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

Barron, Kenneth I., MD; Richard, Tere, BA; Robinson, Patricia S., PhD, ARNP; Lamvu, Georgine, MD, MPH

doi: 10.1097/AOG.0000000000001111
Contents: Original Research
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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

Minimally invasive hysterectomies and myomectomies decreased during the 8 months after the U.S. Food and Drug Administration's warning statement on power morcellation.

Advanced and Minimally Invasive Gynecology, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education, and the Center for Women's and Children's Research and Outcomes, Florida Hospital, and the Department of Obstetrics and Gynecology, University of Central Florida College of Medicine, Orlando, Florida.

Corresponding author: Kenneth I. Barron, MD, 2415 North Orange Avenue, Suite 300, Orlando, FL 32804; e-mail: kenneth.barron.md@gmail.com.

Presented at the 44th AAGL Global Congress on Minimally Invasive Gynecology, November 15–19, 2015, Las Vegas, Nevada.

Financial Disclosure The authors did not report any potential conflicts of interest.

During the past 30 years, the field of minimally invasive gynecologic surgery has expanded significantly. Patients benefit from decreased length of hospital stay, decreased postoperative pain, quicker return to routine activities, and decreased morbidity and mortality associated with minimally invasive surgery techniques for hysterectomy.1 Patients also benefit from decreased blood loss and faster recovery associated with minimally invasive myomectomies.2,32,3 Extirpation of large uteri and large myomas is a challenge in minimally invasive surgery. Kurt Semm4 first described laparoscopic morcellation in 1991 as a method for removing a specimen in pieces through laparoscopic ports without the need to make larger abdominal incisions. This method was improved with the invention of electromechanical, or power, morcellation, which uses a spinning blade to morcellate a specimen.5,65,6 From 2006 to 2012, 16% of minimally invasive hysterectomies used power morcellation.7 It is presumed that power morcellation has increased the rate of minimally invasive myomectomy, but those data have never been reported.

On April 17, 2014, the U.S. Food and Drug Administration (FDA) released a warning statement discouraging the use of power morcellation for leiomyomas because of the risk of iatrogenic dissemination of malignant tissue in the event of an unsuspected sarcoma.8 As a result of the FDA statement, many leading hospitals, including our institution (Florida Hospital), banned the use of power morcellators for myoma surgery.

There is concern among gynecologists that the actions of the FDA and hospitals will lead surgeons to perform more hysterectomies using laparotomy rather than minimally invasive techniques. This may in turn lead to increased morbidity and mortality that is already associated with abdominal hysterectomy.1,9,101,9,101,9,10

To evaluate whether there was a change in surgical practice immediately after the FDA announcement, we examined hysterectomies and myomectomies at Florida Hospital for the 8 months preceding compared with the 8 months after the announcement. We hypothesized there would be a significant increase in abdominal procedures and corresponding decrease in minimally invasive procedures.

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MATERIALS AND METHODS

We performed a time-series analysis of all gynecologic surgical cases in the Florida Hospital System between August 1, 2013, and December 31, 2014. The data set consisted of deidentified surgical case logs from the Florida Hospital operating room documentation system. Data were entered by the operating room staff at the end of each case after verifying diagnoses and procedures with the surgeon. The study was exempted from a full review by the Florida Hospital institutional review board because it only examined deidentified data. Cases were drawn from six operating centers in the Florida Hospital medical system and 98 total surgeons. Combined, these hospitals perform an average of 2,400 hysterectomies a year.

Our cohort included all hysterectomies and myomectomies performed in the 8 months before the FDA warning announcement and the 8 months after. We excluded hysteroscopic myomectomies because the standard of care at our institution is to offer patients hysteroscopic resection primarily if a myoma can be removed hysteroscopically. The decision for hysteroscopic removal of a myoma was therefore not expected to be influenced by the FDA announcement. We included cases from gynecologic oncologists because at our institution 30% of their hysterectomies are for benign indications. However, a separate analysis was conducted excluding gynecologic oncology patients.

Subanalysis was performed by subspecialty and included gynecologic oncologists, urogynecologists, reproductive endocrinologists, and minimally invasive gynecologic specialists. Minimally invasive gynecologic specialists included the American Association of Gynecologic Laparoscopists Minimally Invasive Gynecology Surgery Fellowship trained surgeons and American Association of Gynecologic Laparoscopists fellowship faculty and current fellows. For the purpose of analysis, the date of the surgery (before the FDA announcement or after) was used as our dichotomous exposure and surgical approach was used as our outcome of interest. The preannouncement group consisted of cases from August 1, 2013, through April 17, 2014, and the postannouncement group consisted of cases from April 18, 2014, through December 31, 2014. This time point was chosen because the use of power morcellation for myomas was suspended in our hospital system immediately after the warning.

