Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
This guidance provides recommendations for labeling information of Laparoscopic Power Morcellators (LPMs) used in gynecologic surgeries, regardless of their morcellation mechanism. It applies to LPMs with either general or specific gynecologic indications but excludes those specifically indicated only for non-gynecologic surgery and hysteroscopic morcellators.
What You Need to Know? 👇
What are the key contraindications for laparoscopic power morcellators in gynecologic surgery?
LPMs are contraindicated when tissue is known or suspected to contain malignancy, and for fibroid removal in post-menopausal women, patients over 50, or those suitable for en bloc tissue removal via vagina or mini-laparotomy.
Why does FDA require a boxed warning for laparoscopic power morcellators?
The boxed warning alerts physicians that uterine tissue may contain unsuspected cancer and that LPM use during fibroid surgery may spread cancer, potentially decreasing long-term patient survival rates.
What is the relationship between patient age and cancer risk in morcellation procedures?
The risk of occult uterine cancer, including sarcoma, increases with age, particularly in women over 50 years old. This age-related risk factor significantly impacts the benefit-risk profile of using LPMs.
Are containment systems mandatory when using laparoscopic power morcellators?
Yes, FDA recommends that LPMs should only be used with compatible containment systems. However, containment systems cannot prevent cancer spread from pre-procedure manipulation or existing metastatic disease through blood/lymphatic systems.
What are the risks of spreading benign tissue during power morcellation?
Uncontained power morcellation can spread benign uterine tissue, causing parasitic myomas and disseminated peritoneal leiomyomatosis. These conditions may require additional surgeries due to symptoms like abdominal pain and distension.
Does this FDA guidance apply to all types of morcellators used in surgery?
No, this guidance specifically applies to laparoscopic power morcellators used in gynecologic procedures. It does not cover hysteroscopic morcellators or LPMs indicated only for non-gynecologic surgery, as they pose different risk profiles.
What You Need to Do 👇
Recommended Actions
- Update device labeling to include the required boxed warning
- Implement all specified contraindications in the labeling
- Add all required warnings regarding age-related risks
- Include information about containment system requirements
- Submit both current and revised labeling to CDRH
- Provide updated labeling to existing device purchasers
- Ensure compatibility with appropriate containment systems
- Include information about the risks of spreading both malignant and benign tissue
- Update physician and patient information materials to reflect all new labeling requirements
- Submit labeling changes as an “add-to-file” to existing 510(k) clearances
Key Considerations
Labelling
- Must include a boxed warning about the risk of spreading unsuspected cancer
- Must include specific contraindications for use in known/suspected malignancy cases
- Must include contraindications for specific patient populations (post-menopausal, over 50 years)
- Must include warnings about increased cancer risk with age
- Must include warnings about spread of benign tissue
- Must include information about containment system requirements
Safety
- Must be used with a compatible containment system
- Should not be used in cases of known or suspected malignancy
- Should not be used in patients who are candidates for en bloc tissue removal
Other considerations
- Age-related risk considerations must be taken into account
- Pre-operative screening should be conducted while acknowledging its limitations
- Physician-patient discussion of benefits and risks is essential
Relevant Guidances 🔗
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
Related references and norms 📂
- 21 CFR 884.4050: Gynecologic laparoscopic power morcellation containment system
Original guidance
- Product Labeling Requirements for Laparoscopic Power Morcellators in Gynecologic Surgery
- HTML / PDF
- Issue date: 2020-12-30
- Last changed date: 2020-12-29
- Status: FINAL
- Official FDA topics: Medical Devices, Errors, Obstetrical & Gynecological, Postmarket, and Problems, General & Plastic Surgery, 510(k), Labeling, Premarket, Safety - Issues
- ReguVirta ID: 4940a64845fb5c0e737c401f8d202b51