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Study finds insufflated collection bag successfully used in power morcellation cases


 

FROM OBSTETRICS & GYNECOLOGY

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The use of an insufflated collection bag during minimally invasive hysterectomy or myomectomy that involved a power morcellator was successful in containing morcellation in a small series, according to the authors of the study.

"The benefits of morcellation under direct vision within an insufflated isolation bag include the potential reduction of tissue dissemination while preserving the well-known benefits of minimally invasive gynecologic surgery," said Dr. Sarah Cohen of the division of minimally invasive gynecologic surgery, Brigham and Women’s Hospital, Boston, and her associates (Obstet. Gynecol. 2014;124:491-7).

The technique entails placing the specimen into the 50-by-50-cm bag, insufflated in the peritoneal cavity, and using the power morcellator within the bag, which captures small fragments and fluids. It was used in 73 women who underwent uterine tissue morcellation at four institutions from January 2013 through April 2014; almost 70% had leiomyomas. No perforations were seen in the bags, and visual inspection revealed no dissemination of morcellated material. The technique is "evolving" and needs to be tested further, the investigators said.

The median operative time was 114 minutes (range, 32-380 minutes), and the median estimated blood loss was 50 mL (range, 10-500 mL). The median weight of the specimens was 257 g (range, 53-1,481 g). No cases required conversion to laparotomy, readmission, or reoperation; 78% of patients were discharged home the same day, Dr. Cohen and her associates reported.

In an accompanying editorial, Dr. Charles R. Rardin said that although morcellating within a bag to mitigate the risk of spreading tissue during procedures that involve power morcellation "may appear to be a tempting solution, there are several issues and questions regarding the plausibility, safety, and efficacy of in-bag morcellation" (Obstet. Gynecol. 2014;124:489-90).

This study, which did not formally investigate the integrity of the bag or spread of tissue, primarily addressed "the technical plausibility of in-bag morcellation during laparoscopic myomectomy or hysterectomy (supracervical or total)," he wrote, noting that whether tissue had spread beyond the bag "was essentially assessed by a visual judgment by the surgeon."

Dr. Rardin of the division of urogynecology in the department of obstetrics and gynecology at Women and Infants’ Hospital, Providence, R.I., described the study "as a first scientific step toward understanding whether this is a viable answer."

He did suggest that although comparative data were lacking, gynecologic surgeons should remember their skills at performing vaginal hysterectomy with extraction techniques, the "original minimally invasive surgery."

Before publication of this article, the Food and Drug Administration held a 2-day meeting of its Obstetrics and Gynecology Devices Advisory Panel in July 2014 to discuss the benefits, risks, and clinical role of laparoscopic power morcellators (LPMs) in the treatment of women with uterine fibroids.

Panelists also discussed strategies that might reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma. Two panelists said that LPMs should not be used for gynecologic indications until better data are available, and during the open public hearing, Dr. Hooman Nourchashm, a cardiothoracic surgeon, reiterated his call for a worldwide moratorium on all gynecologic tissue morcellation devices and on the practice of intracorporeal uterine morcellation during minimally invasive hysterectomy. He and his wife, anesthesiologist Amy Reed, who was diagnosed in 2013 with stage IV leiomyosarcoma after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, are leading a campaign calling for the ban.

At the end of July 2014, Ethicon initiated a worldwide withdrawal of the company’s morcellation devices because of the uncertainty over the risk-benefit profile of these devices when used in hysterectomies and myomectomies for women with fibroids, the company announced in a letter. It is the only company manufacturing or distributing LPMs to have done so at press time. There are five other manufacturers or distributors of LPMs with gynecologic indications that have been marketed in the past year, according to the FDA.

Dr. Rardin said he had no relevant financial disclosures. One of the study’s authors, Dr. Tony Shibley, who developed the technique, is developing a device to "facilitate contained morcellation" with Advanced Surgical Concepts, a company based in Dublin. The remaining authors did not report any potential conflicts of interest.

emechcatie@frontlinemedcom.com

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