Women who underwent hysterectomy for uterine fibroids experienced statistically and clinically significant increases in major and minor complications after the US Food and Drug Administration (FDA) warned against the use of laparoscopic power morcellation during these procedures in November 2014, a large new study has found.
The researchers say these increases resulted from an uptick in open abdominal surgeries that occurred after the warning.
“The results of two surveys of gynecologists evaluating the influence of the FDA warning on management strategies in hysterectomy and myomectomy showed that a large proportion of respondents shifted from the use of minimally invasive surgery [MIS] to the use of a larger incision or open abdominal procedures, raising concerns about an increase of surgical complications,” they write.
“Furthermore, the FDA decision was criticized for overestimating the risk associated with using power morcellation compared with the risk associated with preventing its use in a large group of women who could receive benefits from morcellation.”
Francesco Multinu, MD, from the Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, and Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Italy, and colleagues reported their findings April 11 in JAMA Surgery.
The FDA’s warning followed an April 2014 statement “discouraging” the use of laparoscopic power morcellation during surgical removal of uterine fibroids.
Hysterectomy Routes Changed Significantly
Multinu and colleagues analyzed data from 603 hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database to compare post-hysterectomy complications before and after the warning. They excluded hysterectomies that were performed during the transitional period between the two FDA statements.
The study included 75,487 women who underwent hysterectomies for benign gynecologic conditions and a subset of 25,571 women who underwent hysterectomies for removal of uterine fibroids. Non-Hispanic white women comprised most (59.4%) of the total population, followed by African American women (15.1%).
Among the larger cohort, open abdominal hysterectomy rose from 24.0% during the pre-FDA warning period to 26.1% during the post-FDA period (from the fourth quarter of 2014 through the fourth quarter of 2015). The use of MIS fell from 57.3% during the pre-FDA period to 55.4% during the post-FDA period, whereas vaginal hysterectomy dropped from 18.7% to 18.4% during the two periods, changes that were all significant (P < .001).
Among women with uterine fibroids, the change in hysterectomy route from the pre-FDA to the post-FDA period was more marked. The rate of open abdominal surgery rose from 37.2% to 43.0%, the rate of MIS fell from 56.1% to 49.7%, and the vaginal hysterectomy rate grew from 6.7% to 7.3% (P < .001).
Complications Up After Warning for Women With Uterine Fibroids
Among those who underwent surgery for benign gynecologic conditions, 1639 (2.2%) experienced 30-day major complications, as did a similar proportion of those with uterine fibroids, 556 (2.2%), the researchers explain.
Overall, major and minor complications remained stable before and after the FDA-issued warning.
But among the subset of 25,571 women (33.9%) who underwent hysterectomy for uterine fibroids, major complications significantly increased after the FDA-issued warning from 1.9% to 2.4% (adjusted odds ratio [OR], 1.23; P = .02), and minor complications significantly increased from 2.7% to 3.3% (adjusted OR, 1.21; P = .01).
Major complications were defined as “unplanned intubation, wound disruption, ventilator use of more than 48 hours, sepsis, septic shock or systemic inflammatory response syndrome, pneumonia, deep incisional surgical site infection, acute renal failure, organ space surgical site infection, progressive renal insufficiency, pulmonary embolism, myocardial infarction, cardiac arrest requiring cardiopulmonary resuscitation, stroke or cerebrovascular accident with neurological deficit, deep vein thrombosis, or thrombophlebitis.”
Minor complications were defined as any urinary tract infection or superficial surgical site infection.
“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” the researchers write.
Rates of major complications were significantly higher among those with uterine fibroids who underwent open abdominal surgery (2.8%) compared with MIS (1.8%) and vaginal hysterectomy (1.8%) (P < .001).
Among the same group (uterine fibroids), 777 (3.0%) experienced minor complications during the first 30 days, with rates slightly higher among those who underwent open hysterectomy (3.3%) and vaginal hysterectomy (3.2%) compared with MIS (2.8%), a difference that was not significant (P = .07).
Discuss Options With Individual Patients
The study’s strengths include a large sample size from a prospective multicenter database and reliable data collection. Limitations include its retrospective design and potential for bias. In addition, the study could not assess long-term complications as the ACS NSQIP only follows patients for 30 days.
The researchers were also unable to assess whether changes in hysterectomy routes after the FDA’s warning were linked to a reduced prevalence of disseminating unexpected malignant neoplasms. And they had insufficient data to determine whether the increased number of complications could have increased costs and delayed patients returning to work.
“That potential harms were associated with decreased rates of MIS following reduced morcellation use should be considered by clinicians and patients during shared decision-making and by regulatory bodies and medical societies issuing communications on minimally invasive hysterectomy and morcellation among women with uterine fibroids,” they note
“Until new studies discover either preoperative techniques to identify patients with sarcomas or alternative intraoperative technology, such as contained power morcellation to remove a large uterus from the abdominal cavity without disseminating tissue, the decision regarding the surgical approach should be guided by the values and informed preferences of the patient,” they add.
“Further research is warranted focusing on the refinement of these alternative techniques of uterine morcellation and on the identification of women who would benefit from MIS,” the researchers conclude.
The authors have disclosed no relevant financial relationships The authors have reported no relevant financial relationships..
JAMA Surgery. Published online April 11, 2018. Abstract
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