Breast Implant Labeling: Patient Communication and Risk Information Requirements
This guidance provides recommendations for breast implant labeling to improve patient communication and understanding of benefits and risks. It applies to saline and silicone gel-filled breast implants indicated for breast augmentation or reconstruction. The guidance aims to ensure patients receive and understand key information before deciding to get breast implants.
Recommended Actions
- Update all patient labeling materials to include:
- New boxed warning
- Patient decision checklist
- Updated rupture screening recommendations
- Materials/device description
- Revised patient device card
- Develop process to:
- Review and update risk information regularly
- Maintain website with current labeling information
- Track and incorporate post-market safety data
- Implement new informed consent process using:
- Patient decision checklist
- Documentation of physician-patient discussion
- Acknowledgment of risks through signatures
- Create tracking system for:
- Distribution of patient device cards
- Registry participation information
- Post-market surveillance data
- Train physicians on:
- New labeling requirements
- Use of patient decision checklist
- Documentation requirements
- Updated screening recommendations
Key Considerations
Human Factors
- Patient decision checklist must be provided and reviewed with patient before surgery
- Checklist should allow patients and physicians to acknowledge review through initials/signatures
- Information should be presented in an understandable format for patients
Labeling
- Must include boxed warning highlighting key risks
- Patient information booklet/brochure required with specific content
- Patient device card must be provided after surgery with device-specific information
- Materials/device description detailing implant components and chemicals
- Updated rupture screening recommendations for silicone implants
- Clear presentation of BIA-ALCL risks and incidence rates
Biocompatibility
- Must include information about chemicals and heavy metals in implants
- Need to explain potential for gel bleed and material diffusion
- Should address biocompatibility testing and risk assessments performed
Safety
- Must clearly communicate all known risks and complications
- Include updated rupture screening recommendations
- Provide information about BIA-ALCL risks and symptoms
- Address systemic symptoms reported by some patients
Other considerations
- Manufacturers should develop plan to ensure adequate patient information
- Regular updates to risk information based on post-market experience
- Dedicated website link for updates to labeling information
- Registry participation information should be provided
Relevant Guidances
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
- Writing Medical Device Patient Labeling: Content and Design Considerations
Original guidance
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