Breast Implants Are Safe, Says FDA

After two days of debates and testimonials, U.S. Food and Drug Administration said that silicone breast implants are safe.

Still the FDA has identified risks involved in the implants, 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 FDA continues to believe that currently marketed silicone breast implants are safe,” said Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices.

At the same time some patients and women’s groups who testified at the meeting disagreed. There was allegation that companies that manufacture silicone breast implants had done a poor job of studying patients who got the implants, as the FDA required them to do.

Companies making silicone breast implants have not followed up on thousands of women who received them as required by the FDA as a condition of approval.

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 asking patients to get MRI’s is that silicone breast implants sometimes rupture without women being aware. An MRI is capable of revealing this unseen problem.

At the same time many patients ignore the requirements because MRI’s are expensive. Also it is not clear what they should do when an unseen rupture is discovered. This is because of the fact that the risk associated with ruptured implants need not be higher than the risk of the surgery needed to take them out.