Hysterectomy Practice Patterns in the Postmorcellation Era.

OBJECTIVE: To characterize long-term national trends in surgical approach for hysterectomy after the U.S. Food and Drug Administration (FDA) warning against power morcellation for laparoscopic specimen removal. METHODS: This was a descriptive study using data from the American College of Surgeons National Surgical Quality Improvement Program from 2012 to 2016. We identified hysterectomies using Current Procedural Terminology codes. We used an interrupted time-series analysis to evaluate abdominal and supracervical hysterectomy trends surrounding The Wall Street Journal article first reporting morcellation safety concerns and the FDA safety communication. We compared categorical and continuous variables using χ, t, and Wilcoxon rank sum tests. RESULTS: We identified 179,950 hysterectomies; laparoscopy was the most common mode of hysterectomy in every quarter. Before The Wall Street Journal article, there was no significant change in proportion of abdominal hysterectomies (0.3% decrease/quarter, P=.14). After The Wall Street Journal article, use of abdominal hysterectomy increased 1.1% per quarter for two quarters through the FDA warning (P<.001), plateaued for three quarters until March 2015 (P=.65), then decreased by 0.8% per quarter through 2016 (P<.001). Supracervical hysterectomy volume continuously decreased after the FDA warning (1.0% decrease per quarter, P<.001) and after three quarters (0.7% decrease per quarter, P=.01), then plateaued from April 2015 through 2016 (0.05% decrease per quarter, P=.40). Mode of supracervical hysterectomy was unchanged from 2012 to 2013 (P=.43), followed by two quarters of significant increase in proportion of supracervical abdominal hysterectomies (11.7%/quarter, P<.001). This change in mode of supracervical hysterectomy then plateaued through 2016 (P=.06). CONCLUSION: Despite early studies suggesting that minimally invasive hysterectomy decreased in response to safety concerns regarding power morcellation, we found that this effect reversed 1 year after the FDA safety communication. However, there was a sustained decline in supracervical hysterectomy, and the remaining supracervical hysterectomies were more likely to be performed using laparotomy.

Development and history of morcellators.

PURPOSE OF REVIEW: Controversy exists surrounding extraction of tissue in gynecologic surgery using morcellators following cases of disseminated uterine cancers discovered after the use of electromechanical morcellators. This chapter traces the history of tissue extraction in gynecology and reviews the evolving scientific data and opinions regarding the future of morcellation. RECENT FINDINGS: Since the initial Food and Drug Administration warning about morcellation in 2014, subsequent studies do not support the Food and Drug Administration's high incidence of occult uterine cancer. Current research continues, focusing on methods of contained tissue morcellation, both laparoscopically and vaginally. SUMMARY: Minimally invasive surgical techniques have revolutionized gynecology, drastically reducing the need for open procedures. To maximize patient safety while preserving the rapid recovery and low morbidity of laparoscopic and vaginal approaches, optimal methods of tissue extraction need to be developed and promulgated.

Economics of gynecologic morcellation.

PURPOSE OF REVIEW: As the Food and Drug Administration raised concern over the power morcellator in 2014, the field has seen significant change, with patients and physicians questioning which procedure is safest and most cost-effective. The economic impact of these decisions is poorly understood. RECENT FINDINGS: Multiple new technologies have been developed to allow surgeons to continue to afford patients the many benefits of minimally invasive surgery while minimizing the risks of power morcellation. At the same time, researchers have focused on the true benefits of the power morcellator from a safety and cost perspective, and consistently found that with careful patient selection, by preventing laparotomies, it can be a cost-effective tool. SUMMARY: Changes since 2014 have resulted in new techniques and technologies to allow these minimally invasive procedures to continue to be offered in a safe manner. With this rapid change, physicians are altering their practice and patients are attempting to educate themselves to decide what is best for them. This evolution has allowed us to refocus on the cost implications of new developments, allowing stakeholders the opportunity to maximize patient safety and surgical outcomes while minimizing cost.

Morcellation equipment: past, present, and future.