We considered a case to be minimally invasive if it involved vaginal, laparoscopic, or robotic-assisted laparoscopic approaches. These included total laparoscopic hysterectomy, laparoscopic-assisted vaginal hysterectomy, laparoscopic supracervical hysterectomy, robotic-assisted total laparoscopic hysterectomy, robotic-assisted supracervical hysterectomy, and laparoscopic single-site hysterectomy. Laparoscopic-assisted vaginal hysterectomies were included in the total laparoscopic hysterectomy group and robotic-assisted supracervical hysterectomies were included in the robotic-assisted total laparoscopic hysterectomy group because there were only five of these procedures performed during the study period. Cases that were performed through laparoscopic or robotic techniques were considered minimally invasive even if a minilaparotomy was used to remove the uterus or leiomyomas. The minimally invasive myomectomy group included laparoscopic and robotic-assisted laparoscopic myomectomies.

Data analysis was completed using SPSS 22.0 for frequencies and descriptive data. Bivariate analysis for significance was completed using χ2 and Z-tests from an online calculator (www.socscistatistics.com) or SPSS 22.0.

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RESULTS

In the pre-FDA warning cohort, there were 1,694 hysterectomies and 102 myomectomies that met inclusion criteria. In the post-FDA warning cohort, there were 1,690 hysterectomies and 87 myomectomies that met inclusion criteria. Patient demographics are presented in Table 1. The two cohorts were similar in age, race, and body mass index, but there was a significant difference in insurance type (P<.001). Descriptive statistics for hysterectomy and myomectomy volume stratified by procedure type are presented in Tables 2 and 3, respectively.

Table 1

Table 1

Table 2

Table 2

Table 3

Table 3

Before the FDA warning 1,451 (85.7%) hysterectomies were performed using minimally invasive techniques. After the FDA warning 1,350 (79.9%) hysterectomies were performed using minimally invasive techniques (Fig. 1A). Overall, there was a 5.8% decrease in minimally invasive hysterectomies (P<.001) and when all gynecologic oncology cases were excluded, there was an even larger 8.7% decrease (P<.001). When categorized by subspecialty (Fig. 1B) there was a decrease in minimally invasive hysterectomies performed by obstetrician–gynecologists (ob-gyns) (85.9% compared with 77.5%; P<.001) and minimally invasive gynecologic specialists (98.7% compared with 90.2%; P<.001), but not urogynecologists or oncologists. This decrease in minimally invasive hysterectomies is almost entirely driven by a 60% decrease in laparoscopic supracervical hysterectomies after the FDA warning (236/1,694 compared with 95/1,690; P<.001).

A

A

Myomectomy data are shown in Figure 2A. Before the FDA warning 64 (62.7%) myomectomies were performed using minimally invasive techniques. After the FDA warning 38 (43.7%) myomectomies were performed using minimally invasive techniques for a 19% decrease between the two study periods (P=.009). When categorized by subspecialty (Fig. 2B) there was a decrease in minimally invasive myomectomies performed by reproductive endocrinologists (80% compared with 38%; P=.006) and minimally invasive gynecologic specialists (81.6% compared with 56.4%, P=.01), but not ob-gyns. There were insufficient cases to analyze myomectomies by urogynecologists (n=4) and there were no myomectomies by gynecologic oncologists.

A

A

As mentioned, we found a greater number of uninsured patients in the post-FDA warning cohort (P<.001). Therefore, we performed a stratified analysis of surgery rates by insurance status. When comparing the proportion of minimally invasive hysterectomies and myomectomies stratified by insurance status, there was no difference among uninsured patients between the two time periods (P=.802 and P=.893, respectively).

We also performed a stratified analysis to evaluate the effect of surgeon experience out of concern that individual surgeon volume might influence our outcome of interest (Table 4). With 98 surgeons in our study population, it was not feasible to control for each individual surgeon. Therefore, we categorized surgeons by surgical volume during the study period and compared the top 25% with the bottom 75%. High-volume myomectomy surgeons (nine or more myomectomies per study period) had a decrease in minimally invasive myomectomies after the FDA announcement (P=.001), whereas low-volume surgeons did not (P=.880). Both high-volume (30 or more hysterectomies per study period) and low-volume hysterectomy surgeons had a decrease in minimally invasive hysterectomies after the FDA warning (P<.001 and P=.024, respectively), although the decrease was more remarkable in the low-volume group (83.1% compared with 66.1%). Seven surgeons in our population performed more than 100 hysterectomies during the study time period. The overall decreased rate of minimally invasive hysterectomy was still significantly different even after individually extracting each of those surgeons from our analysis.

Table 4

Table 4

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DISCUSSION

Our study shows a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed in the Florida Hospital System during the 8 months after the FDA warning on power morcellation compared with the 8 months before. This change in practice pattern is most evident in the 19% decrease in minimally invasive myomectomies and the 60% decrease in laparoscopic supracervical hysterectomies.

