After the first status report of the FDA on a possible association of breast implants and the incidence of ALCL in January 2011, the agency released an update on Breast-Implant Associated ALCL (BIA-ALCL) on 21 March 2017. At the time, the FDA had received 359 reports on BIA-ALCL. In their update, the FDA confirms that the disease is rare and provides several sources of evidence to this effect.
Presently, the agency does not recommend a change of handling pertaining to the use of breast implants in breast augmentation or reconstruction surgery. For patients who already have implants and are without symptoms, the FDA sees no need for action. Patients who suffer from pain and swelling are requested to make an appointment with their health-care provider to exclude any suspicion of BIA-ALCL.
Health-care providers are called upon to include the discussion of the low risk of BIA-ALCL, among that of other possible complications, in their pre-operative patient education and the informed consent.