PURPOSE OF REVIEW: This review was written in an effort to describe the evolution of power morcellation equipment from their creation to their current state. In addition, this review addresses the continuously evolving equipment involved with power morcellation and looks to describe where the field is headed in the future. In addition, recent professional and federal recommendations have changed the way power morcellation is being approached and has led to the development of contained morcellation systems, which, although in their infancy, are also being proven to be well tolerated options. RECENT FINDINGS: This article will review the most current research on electronic power morcellation and the multiple attempts to prove superiority from the many different types of equipment, and also the many different approaches to morcellation. In addition, with the adaptation to contained morcellation, this review will cover research focused on optimizing a containment system and the techniques involved. SUMMARY: In summary, this review is aimed at describing many of the currently available power morcellation products and contained morcellation systems in an effort to allow physicians to understand the different options available, and to discuss well tolerated, effective, and clinically proven techniques that can lead to improved surgical outcomes in the future.

Practice patterns and postoperative complications before and after US Food and Drug Administration safety communication on power morcellation.

BACKGROUND: In April 2014, the US Food and Drug Administration (FDA) published its first safety communication discouraging "the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids." Due to the concern of worsening outcomes for patients with occult uterine malignancy, specifically uterine leiomyosarcoma, the FDA recommended a significant change to existing surgical planning, patient consent, and surgical technique in the United States. OBJECTIVE: We sought to report temporal trends in surgical approach to hysterectomy and postoperative complications before and after the April 17, 2014, FDA safety communication concerning the use of power morcellation during myomectomy or hysterectomy. STUDY DESIGN: A retrospective cohort study was performed with patients undergoing hysterectomy for benign indications in the Michigan Surgical Quality Collaborative from Jan. 1, 2013, through Dec. 31, 2014. The rates of abdominal, laparoscopic, and vaginal hysterectomy, as well as the rates of major postoperative complications and 30-day hospital readmissions and reoperations, were compared before and after April 17, 2014, the date of the original FDA safety communication. Major postoperative complications included blood transfusions, vaginal cuff infection, vaginal cuff dehiscence, ureteral obstruction, vesicovaginal fistula, deep and organ space surgical site infection, acute renal failure, respiratory failure, sepsis, pulmonary embolism, deep vein thrombosis requiring therapy, cerebral vascular accident, cardiac arrest, and death. We calculated the median episode cost related to hysterectomy readmissions using Michigan Value Collaborative data. Analyses were performed using robust multivariable multinomial and logistic regression models. RESULTS: There were 18,299 hysterectomies available for analysis during the study period. In all, 2753 cases were excluded due to an indication for cancer, cervical dysplasia, or endometrial hyperplasia, and 174 cases were excluded due to missing covariate data. Compared to the 15 months preceding the FDA safety communication, in the 8 months afterward, utilization of laparoscopic hysterectomies decreased by 4.1% (P = .005) and both abdominal and vaginal hysterectomies increased (1.7%, P = .112 and 2.4%, P = .012, respectively). Major surgical complications not including blood transfusions significantly increased after the date of the FDA safety communication, from 2.2-2.8% (P = .015), and the rate of hospital readmission within 30 days also increased from 3.4-4.2% (P = .025). The rate of all major surgical complications or hospital reoperations did not change significantly after the date of the FDA communication (P = .177 and P = .593, respectively). The median risk-adjusted total episode cost for readmissions was $5847 (interquartile range $5478-10,389). CONCLUSION: Following the April 2014 FDA safety communication regarding power morcellation, utilization of minimally invasive hysterectomy decreased, and major surgical, nontransfusion complications and 30-day hospital readmissions increased.

What is the Future of Open Intraperitoneal Power-Morcellation of Fibroids?

