Breast Implants: FDA Issues Draft Guidance on Certain Labeling Recommendations

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Certain Labeling Recommendations for Breast Implants – Considerations to Improve Patient Communication.

Read the draft guidance This draft guidance, when finalized, will provide manufacturers of breast implants with certain labeling recommendations to help ensure that patients receive and understand the benefits and risks of breast implants, including the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms commonly referred to as breast implant illness (BII). Specifically, the draft guidance provides recommendations for the content and format of product labeling, including: Boxed warning Patient decision checklist Materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants  Silicone gel filled breast implant rupture screening recommendations Patient device card Submit comments on this draft guidance  This draft guidance, including the proposed labeling recommendations and the benefit/ risk information, will be open for public comments for 60 days, through December 23, 2019, at www.regulations.gov under docket number FDA-2019-D-4467. Submit comments Questions? If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.