Silicone Breast Implants Are Safe, FDA Says

Sep 25, 2011

Following two days of hearings, the US Food and Drug Administration has declared that silicone breast implants are safe for use and will remain available. However, the FDA will encourage manufacturers to conduct post-approval studies.

Following two days of hearings, the US Food and Drug Administration has declared that silicone breast implants are safe for use and will remain available. However, the FDA will encourage manufacturers to conduct post-approval studies.

A top official at FDA told the New York Times that nothing in the testimony during the hearings made him believe the devices were anything but safe. “Women should feel assured that the FDA continues to believe that currently marketed silicone breast implants are safe,” Dr William Maisel, chief scientist for the FDA’s Center for Devices, told the Times. “We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days.”

Despite recognizing its relative safety, Maisel acknowledged that there are risks associated with the implants, including ruptures, a hardening of the area around the implants, the need to remove the implants, scarring, pain, infection and asymmetry.

These side effects and a lack of proper follow-up among women who receive silicone implants leave some concerned about the devices’ true safety. Consumer and women advocacy groups and patients testified during the hearings. For instance, Diana Zuckerman, president of the National Research Center for Women and Families, testified at the hearing and voiced her concern about the lack of data to make informed decisions regarding silicone implants’ safety. According to the Times, she said, “Without proper data, we still don’t know how safe or effective they [implants] are and whether there are certain patients at risk for extremely negative outcomes.”

When the FDA lifted its ban on silicone implants in 2006, the agency noted a dearth of data on adverse effects including “rare events” and “long-term performance. As a result, manufacturers were required by the FDA to complete studies on the implants’ safety and performance. Earlier this year, results from six ongoing post-approval studies conducted by Allergan and Mentor, a unit of Johnson & Johnson, did not show an increased risk of breast cancer or connective tissue disease as a result of the silicone implants. However, FDA officials believe longer studies are needed. In addition, although FDA officials believe the chances are slim, they have acknowledged that breast implants might be linked to a higher risk of a rare form of lymphoma called anaplastic large cell lymphoma.

An FDA report further shows that the complications increase with the length of time that the devices are implanted. In a report in June, Dr Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said: “The longer a woman has the implants, the more likely she is to experience complications.” Indeed, the report notes that one in five women who receives silicone implants to increase the size of their breasts and half of the women who receive implants for reconstruction after breast surgery will need to have these devices removed within 10 years due to complications.

Meanwhile, the expert panel at the hearing agreed that the MRI guidance currently given to patients should be stopped. Patients have been told to have an MRI three years after getting their implants and then every two years thereafter to help detect ruptures. Many women ignore the recommendation due to the expense associated with MRIs. Plus, there is no clear consensus as to what to do when a ruptured is discovered, and the risks of removing the ruptured implant may be greater than the risks associated with a ruptured implant.

“[The] FDA continues to believe, as does the panel, that MRI is the gold standard for evaluating breast implants for silent rupture,” Maisel told the Times. “But there was consensus among the panel that the requirements for ongoing MRI’s should be removed.” Maisel added that the FDA would further study the merits of this advice.

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References:

Reference:

Harris G. F.D.A. Affirms safety of breast implants. The New York Times. August 31, 2011.
FDA: Silicone Breast Implants to Remain on Market. HealthDay. Medline Plus. September 1, 2011.