FDA OKs Marketing of Morcellation Tissue Containment System

Marcia Frellick

Disclosures

April 07, 2016

The US Food and Drug Administration (FDA) today permitted the marketing of the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.

However, the FDA is requiring the manufacturer of the device, called PneumoLiner, to warn patients and their healthcare providers that it has not been proven to reduce the risk of spreading cancer during these procedures.

The FDA estimates that about 1 in 350 women who have hysterectomy or myomectomy for fibroids will have an unsuspected uterine sarcoma.

If morcellation, or the shredding and removal of tissue, is performed on them, there is a risk that the cancerous tissue could spread to the abdomen and pelvis and significantly threaten long-term survival.

"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," William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a news release.

"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," Dr Maisel added.

The FDA says the PneumoLiner is intended as an alternative to more invasive surgery only in very limited cases, including women without uterine fibroids undergoing hysterectomy and some premenopausal women with fibroids who want to preserve fertility.

Risks of the device include dissemination of shredded tissue, injury to surrounding tissues or organs, and infections.

"The required labeling for the device must state that use of the device is limited to physicians who have successfully completed the company's validated training program," the FDA said.

According to the FDA statement, the device, which consists of a containment bag and tubelike plunger, was tested in laboratories to simulate worst-case scenarios.

"The containment bag was found to be impermeable to substances that were similar in molecular size to tissues, cells and body fluids, and other testing determined that the inflated bag provided adequate space for surgeons to perform morcellation with good visualization. Stress testing to evaluate the bag's mechanical strength demonstrated that the device could withstand forces in excess of those expected to occur in actual clinical use," the FDA statement said.

Morcellation Opponent Furious With Approval

Hooman Noorchashm, MD, a cardiothoracic surgeon, told Medscape Medical News, "I find this a completely astonishing statement. Despite all the demonstrated catastrophe this device has caused, they've gone ahead and approved a device — this federal agency is admitting now that the cancer risk of this device is unknown — and yet they're OK with unleashing it into the marketplace. What do they expect? That gynecologists will use their patients as guinea pigs? It's completely atrocious.... How could they let this device into the marketplace without demanding some sort of clinical study to demonstrate safety?"

Dr Noorchashm has waged a high-profile campaign against gynecological morcellation since his wife, anesthesiologist Amy Reed, MD, PhD, underwent a hysterectomy in 2013 for uterine fibroids at Brigham and Women's Hospital in Boston, Massachusetts. According to the previous Medscape Medical News story, her surgeon used a morcellator to shred the fibroids, believed to be benign, into pieces that were extracted through tiny laparoscopic incisions. A week later, Dr Reed's physicians told her she had an aggressive uterine leiomyosarcoma, and that morcellation may have spread the previously unknown cancer throughout her abdomen, according to her husband.

A subsequent operation confirmed that morcellation and its tissue-scattering action had advanced the cancer to stage IV, Dr Noorchashm said.

Dr Noorchashm said he will continue to advocate recalling all laparoscopic power morcellators.

The PneumoLiner, manufactured by Advanced Surgical Concepts Ltd in Bray, Ireland, was reviewed through the FDA's de novo classification process, used for some first-of-a-kind, novel, low- to moderate-risk medical devices.

The FDA further states that labeling must include these warnings: "Do not use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy; and do not use for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision."

Important Contraindications

Daniel L. Clarke-Pearson, MD, professor and chair of the Department of Obstetrics and Gynecology at University of North Carolina in Chapel Hill, said those contraindications are important, as is informed consent.

He told Medscape Medical News: "While uterine cancers (especially leiomyosarcoma) are extremely rare (and most feel much less common than the 1/350 estimated by the FDA), the patient should be properly informed of her choices and risks before undertaking morcellation within or out of a containment bag."

He said systems similar to this device that have not been approved by the FDA have been used with increasing frequency by providers performing minimally invasive gynecologic surgery to prevent tissue dissemination.

"There is no evidence available to support a decrease in the spread of a uterine leiomyosarcoma between hand morcellation, vaginal morcellation, or power morcellation in contained environments. The benefit of laparoscopic power morcellation is providing appropriate candidates an option of completing a minimally invasive procedure laparoscopically," he said.

Dr Clarke-Pearson added that other specialties, such as urology, have used contained morcellation for known cancer extraction in the setting of minimally invasive kidney removal.

"This device would be most useful in removing a uterus," he said. "However, in performing a myomectomy, the uterus is cut into and manipulated before the myoma (fibroid) would be placed into the containment bag. Thus, if the myoma were cancerous, there would have been spread before placing the myoma in the containment bag."

He said it was disconcerting that the FDA said more than once in its announcement that "it has not been proven to reduce the risk of cancer spread during surgery."

But he agrees with the FDA that proper training of the surgeon is critical.

"There have been vascular and bowel injuries by power morcellators when using a containment bag because the bag itself can obstruct the surgeon's view of adjacent anatomy and thus, the morcellator has penetrated out the opposite side of the bag and injured organs that were not visualized," he said. "I presume this bag is not so strong as to withstand the blades of the power morcellator."

Dr Clarke-Pearson has disclosed no relevant financial relationships.

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