Breast Implants - Premarket Requirements for Saline and Silicone Gel-Filled Devices

Recommended Actions

1. Develop comprehensive test plan covering all required non-clinical testing
2. Design clinical study protocol with appropriate cohorts and follow-up schedule
3. Establish robust data collection and monitoring procedures
4. Develop detailed physician and patient labeling materials
5. Create quality system procedures for post-market surveillance
6. Establish training program for physicians
7. Develop protocol for device explant analysis
8. Create procedures for adverse event monitoring and reporting
9. Plan for long-term patient follow-up and registry
10. Establish process for regular labeling updates based on post-market data

Key Considerations

Clinical testing

• Core study with 10 years follow-up required
• Separate patient cohorts for primary augmentation, primary reconstruction, revision-augmentation, and revision-reconstruction
• Minimum 80% follow-up rate recommended at each timepoint
• Regular evaluations at 6-10 weeks, 1 year, and annually through 10 years
• Assessment of complications, rupture, CTD, mammography data
• Patient reported outcomes and satisfaction measures

Non-clinical testing

• Chemistry data including material characterization and analysis
• Toxicology testing including cytotoxicity, systemic toxicity, immunotoxicity
• Mechanical testing including fatigue, valve competency, cohesivity
• Shelf life testing for device and packaging
• Device explant analyses to characterize failure modes

Human Factors

• Patient labeling must be at appropriate reading comprehension level
• Focus group studies may be required to improve patient labeling
• Formal informed decision process recommended

Labelling

• Detailed physician and patient labeling requirements
• Boxed warning required
• Patient decision checklist
• Patient device card
• Materials/device descriptions
• Rupture screening recommendations

Biocompatibility

• Extensive toxicology testing required
• Immunotoxicity assessment
• Reproductive and teratogenicity testing
• Genotoxicity testing
• Implantation testing

Safety

• Detailed safety assessments required for complications
• Rupture monitoring and reporting
• CTD monitoring
• Mammography interference evaluation
• Post-approval safety monitoring

Other considerations

• Post-approval requirements including continued patient follow-up
• Patient registry may be required
• Education and certification program for physicians
• Regular labeling updates based on post-approval findings

  Relevant Guidances

• Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Breast Implant Labeling: Patient Communication and Risk Information Requirements
• Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
• Patient-Reported Outcome Measures: Development, Implementation and Evaluation in Clinical Trials

Related references and norms

• ASTM F2051: Standard Specification for Implantable Saline Filled Breast Prosthesis
• ASTM F703: Standard Specification for Implantable Breast Prostheses
• ASTM F1929: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM D3078: Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
• ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
• ISO 10993-16: Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables

---

Original guidance

• Breast Implants - Premarket Requirements for Saline and Silicone Gel-Filled Devices
• HTML / PDF
• Issue date: 2020-09-29
• Last changed date: 2020-09-28
• Status: FINAL
• Official FDA topics: Medical Devices, Labeling, Premarket, General & Plastic Surgery
• ReguVirta summary file ID: d746461d4f597e8b0ab7428bca54ad74