F.D.A. Affirms Safety of Breast Implants

Gardiner Harris

New York Times| August 31, 2011

WASHINGTON — 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.

Some patients and women’s groups who testified at the meeting disagreed.

Diana Zuckerman, president of the National Research Center for Women and Families, a research and education group, told an expert panel that the two companies that manufacture silicone breast implants — Johnson & Johnson and Allergan — had done a poor job of studying patients who got the implants, as the F.D.A. required them to do.

“And without proper data, we still don’t know how safe or effective they are and whether there are certain patients at risk for extremely negative outcomes,” Ms. Zuckerman said.

Dr. Maisel agreed that the studies conducted by the two companies had failed to follow as many patients as the agency had hoped.

One purpose of this week’s meeting was to ask the expert panel what the agency and the two companies should do about that poor follow-up. Some suggested that patients should be paid for participating; others mentioned that doctors should get some money, too.

There was some criticism of the 27-page research form that patients who participate in the study are required to complete and whether it could be shortened. Nearly all expressed hope that a registry could be created that would follow all breast implant patients, but such registries are expensive to maintain and complicated to create.

The committee also agreed that patients should no longer be told that they should get a magnetic resonance imaging test three years after getting implants and every two years following.

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.