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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.

  1. Update all patient labeling materials to include:
    • New boxed warning
    • Patient decision checklist
    • Updated rupture screening recommendations
    • Materials/device description
    • Revised patient device card
  2. Develop process to:
    • Review and update risk information regularly
    • Maintain website with current labeling information
    • Track and incorporate post-market safety data
  3. Implement new informed consent process using:
    • Patient decision checklist
    • Documentation of physician-patient discussion
    • Acknowledgment of risks through signatures
  4. Create tracking system for:
    • Distribution of patient device cards
    • Registry participation information
    • Post-market surveillance data
  5. 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


Original guidance

  • Breast Implant Labeling: Patient Communication and Risk Information Requirements
  • 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: 0d641691f48030c886f679bb9aa77cf6
This post is licensed under CC BY 4.0 by the author.