The variation in hysterectomy and myomectomy approach after the FDA announcement was subspecialty-dependent. We suspect that ob-gyns and minimally invasive gynecologic specialists, who perform more leiomyoma-related hysterectomies that other specialists, altered their practice in direct response to the FDA warning and change in hospital policy. There was no change in gynecologic oncologists' or urogynecologists' hysterectomy approach. The absence of any significant change is most likely because neither group was frequently using power morcellation to begin with and not the result of case volume because both groups were adequately powered.

The majority of minimally invasive myomectomies at our institution is performed by reproductive endocrinologists and minimally invasive gynecologic specialists. Both groups had a significant decline in the number of minimally invasive cases, which we again attribute to the FDA warning and change in hospital policy. There was no change in minimally invasive myomectomies performed by ob-gyns because they performed too few minimally invasive myomectomies at baseline to adequately power an analysis.

Our data demonstrated an overall decrease in minimally invasive hysterectomies since the FDA announcement between 5.8% and 8.7% depending on whether oncologist cases are included. If our findings are reproducible in a national cohort, and with 433,000 hysterectomies performed in the United States each year,11 21,700–39,000 additional women could be undergoing a laparotomy annually.

At the time of submission, there were no other studies measuring change in minimally invasive surgery since the FDA warning. The only previously published data were a survey of American Association of Gynecologic Laparoscopists Minimally Invasive Gynecologic Surgery Fellowship faculty asking about change in practice since the FDA warning.12 That study, however, only captured 29% of the reachable faculty and did not incorporate community ob-gyns. Our study reports data from a hospital system that includes a large population of community, academic, and subspecialist ob-gyns. We are therefore able to report on a relatively large volume of cases over a short period of time and find statistically significant changes.

Our study has several limitations regarding generalizability of the results. We report the experience of a single hospital system in central Florida and changes in practice patterns may differ at other institutions. Our system has a higher rate of minimally invasive hysterectomies than the national average11 and could also be more affected (or less) by the decreased use of power morcellators than other hospital systems. Additionally, there was an increase in the percentage of uninsured patients in our study population after the FDA warning, but this did not affect minimally invasive surgery rates when stratified by insurance type.

Minimally invasive surgery rates were affected by surgeon volume in our stratified analysis. Although both high- and low-volume surgeon groups saw a decrease in minimally invasive hysterectomy, the difference was less significant in the high-volume group. We believe this can be explained by a higher comfort level or desire to alter the surgical technique to avoid laparotomy. We suspect myomectomy rates were not affected in the low-volume group because the overall rate of minimally invasive myomectomy was lower to begin with or there was not enough statistical power to detect a difference.

Caution should be taken in interpreting this data to mean there has been an irreversible backslide toward open surgery. Our results reflect the immediate change in surgical practice after a policy change, and this might be neutralized once newer techniques for removing myomas and myomatous uteri by minimally invasive measures are adopted more broadly. If we find that the overall rate of minimally invasive surgery remains the same and there is only a decrease in minimally invasive supracervical hysterectomies, there is little lost for patients; data have not shown significant clinical benefit for laparoscopic supracervical hysterectomies compared with total laparoscopic hysterectomies to begin with.13,1413,14

However, our data show a large percentage of the minimally invasive supracervical hysterectomies became open cases. Analysis of nononcologist hysterectomy data (gynecologic oncologists did not perform any supracervical hysterectomies) shows a 12.3% decrease (236/1,092 down to 95/1,023) in the overall proportion of supracervical hysterectomies after the FDA announcement with only a 6.5% rise in total laparoscopic and robotic-assisted hysterectomies (585/1,092 up to 621/1,023) to account for both the decrease in supracervical hysterectomies and a 3.5% decrease in vaginal hysterectomies.

We do not believe the decrease in vaginal hysterectomies is directly related to the FDA warning because there does not seem to be a plausible correlation. We do suspect there is a general trend at our institution, and nationally, toward less vaginal and abdominal hysterectomies and more laparoscopic and robotic hysterectomies.11,1511,15

Seidhoff et al16 recently published a decision analysis that predicted fewer overall deaths with continued rates of minimally invasive hysterectomy compared with abdominal hysterectomy even when accounting for morcellation and upstaging of leiomyosarcomas. Quality-adjusted life-year analysis also favored minimally invasive hysterectomy even when accounting for a 20% variation in the utility measures of various outcomes. Bortoletto et al17 recently published a cost-effectiveness decision analysis showing that it would cost $10,540,832 to prevent one case of disseminated leiomyosarcoma by abandoning morcellation in exchange for a negligible increase in quality-adjusted life-years. If there is truly a sustained increase in abdominal surgery as a result of the FDA announcement and resultant hospital policy changes, we risk subjecting our patients to higher mortality and morbidity at a greater cost to society for little or no increase in quality of life.

Further research is needed to evaluate for sustained change in surgical practice over the long term, particularly on a national level. Additionally, such research should be accompanied by evaluation of surgical outcome data to determine if, as expected, there is an increase in surgical morbidity with 21,700 and 39,000 additional laparotomies a year in the United States.

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