番茄社区

Use of power morcellators in gynecologic procedures declined dramatically following FDA warnings and guidance, but most procedures continue to be performed without recommended containment bags, review of a large healthcare database indicated.

Power morcellator use during laparoscopic supracervical hysterectomy declined from 66.7% of procedures in late 2013 to 13.3% in mid-2018 in the analysis of more than a million women undergoing such procedures. Use of power morcellators decreased by almost 10% each quarter following FDA warnings and guidance beginning in mid-2014.

Yet containment bag use during power morcellation, also recommended by the FDA, increased from 5.2% of procedures in late 2013 to only 15.2% in mid-2018. Use of containment bags for women with uterine cancers or sarcomas did not change substantially post-FDA guidance, reported Jason D. Wright, MD, of Columbia University College of Physicians and Surgeons in New York City, and co-authors, in .

"Among women who undergo power morcellation, either with or without a containment bag, the rates of malignant and premalignant gynecologic abnormalities remain a concern," the authors concluded. "These data have important policy implications. First, further efforts are clearly needed to ensure that morcellation is avoided in women with pathologic abnormalities. Second, despite regulatory approval, the safety and efficacy of containment bags remains uncertain, and the use and outcomes of these devices should be monitored closely."

The authors of an acknowledged the inherent risks of surgery, but also the benefits of laparoscopic procedures versus laparotomy and cautioned against "throwing the baby out with the bath water."

"There is no doubt that surgery carries risk for numerous unintended complications, and no one desires to be the 1 of any number," wrote A. Ben Abdu, MD, and Cameron Lowry, MD, of the University of Tennessee Health Science Center in Memphis. "It is also important to remember that there is a risk of dissemination of malignant tissue whether or not power morcellation is used, and it has even been observed in laparotomy. This current article also points to studies that have demonstrated bag rupture and spillage of tissue even when the containment bag remains intact."

"The advantages of laparoscopy over laparotomy are well known: decreased blood loss, decreased mortality, fewer wound complications and infections, and decreased pain and improved quality of life," they continued. "It is for these reasons that it is of paramount importance to offer minimally invasive surgery whenever feasible and to continue to develop the requisite surgical tools... . It is conceivable that, in the future, the development of risk-stratification models ... could aid in more complete preoperative estimation of individual patient risk for the rare and unfortunate complication that prompted the FDA concerns."

Historically, power morcellators have been used frequently in gynecologic surgery, most often in women with uterine leiomyoma. In 2014, following reports of safety concerns, the FDA issued a safety advisory stating that power morcellators pose "a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas." The agency discouraged use of the devices during hysterectomy or myomectomy.

The FDA subsequently issued additional warnings and advisories regarding safe use of power morcellators, most recently in when the agency recommended use of containment bags for all procedures involving power morcellation.

Noting that "little is known about the use of containment systems," Wright and co-authors sought to examine recent trends in use of laparoscopic power morcellators and in use of containment systems with power morcellators. They queried the Premier Healthcare Database for data on hysterectomy procedures performed from January 2010 to June 2018. The authors then compared trends in use of power morcellators and containment systems before FDA guidance (first quarter of 2010 to first quarter of 2014) and after the communications (second quarter of 2014 to second quarter of 2018).

The search identified 1,037,718 women who underwent nonradical hysterectomy, including 67,115 (6.5%) who underwent laparoscopic supracervical procedures. The rate of laparoscopic supracervical hysterectomy rose from 8.4% in the first quarter of 2010 to 10.0% in the last quarter of 2013 before declining to 3.6% in the second quarter of 2018.

Prior to the initial FDA warnings, use of power morcellators during laparoscopic supracervical hysterectomy exhibited little variation and accounted for 66.7% of procedures by the fourth quarter of 2013. Following the first FDA advisory, use of power morcellators declined almost immediately, falling by 22% by the end of the second quarter of 2014. Thereafter, power morcellator use in laparoscopic supracervical hysterectomy decreased by 9.5% per quarter, reaching 13.3% by the end of the study period.

Paralleling the experience with power morcellators, use of containment systems remained stable prior to the FDA advisories. During the second quarter of 2014, use of containment systems increased by 44%, and the likelihood that a containment system would be used during laparoscopic power morcellation increased by 3% per quarter thereafter.

The trends in power morcellator and containment system use persisted after adjustment for differences in patients' demographic and clinical characteristics.

Among women who underwent procedures with power morcellators, uterine cancers or sarcomas were identified in 0.17% before the FDA advisories and 0.12% afterward. The rate of other gynecologic cancers were 0.05% before the FDA advisories and 0.14% afterward (P=0.02).

Containment systems were used in 11.5% of patients with uterine cancers or sarcomas, 32% of those with other gynecologic cancers, and 9.2% of those with endometrial hyperplasia.

Comment