Breast Implants - Premarket Requirements for Saline and Silicone Gel-Filled Devices
This guidance outlines the requirements for premarket approval (PMA) applications for breast implants filled with saline, silicone gel, or alternative fillers intended for breast augmentation or reconstruction. It provides detailed recommendations for device description, non-clinical testing, clinical studies, labeling, and post-approval requirements.
What You Need to Know? 👇
What are the key differences between saline-filled, silicone gel-filled, and alternative breast implants?
Saline-filled implants have silicone shells filled with sterile saline solution, silicone gel-filled contain viscous silicone gel, and alternative implants use different filler materials or shell compositions. All require PMA approval and have distinct safety profiles and clinical considerations.
How long should clinical studies run for breast implant PMA approval?
FDA recommends 10 years or more of prospective patient follow-up for Core Studies, with some premarket and postmarket data collection. Minimum premarket data varies: three years for silicone gel implants, two years for saline-filled implants.
What toxicological testing is required for breast implant materials?
Required tests include cytotoxicity, acute systemic toxicity, hemocompatibility, immunotoxicity, reproductive toxicity, teratogenicity, genotoxicity, carcinogenicity, and implantation testing. Testing must be performed separately on both sterilized shell and filler materials.
What mechanical testing is essential for breast implant approval?
Key mechanical tests include fatigue rupture testing of the complete device, valve competency testing (for applicable devices), cohesivity testing for gel-filled implants, bleed testing, and shelf life testing. Testing should mimic in-vivo conditions.
How should silent rupture be monitored in silicone gel breast implants?
FDA recommends MRI screening at 1, 2, 4, 6, 8, and 10 years post-implantation using dedicated breast coils with at least 1.5 Tesla magnets. MRI films should be read by qualified assessors experienced in breast implant imaging.
What patient labeling requirements apply to breast implants?
Patient labeling must include a boxed warning, patient decision checklist, device materials description, rupture screening recommendations, clinical study results, and patient device cards. Information should be written at an easily understood reading comprehension level.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive test plan covering all required non-clinical testing
- Design clinical study protocol with appropriate cohorts and follow-up schedule
- Establish robust data collection and monitoring procedures
- Develop detailed physician and patient labeling materials
- Create quality system procedures for post-market surveillance
- Establish training program for physicians
- Develop protocol for device explant analysis
- Create procedures for adverse event monitoring and reporting
- Plan for long-term patient follow-up and registry
- 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