F.D.A. Affirms Safety of Breast Implants by reporter, Gardiner Harris /Published: New York Times / August 31, 2011
After two days of discussion and testimony about silicone breast implants, a top government health official said he had heard nothing to shake his faith in the safety of the widely used implants.
The official, Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said silicone breast implants were safe. “We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days,” Dr. Maisel said.
There are risks to the implants, however, Dr. Maisel said, including ruptures, a hardening of the area around the implants, the need to remove the implants, scarring, pain, infection and asymmetry. “Women should feel assured that the F.D.A. continues to believe that currently marketed silicone breast implants are safe,” he said.
The reason for telling patients to get M.R.I.’s is that silicone breast implants sometimes rupture without women being aware, and an M.R.I. can reveal this unseen problem. But many patients ignore the requirements because M.R.I.’s are expensive and it is not clear what they should do when an unseen rupture is discovered; the risks associated with ruptured implants may not be greater than the risks of the operation needed to take them out.
“F.D.A. continues to believe, as does the panel, that M.R.I. is the gold standard for evaluating breast implants for silent rupture,” Dr. Maisel said. “But there was consensus among the panel that the requirements for ongoing M.R.I.’s should be removed.” Dr. Maisel promised that the F.D.A. would study whether to follow this advice.