UPDATE: FDA acts to increase the safe use of laparoscopic power morcellators Today, the U.S. Food and Drug Administration (FDA) is issuing two updates to promote the safe use of laparoscopic power morcellators during gynecologic surgery: - A safety communication providing updated recommendations for health care providers on the use of laparoscopic power morcellators.
- Availability of an updated final guidance, "Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff."
The guidance includes recommendations, including but not limited to: - For a boxed warning that uterine tissue may contain unsuspected cancer and the use of laparoscopic power morcellators during fibroid surgery may spread cancer.
- For contraindications against using laparoscopic power morcellators in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain cancer, and for removal of uterine tissue containing suspected fibroids in certain patients, including patients who are post-menopausal or over 50 years of age.
This guidance supersedes "Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators," issued on November 25, 2014. Facts about the final guidance This final guidance provides device manufacturers with updated recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators to better inform patients and health care providers of the device's risks, including: - Greater specificity regarding the risk of use as it relates to age of the patient
- Information regarding the risk of spreading malignant and benign uterine tissue
- Information regarding the use of laparoscopic power morcellation containment systems
Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education. | 
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