FDA Recommends Black Box Warning for Breast Implants
Dr. Kenneth Hughes, Los Angeles Plastic Surgeon, not only keeps up to date on the tremendous amount of continuing medical education or CME but he also keeps up with plastic surgery news, advances in technology, and anything noteworthy really. The breast implant associated anaplastic large cell lymphoma has been discussed in the media and is relatively rare. However, the U.S. Food and Drug Administration announced last week its latest guidelines for breast implant manufacturers, recommending that companies inform patients that their products have been associated with this BIA-ALCL or breast implant associated anaplastic large cell lymphoma. A small percentage of patient deaths have been reported as well.
The FDA recommends a black box warning be applied to breast implants filled with saline or silicone gel but this is a recommendation and not law for breast implant manufacturers.
Some patients also report breast implant illness, which has been less rigorously studied. If a patient believes that he or she has this illness, Dr. Hughes will remove the breast implants at the patient request.
According to the latest FDA guidelines, before implantation, breast implant manufacturers should provide patients with a booklet including the boxed warning and a decision checklist to inform the patients about risks associated with the implants. After surgery, patients should receive a device card with information about their specific device.
The new labeling should also include rupture screening recommendations for physicians and patients, including the use of ultrasound or magnetic resonance imaging for both asymptomatic and symptomatic patients.
Such guidelines remain suggestions and are not law.