mesh surgery and one death from mesh removal. Other side effects include pain, erosion, infection, organ perforation, recurrence of incontinence, and re-operation.
Manufacturers do not want a reclassification of mesh for SUI to high risk or Class III because of the additional millions of dollars in scientific clinical trials to demonstrate the safety and efficacy of the medical device. Leaving SUI mesh Class II may leave the FDA in the position to require the additional data for those devices already on the market. For mini-slings, the latest SUI mesh, panelists said they wanted additional postmarket data for those on the market, and data of safety and efficacy before a new device is submitted for approval.
The conclusion of panelists over mesh for SUI were quite different from Thursday’s session on mesh for the treatment of pelvic organ prolapse (POP). Panelists want that mesh to fall under the regulated Class III.
Mesh implanted through the vagina, or transvaginal mesh, was the subject of an FDA alert in July to patients and doctors to the increasing number of devastating problems and suggested POP mesh may not offer greater benefit over the risks. #