Timeline of FDA Actions to Strengthen Breast Implant Safety Requirements
Pre-2020: Initial Guidelines
2006
FDA issued initial guidance on saline, silicone gel, and alternative breast implants, focusing on safety and effectiveness.
2019: Heightened Concerns and Recommendations
March 2019
FDA convened a panel to discuss breast implant safety concerns, including:
- Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
- Systemic symptoms referred to as Breast Implant Illness (BII)
- Silent ruptures in silicone gel-filled implants
Panel recommended:
- A boxed warning in implant labeling
- A standardized Patient Decision Checklist as part of the informed consent process
- Greater transparency about materials in breast implants
July 2019
FDA requested Allergan voluntarily recall its BIOCELL textured breast implants due to an increased risk of BIA-ALCL.
2020: Final Guidance Issued
September 29, 2020
FDA released final guidance titled "Breast Implants - Certain Labeling Recommendations to Improve Patient Communication."
Recommendations included:
- A boxed warning for all breast implants
- A mandatory Patient Decision Checklist to ensure patients understand risks
- Updated rupture screening recommendations for silicone gel-filled implants
- A patient device card with implant-specific details
2021: Strengthened Labeling and Sale Restrictions
October 27, 2021
FDA implemented new safety measures:
Restricted Sale and Distribution:
- Breast implants could only be sold to healthcare providers who use the Patient Decision Checklist
- Providers must review the checklist with patients, who must sign it along with the implanting surgeon
Updated Labeling Requirements:
- Boxed warning on all breast implants highlighting key risks
- Updated rupture screening guidelines
- Device description detailing materials and chemicals
- Patient device card for tracking implant details
2022–2023: Continued Safety Communications
September 8, 2022
FDA issued a safety alert regarding reports of squamous cell carcinoma (SCC) and other lymphomas in scar tissue around breast implants.
March 8, 2023
FDA updated its safety communication on SCC in the capsule surrounding breast implants.
Key Requirements Introduced by the FDA
Patient Decision Checklist:
- Mandatory for all patients considering breast implants
- Must be reviewed and signed by both patient and implanting physician
Boxed Warning:
Clearly communicates significant risks associated with breast implants
Updated Screening Guidelines:
Recommendations for regular imaging to detect silent ruptures in silicone gel-filled implants
Transparency on Materials:
Manufacturers must disclose materials used in breast implants and chemicals that may be released
Post-Approval Studies (PAS):
Manufacturers are required to conduct long-term studies to monitor safety and effectiveness after approval