Breast implants safe according to FDA


Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said Wednesday that after two days of discussion and testimony he saw nothing that made him believe that silicone breast implants present any kind of danger to those who have them.

“We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days,” Maisel said.

Though Maisel said he believes in the implants’ safety, he acknowledged that there are risks with breast implants just as there are risks with any kind of cosmetic surgery. Ruptures, a hardening of the area around the implants, the need to remove the implants, scarring, pain, infection and asymmetry are all possible complications when receiving silicone breast implants.

During part of the two-day conference addressing the safety concerns, opponents of the silicone breast implant participated by speaking in front of the panel.

National Research Center for Women and Families President Diana Zuckerman said Johnson & Johnson and Allergen, the two companies who manufacture silicone breast implants, did a less than adequate job of assessing those patients choosing to receive the implants. She argued that they did not meet the minimum standard required by the FDA.

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“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,” said Zuckerman.

One of Zuckerman’s main complaints was that Johnson & Johnson and Allergen did not follow up with as many patients as the FDA would have liked. Maisel said while he was not worried about the safety of the implants, he did agree that more patients should be followed.

Part of the reason for the two days of discussion on the topic was to address the poor follow-up by the manufacturers. Several experts suggested various motivators for follow ups, including compensating both patients and doctors for participating in follow ups.

One of the biggest criticisms of the current process for follow ups was the length of the 27-page form patients are required to fill out if they participate in a follow up. Many agreed it should be shortened. In addition, several participants suggested a registry for those who have breast implants be created, but there was concern about cost and time in regard to maintaining such a large registry.

In addition, the committee agreed that MRIs are no longer necessary for patients receiving silicone breast implants. Previously, it was recommended that implant recipients have an MRI done three years after receiving implants and then every two years after the first one.

While MRIs are the best test to find ruptures, said Maisel, they are costly, causing some to choose not to take the doctor’s recommendation. In addition, surgery to fix ruptures can sometimes be riskier than living with the rupture, which means that even if a rupture is found, some medical professionals are still unsure what to do about it.

Maisel said the FDA would take all recommendations into account when deciding if any changes should be made in protocol concerning silicone breast implants.