Medical Device News Magazine

New FDA Guidance and Labeling Changes Affecting PneumoLiner, the Only 510(k)-Cleared Containment Device Reports Olympus

New FDA Draft Guidance Now Mandates Surgeons Use Power Morcellation Only with an Approved Containment System for Gynecological Tissue

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In a recent press release, the FDA states about the PneumoLiner: “While the device itself remains unchanged since its prior marketing authorization, today’s clearance updates the labeling for this device to better define the appropriate patient population for the safe and effective use of this device, including stating that the device should only be used in women who have fibroids if they are pre-menopausal and under 50 years old.”

The FDA safety communication update on power morcellation includes additional recommendations including:

  • That health care providers use tissue containment systems when using laparoscopic power morcellators, and that they ensure the laparoscopic power morcellator and tissue containment system are compatible, legally marketed laparoscopic power morcellation containment systems intended to isolate and contain tissue that is considered benign.
  • As demonstrated in testing, use of a containment system confines morcellated tissue within the containment system, which may prevent the peritoneal spread of cancerous tissue.
  • Laparoscopic power morcellation (with a compatible containment system) should only be used in the appropriate patient population:
    • women without uterine fibroids undergoing hysterectomy
    • and women with fibroids, provided they are pre-menopausal and under age 50 with fibroids (with no suspicion of malignancy).

The leading gynecological laparoscopy association, AAGL, immediately endorsed the FDA’s guidance, with the following statement from its President, Jubilee Brown, MD: “The specification of age-related risk is consistent with scientific data and reflects clinical experience allowing power morcellation in low- risk patients when performed with a containment system compatible with the laparoscopic power morcellator. Utility of a contained tissue extraction system in a low- risk population appears to mitigate the risk of poor outcomes that may be associated with uncontained power morcellation.” The AAGL encouraged its members to submit electronic comments to the FDA’s Federal Register.

These modifications clarify power morcellation usage guidelines along with containment in appropriately selected patients. Further, the FDA clarifies the appropriate patient population by eliminating the ambiguous term “peri-menopausal” from the contraindications, and adds an easier-to-follow age restriction.

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