FDA Strengthens Its Breast Implant Safety Requirements
On December 15, 2023, the U.S. Food and Drug Administration (FDA) published (https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants) a public update about its work to strengthen safety requirements and consumer communication about risks surrounding breast implants. Through the following actions, FDA said it intended to support patient-provider discussions and shared decision-making for breast implants:
- Explain the risks of breast implants (https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants) and describe the surgical procedures used (https://www.fda.gov/medical-devices/breast-implants/breast-implant-surgery) to implant them.
- Provide information on saline-filled and silicone gel-filled (https://www.fda.gov/medical-devices/breast-implants/types-breast-implants) breast implants, including data supporting a reasonable assurance of safety and effectiveness, approval letters, labeling (https://www.fda.gov/medical-devices/breast-implants/labeling-approved-breast-implants) and information on post-approval studies (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?sb=pdn).
- Provide information on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) (https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl) in patients with breast implants.
- Encourage patients and providers to report adverse events (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program) associated with breast implants through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
The agency said it regularly updates information on the Post-Approval Studies (PAS) Database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm) regarding breast implant manufacturers’ post-approval studies. FDA also took several actions (https://www.fda.gov/news-events/press-announcements/fda-strengthens-safety-requirements-and-updates-study-results-breast-implants) in October 2021 to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions, including restricting the sale and distribution of the following breast implants to help ensure that patients are provided with adequate risk information:
- Allergan Natrelle® silicone gel-filled and saline-filled breast implants
- Ideal Implant structured breast implants
- Mentor® MemoryShape® silicone-filled breast implants
- Mentor® MemoryGel® silicone-filled breast implants
- Mentor® saline-filled and Spectrum® breast implants
- Sientra® Opus silicone gel breast implants
FDA Guidance on Breast Implants
The Breast Implants—Certain Labeling Recommendations to Improve Patient Communication (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication) supplement FDA’s Saline, Silicone Gel, and Alternative Breast Implants guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants), both issued in September 2020. The new labeling approved in October 2021 follows the labeling recommendations described in the September 2020 guidance. It contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants, including:
- Boxed warning (page 4)
- Patient decision checklist (page 5)
- Materials and 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