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Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
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Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
|
Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
|
Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
FROM JAMA
Key clinical point: Electric power morcellation declined after the FDA recommended against using the technique during hysterectomy.
Major finding: Use of electric power morcellation peaked at 13.7% before the FDA recommendations, then declined to a low of 2.8%.
Data source: A retrospective database analysis involving 203,520 hysterectomies performed at more than 500 U.S. hospitals during 2013-2015.
Disclosures: The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
