FDA nod for tissue containment in power morcellation comes amid ongoing review of cancer concerns

Ethicon's Morcellex Sigma Tissue Morcellator

Irish startup Advanced Surgical Concepts has nabbed an FDA nod for its tissue containment system for use with certain laparoscopic power morcellators. The regulatory go-ahead falls under the agency's de novo process that's reserved for low- to moderate-risk devices that are novel.

Power morcellation is at the center of a years-long controversy surrounding its role in potentially spreading previously undetected cancer throughout a patient's body when the minimally invasive procedure is used for hysterectomy or uterine fibroid removal. The procedure works by shredding the tissue targeted for extraction, eliminating the need for invasive surgery.

The tissue containment system, PneumoLiner, is specifically cleared by FDA for uterine tissue that is not suspected to contain cancer. The idea is to contain what is thought to be noncancerous tissue, thereby reducing the likelihood that any tissue is distributed further into the body during power morcellation. But these are precisely the types of cases, where no cancer was previously suspected, that have been seen as problematic for use of the procedure. The agency estimates that about 1 in 350 women who undergo hysterectomy or fibroid removal have unsuspected uterine cancer.

"The PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option--and only if patients have been appropriately informed of the risks," said Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, in a statement.

He continued, "This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids."

Most recently, one major power morcellator maker, Johnson & Johnson ($JNJ) has moved to settle about 70 out of the 100 cases against it on this front. The settlements reportedly range in the $100,000 to $1 million range per woman. Although several prominent doctors recently came out in defense of the procedure, it already carries a 'black box' warning from the FDA that dates back to 2014. And some insurers have backed away from reimbursing for it in light of the controversy.

The FDA said it "continues to review information on laparoscopic power morcellation, including the latest data and evolving scientific literature, and will communicate publically on any developments that are pertinent to the agency's thinking on this issue."

An approach like the PneumoLiner from the Bray, Ireland-based endoscopic surgical device startup may be a first step in moving ahead in the power morcellation quagmire. The device includes a containment bag and a tube-like plunger to deliver it into the abdominal cavity. The tissue to be removed is placed in the bag, which is then sealed and inflated. Then morcellation occurs inside the sealed bag.

Visualization during morcellation is used to prevent any breakage of the containment bag, which was found in testing to be impermeable to substances similar in molecular size to tissues, cells and body fluids. The bag has already been stress tested to demonstrate that it can withstand forces in excess of what's expected in actual use.

The PneumoLiner is cleared by the FDA specifically for women without uterine fibroids who are undergoing a hysterectomy and some premenopausal women with fibroids who want to keep their uterus, thereby maintaining their fertility.

Cautioned FDA's Maisel, "We want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery."

- here is the FDA statement