Breast Implant Labeling: Patient Communication and Risk Information Requirements

What You Need to Know? 👇

What are the new FDA labeling requirements for breast implants to improve patient communication?

The FDA recommends manufacturers include a boxed warning and patient decision checklist in breast implant labeling. These components highlight key risks like BIA-ALCL cancer and systemic symptoms, ensuring patients receive and understand critical safety information before surgery.

How often should patients with silicone gel breast implants undergo rupture screening?

FDA recommends the first ultrasound or MRI at 5-6 years post-surgery, then every 2-3 years thereafter for asymptomatic patients. For symptomatic patients or equivocal ultrasound results, MRI is recommended at any time postoperatively.

What is BIA-ALCL and how does it relate to breast implants?

BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is a cancer of the immune system associated with breast implants. It occurs more commonly with textured implants than smooth ones, and some patients have died from this condition.

What information must be included in the patient device card for breast implants?

The patient device card must include the device’s serial/lot number, style and size, Unique Device Identifier (UDI), web link to current labeling, boxed warning statement, and manufacturer’s toll-free phone number for patient reference.

What materials and chemicals should be disclosed in breast implant labeling?

Manufacturers should provide detailed tables listing breast implant materials, chemicals that might be released (volatiles and extractables), and heavy metals present in implants. This information helps patients make informed decisions about potential exposure risks.

Are there specific contraindications for breast implant candidates that must be communicated?

Yes, patients with active infections, existing untreated breast cancer/pre-cancer, or who are pregnant/nursing are not candidates. Additionally, conditions affecting healing, immunosuppressive medications, and autoimmune diseases may increase surgical risks and complications.

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What You Need to Do 👇

Recommended Actions

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

• 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

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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

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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 ID: 0d641691f48030c886f679bb9aa77cf6