Silicone-gel filled breast implants are a step closer to returning to the market.
The Food and Drug Administration (FDA) yesterday told Mentor that its implants meet the criteria for approval, one of several steps on the way to a final OK. The company still must meet certain conditions before the implants are allowed back on the market.
The implants have been banned for 13 years because of health concerns. On April 13, an FDA advisory committee voted 7-2 to recommend allowing them back on the market under certain conditions.
Among those conditions were ensuring that women understand the devices may break silently inside their bodies; recommending that women get regular MRI exams to check for those breaks; allowing only specially trained plastic surgeons to be able to perform implant insertions; and requiring new studies to prove how long implants last.