In November 2014, the Food and Drug Administration (FDA) calculated that for every 498 women having surgery for presumed fibroids, one woman would be found to have an occult leiomyosarcoma (LMS). The FDA issued a safety communication warning against the use of laparoscopic morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids. This communication was prompted by concern that if a patient had an occult LMS, the morcellator might spread tumor cells within the peritoneal cavity. We submit that the FDA directive was based on a flawed and misleading analysis. More rigorous evidence estimates the prevalence of LMS among women operated upon for presumed uterine fibroids at approximately one in 2000 women, significantly lower than the FDA's estimate. In addition, there is no reliable evidence that morcellation influences survival or that power-morcellation is inferior to vaginal or mini-lap morcellation with a scalpel. Recent publication shows that open surgery carries more risk for women when compared with minimally invasive surgery. Although the possibility of occult LMS should be considered by women and their gynecologists, we suggest that current morcellation techniques be continued for women who wish to benefit from minimally invasive surgery. Investigation into new and, hopefully, better morcellating devices may make the procedure safer for women.

Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myomectomy.

OBJECTIVE: To evaluate whether there was a change in surgical practice immediately after the U.S. Food and Drug Administration (FDA) warning statement discouraging the use of power morcellation in the surgical treatment of uterine leiomyomas. METHODS: We performed a time-series analysis. Surgical case logs from the Florida Hospital operating room documentation system were used to retrospectively identify patients who underwent a hysterectomy or myomectomy between August 1, 2013, and December 31, 2014. Cases performed during the 8 months before the FDA announcement on April 17, 2014, were compared with cases performed during the 8 months after the FDA announcement. Six hospitals and 98 surgeons were included. We compared the proportion of minimally invasive surgery cases (vaginal, laparoscopic, or robotic-assisted) for each study period. RESULTS: There was a 5.8% decrease in minimally invasive hysterectomies after the FDA warning statement (85.7% [1,451/1,694] compared with 79.9% [1,350/1,690]; P<.001) and an 8.7% decrease when oncologist cases were excluded (90.2% [985/1,092] compared with 81.5% [834/1,023]; P<.001). There was a 19% decrease in minimally invasive myomectomies (62.7% [64/102] compared with 43.7% [38/87]; P=.009). Analysis by subspecialty showed a significant decrease in minimally invasive hysterectomies by obstetrician-gynecologists (ob-gyns) and minimally invasive gynecologic specialists but not urogynecologists or oncologists and a significant decrease in minimally invasive myomectomies by reproductive endocrinologists and minimally invasive gynecologic specialists but not ob-gyns. CONCLUSION: There was a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation. LEVEL OF EVIDENCE: II.

Intrauterine Morcellator Devices: The Icon of Hysteroscopic Future or Merely a Marketing Image? A Systematic Review Regarding Safety, Efficacy, Advantages, and Contraindications.

The aim of this study was to analyze all available evidence regarding the use of intrauterine morcellator (IUM), for treatment of the most prevalent intrauterine benign lesions, compared to both traditional resectoscopy and conventional outpatient operative hysteroscopy in terms of safety, efficacy, contraindications, perioperative complications, operating time, and estimated learning curve. We reported data regarding a total of 1185 patients. Concerning polypectomy and myomectomy procedures, IUM systems demonstrated a better outcome in terms of operative time and fluid deficit compared to standard surgical procedures. Complication rates in the inpatient setting were as follows: 0.02% for IUM using Truclear 8.0 (Smith & Nephew Endoscopy, Andover, Massachusetts) and 0.4% for resectoscopic hysteroscopy. No complications were described using Versapoint devices. Office polipectomy reported a total complication rate of 10.1% using Versapoint device (Ethicon Women's Health and Urology, Somerville, New Jersey) and 1.6% using Truclear 5.0 (Smith & Nephew Endoscopy). The reported recurrence rate after polypectomy was 9.8% using Versapoint device and 2.6% using Truclear 8.0. Finally, the reported intraoperative and postoperative complication rate of IUM related to removal of placental remnants using Truclear 8.0 and MyoSure (Hologic, Marlborough, Massachusetts) was 12.3%. The available evidence allows us to consider IUM devices as a safe, effective, and cost-effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. Evidence regarding Truclear 5.0 suggests that it may represent the best choice for office hysteroscopy. Further studies are needed to confirm the available evidence and to validate the long-term safety of IUM in procedures for which current data are not exhaustive (placental remnants removal).