Preview Newsletter
Morcellation Coverage
-
Use of electric power morcellation for hysterectomy declines following FDA warning
Aug 23, 2016 | Medical Xpress
In a study appearing in the August 23/30 issue of JAMA, Jason D. Wright, M.D., of the Columbia University College of Physicians and Surgeons, New York, and colleagues examined trends in the route of hysterectomy (abdominal, minimally invasive, or vaginal), use of electric power morcellators (a procedure in which the uterus is fragmented into smaller pieces, and may result in the spread of undetected malignancies), and prevalence of abnormal pathology before and after a Food and Drug Administration (FDA) warning. -
Use of power morcellation for hysterectomy on the decline
Aug 23, 2016 | UPI
By Stephen Feller
Although they were not used in most hysterectomies, the use of electric power morcellators in the procedures has declined significantly since the U.S. Food and Drug Administration recommended against them two years ago, report researchers in New York. -
Power morcellation dropped, abdominal hysterectomy increased after FDA warning
Aug 23, 2016 | OBGYN News
By Mary Ann Moon
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.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Coverage
Full Text of Stories Below
-
Use of electric power morcellation for hysterectomy declines following FDA warning
Aug 23, 2016 | Medical Xpress
In a study appearing in the August 23/30 issue of JAMA, Jason D. Wright, M.D., of the Columbia University College of Physicians and Surgeons, New York, and colleagues examined trends in the route of hysterectomy (abdominal, minimally invasive, or vaginal), use of electric power morcellators (a procedure in which the uterus is fragmented into smaller pieces, and may result in the spread of undetected malignancies), and prevalence of abnormal pathology before and after a Food and Drug Administration (FDA) warning.
Concern about the safety of electric power morcellation for gynecologic surgeryled the FDA to issue a safety communication in April 2014 discouraging use of the devices and, in November 2014, to recommend against use of morcellation in perimenopausal and postmenopausal women. Concern has been raised that these actions may result in performance of a greater number of hysterectomies via laparotomy (surgical incision into the abdominal wall), with an increased risk of complications.
The study included women age 18 to 95 years who underwent hysterectomy from 2013 to the first quarter of 2015 recorded in the Perspective database, which includes more than 500 hospitals across the United States and approximately 15 percent of hospitalized patients. Outcomes were compared before and after the FDA's alert in April 2014.
The researchers identified 203,520 women, including 117,653 women (58 percent) who underwent minimally invasive hysterectomy. Among women who underwent minimally invasive hysterectomy, power morcellation was used in 13.5 percent in Q1 2013, peaked at 13.7 percent by Q4 2013, and declined to 2.8 percent by Q1 2015. The overall complication rate was unchanged over time. Complications declined for abdominal hysterectomy, attributable to a decline in intraoperative complications, but were stable for minimally invasive hysterectomy andvaginal hysterectomy. The prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior in women who underwent morcellation were unchanged.
"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. Continued caution is needed to limit the inadvertent morcellation of uterine pathology," the authors write.
-
Use of power morcellation for hysterectomy on the decline
Aug 23, 2016 | UPI
By Stephen Feller
Although they were not used in most hysterectomies, the use of electric power morcellators in the procedures has declined significantly since the U.S. Food and Drug Administration recommended against them two years ago, report researchers in New York.
Researchers at Columbia University found the use of morcellators dropped by nearly 80 percent after the FDA suggested they be phased out over concerns they could spread unknown cancer when used, according to a study published in the Journal of the American Medical Association.
Electric power morcellators are used in procedures involving the uterus being fragmented into smaller pieces during laparoscopic hysterectomies.
With several studies raising concern the devices may increase the risk of spreading unknown cancerous cells to other parts of the body, the FDA in 2013 first warned doctors of the potential safety risk. Months later, they fully recommended the devices no longer be used.
The agency based its recommendation on estimates that 1 in 350 women undergoing hysterectomy or myomectomy has an unsuspected uterine sarcoma, a type of cancer that can be difficult to detect. Using morcellation, they said at the time, can cause cancerous tissue to spread in the abdomen or pelvis.
To determine if doctors heeded the warning, researchers at Columbia University College of Medicine identified 117,653 women in the Perspective medical database -- which covers about 500 hospitals in the United States and 15 percent of all hospitalized patients in the country -- who underwent minimally invasive hysterectomy.
In 2013, just before the FDA issued its initial warning, about 13.5 percent of hysterectomy patients underwent power morcellation, a number that increased to 13.7 percent after the warning at the end of 2013. The researchers found, however, that use of the device in procedures dropped to 2.8 percent of by the beginning of 2015.
"The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection," researchers wrote in the study. "However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology. Continued caution is needed to limit the inadvertent morcellation of uterine pathology."
-
Power morcellation dropped, abdominal hysterectomy increased after FDA warning
Aug 23, 2016 | OBGYN News
By Mary Ann Moon
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.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Coverage
Full Text of Stories Below
Add recipients
Suggested