F.D.A. Affirms Safety of Breast Implants

Gardiner Harris The New York Times: Aug 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. […]

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.

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. […]

Read the original article here.