Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization

What You Need to Know? 👇

What are the key labeling requirements for hysteroscopically-placed tubal implants?

FDA requires a boxed warning highlighting significant adverse events and a patient decision checklist covering risks, benefits, contraindications, and informed consent. Both must be included in product labeling to ensure patients understand the permanent nature and potential complications of these sterilization devices.

How effective are permanent hysteroscopic tubal implants for sterilization?

Based on clinical studies, approximately 8% of women cannot rely on the device for contraception after placement attempts. For those who can rely on it, the unintended pregnancy rate is less than 1% at 5 years, though no contraceptive method is 100% effective.

What are the most common adverse events during hysteroscopic tubal implant placement?

Common events include cramping (up to 30%), mild to moderate pain (up to 13%), nausea/vomiting (up to 11%), dizziness/lightheadedness (up to 9%), and vaginal bleeding (up to 7%). Patients should contact their doctor if symptoms worsen or persist beyond one week.

What materials are used in hysteroscopic tubal implants and what are the allergy risks?

These implants contain metals including nickel, titanium, iron, chromium, and tin, plus polyethylene terephthalate (PET). Some women may develop allergic reactions with symptoms like rash and itching, even without prior sensitivity history. No reliable pre-implantation allergy test exists.

When is surgical removal of hysteroscopic tubal implants necessary?

Removal may be required for persistent pain, allergic reactions, device perforation (1-4% rate), migration to abdomen/pelvis, or other complications. Removal requires surgery and in complicated cases may necessitate hysterectomy. Insurance coverage for removal procedures is not guaranteed.

What follow-up is required after hysteroscopic tubal implant placement?

Patients must use alternative contraception for typically 3 months post-placement, then undergo a confirmation test to verify proper device positioning before relying solely on the implant. The confirmation test may not be covered by insurance, and some patients may still require alternative contraception afterward.

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What You Need to Do 👇

Recommended Actions

1. Develop comprehensive boxed warning following provided format
2. Create detailed patient decision checklist incorporating all required elements
3. Implement process for checklist distribution, signing, and record-keeping
4. Establish system for periodic updates to labeling based on post-market data
5. Train physicians on proper use of labeling materials and risk communication
6. Create process to audit compliance with labeling requirements
7. Develop plan for managing adverse event reports and updating risk information
8. Establish clear protocol for device removal requests and referrals
9. Create patient education materials supporting labeling information
10. Maintain documentation of all labeling-related processes and updates

Key Considerations

Human Factors

• Patient must understand and acknowledge the permanent nature of the device
• Patient must demonstrate understanding of risks and benefits through checklist completion
• Physician must confirm discussion of risks and benefits with patient

Labelling

• Must include a boxed warning highlighting significant/common adverse events
• Must include a patient decision checklist covering:
  • Permanent nature of sterilization
  • Alternative contraceptive options
  • Contraindications
  • Required follow-up steps
  • Effectiveness and pregnancy risks
  • Adverse events (short and long-term)
  • Warning signs requiring medical attention
  • Device materials and associated risks
  • Removal information
• Checklist must be signed by both patient and physician
• Copy of checklist should be provided to patient

Biocompatibility

• Must disclose device materials and potential allergic/hypersensitivity reactions
• Must include MRI safety information if applicable

Safety

• Must detail significant adverse events from clinical trials and post-market experience
• Must include warning signs requiring prompt medical evaluation
• Must describe risks associated with device removal

Other considerations

• Manufacturers should develop plan to audit checklist distribution and signing
• Checklist should be periodically updated based on post-market data
• Device removal coverage by insurance should be addressed

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Relevant Guidances 🔗

• Special Controls for Implanted Blood Access Devices for Hemodialysis
• Applying Human Factors Engineering and Usability Engineering to Medical Devices
• Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
• Device Labeling Requirements and Content for Premarket Approval Applications
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices

Related references and norms 📂

NO_SPECIFIC_REFERENCES_MENTIONED

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Original guidance

• Labeling Requirements for Permanent Hysteroscopic Tubal Implants for Female Sterilization
• HTML / PDF
• Issue date: 2016-10-31
• Last changed date: 2019-02-09
• Status: FINAL
• Official FDA topics: Adverse Event Reporting System (FAERS), Medical Devices, Gastroenterology-Urology, Postmarket, Adverse Event Reporting, 510(k), Biostatistics, Labeling
• ReguVirta ID: e5837982d08fdb3abc48da2a76f7efc3