Power Morcellation Containment Systems Now Class II Devices

FDA is classifying gynecologic laparoscopic power morcellation containment systems as Class II, special control devices.

Devicemakers submitting a premarket notification for these morcellation containment systems will need to comply with the special controls named in the final order issued on June 21.

On April 8, the FDA approved Advanced Surgical Concepts’ PneumoLiner, the first containment system for use in conjunction with laparoscopic power morcellators intended to isolate uterine tissue that is not suspected to contain cancer.

The gynecologic laparoscopic power morcellation containment systems create a working space allowing for direct visualization during a power morcellation procedure for removing benign tissue that is not suspected to contain malignant tissue.

Morcellators used to shred tumors have been on the market for more than 20 years. The FDA issued a safety alert for the devices in 2014, warning against their use in most women undergoing myomectomy or hysterectomy for treatment of fibroids. The alert said that morcellator blades could spread unsuspected cancers in as many as one in 350 cases.

The controversial devices have received much scrutiny over the past few years, with Congress and the FBI investigating whether devicemakers failed to notify the FDA of suspected risks (IDDM, Nov. 25, 2015).

The FDA required the manufacturer of the containment system to warn patients and healthcare providers that the PneumoLiner has not been proven to reduce the risk of spreading cancer during morcellation procedures (IDDM, April 8).

The Class II designation was based off of the devicemakers’ recommendation for its PneumoLiner device. Subsequent gynecologic laparoscopic power morcellation containment systems will fall under the same classification, according to the final order.

The special controls required to mitigate risk associated with the containment systems include:

• Biocompatibility;
• Sterilization must be validated, and data must support shelf life;
• Non-clinical performance data must meet design specifications;
• Contraindication for use in gynecologic surgery in which tissues to be morcellated is known or suspected to be malignant; and
• Training must be developed and validated to ensure users can follow instructions for use.

The containment systems are not safe for use except under the supervision of a licensed practitioner, and devices must satisfy prescription labeling requirements, the FDA noted.

The agency determined that premarket notification is necessary to ensure safety and effectiveness of these types of devices.

The final order can be found here: www.fdanews.com/06-20-16-PowerMorcellationSystemClassification.pdf. — Joya Patel