ASPS reviewing new FDA draft guidance on breast-implant labeling
ASPS is conducting a rigorous review of "Breast Implants – Certain Labeling Recommendations to Improve Patient Communication," a draft guidance released Wednesday by the FDA that centers on manufacturer information accompanying breast implants. Once ASPS completes its review of the multi-point guidance, the Society will submit comments to the FDA by the Dec. 23 response deadline.
This guidance, which essentially serves as an adjunct to existing related guidance, is designed to ensure patients receive and understand the benefits and risks of breast implants – including the risk of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), as well as symptoms commonly referred to as breast-implant illness (BII).
The FDA is recommending that manufacturers include the following with packaging for breast implants:
- "Black box" warning
- Patient-decision checklist
- Device/materials descriptions, including types and quantities of chemicals and heavy metals that reside in, or are released by, breast implants
- Silicone gel-filled breast implant rupture-screening recommendations
- Updated patient device card
"Since the FDA hearing this past March, ASPS has been working with numerous stakeholders to shape the content and intent of a patient-decision checklist and black box warning that provides useful information to patients so they can make an informed decision," says ASPS President Lynn Jeffers, MD, MBA. "Patient safety is always the top priority of the Society and our members."
ASPS leaders conducted a meeting with patient advocates as well as Binita Ashar, MD, director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health, during Plastic Surgery The Meeting last month in San Diego to identify areas in which all parties can work more closely together to improve the flow of information to patients.
"These discussions were tremendously valuable, and further collaboration is underway to improve patient safety," says Dr. Jeffers.
Public comment on the draft guidance can be delivered electronically at www.regulations.gov under docket number FDA-2019-D-4467. Those with questions about the draft guidance are advised to contact the Division of Industry and Consumer Education.