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The U.S. Food and Drug Administration has issued a new draft guidance document calling for a boxed warning and delineation of risks with breast implants.
The FDA has stated: "In a draft guidance issued today, we are providing proposed labeling recommendations to manufacturers of these devices to help ensure women receive and understand information regarding the benefits and risks of breast implants. The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient decision checklist in the device's labeling, update recommendations for patient screening for device rupture and more."
This document follows on the heels of a public advisory panel meeting we held earlier this year.
The FDA has proposed a boxed warning be included in labeling for breast implants and that the manufacturers delineate certain risks, including the risk of complications, additional surgery, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and along with systemic symptoms (like fatigue or joint pain).
The draft guidance also recommends revising the rupture screening recommendations for patients with silicone gel-filled breast implants, including screening for rupture, with magnetic resonance imaging (MRI) or ultrasound 5-6 years following implantation and then every two years thereafter.