Morcellation warning drives down minimally invasive gyn surgeries

Minimally invasive myomectomies dropped nearly 20% following the Food and Drug Administration’s warning to avoid power morcellation in the treatment of uterine fibroids, and minimally invasive hysterectomies fell nearly 6%, according to a time-series analysis of a Florida health system.

But the decline in the use of these techniques varied by subspecialty, with ob.gyns. and minimally invasive gynecologic specialists being more likely to shy away from minimally invasive hysterectomy, while reproductive endocrinologists and minimally invasive gynecologists were the subspecialists most likely not to perform minimally invasive myomectomy after the FDA warning, according to the researchers (Obstet Gynecol. 2015;126:1174-80).

On April 17, 2014, the FDA issued a warning against the use of power morcellators in the surgical treatment of uterine leiomyomas because of the risk of iatrogenic dissemination of malignant tissue in the event of an unsuspected sarcoma. In the aftermath of that warning, many hospitals have banned the use of power morcellators for myoma surgery.

Dr. Kenneth I. Barron of Florida Hospital Medical Group, Orlando, and his colleagues performed a time-series, retrospective analysis of 3,573 patients who underwent a hysterectomy or myomectomy between Aug. 1, 2013, and Dec. 31, 2014, to gauge the impact of the warning on gynecologic practice. They compared surgical interventions performed during the 8 months before the FDA announcement with surgical interventions performed during the 8 months after the announcement, quantifying the proportion of minimally invasive vaginal, laparoscopic, or robotic-assisted surgery cases for each study period.

In the pre-FDA warning arm, 1,694 hysterectomies and 102 myomectomies met inclusion criteria; in the post-FDA warning cohort, 1,690 hysterectomies and 87 myomectomies met inclusion criteria. Subjects were drawn from the surgical case logs of the operating room documentation system of the Florida Hospital System, where the use of power morcellation was suspended immediately following the FDA warning. The analysis included six hospitals and 98 surgeons.

During the study period, minimally invasive myomectomies decreased by 19%. The percentage of myomectomies performed with minimally invasive techniques fell from 62.7% before the FDA warning to 43.7% after (P = .009).

Minimally invasive hysterectomies decreased by 5.8%, dropping from 85.7% to 79.9% (P less than .001) following the FDA warning statement. The drop in minimally invasive hysterectomies were due largely to a 60% drop in laparoscopic supracervical hysterectomies, according to the study.

The findings were subspecialty specific. For instance, the researchers observed that there was an 8.7% decrease in minimally invasive hysterectomies when gynecologic oncology cases were excluded from the sample (P less than .001). Ob.gyns. and minimally invasive gynecologic specialists had the greatest decreases in minimally invasive hysterectomies. Significant decreases were not observed with urogynecologists or oncologists.

In terms of minimally invasive myomectomies, there was a drop among reproductive endocrinologists (P = .006) and minimally invasive gynecologic specialists (P = .01), but not among ob.gyns.

“Caution should be taken in interpreting this data to mean there has been an irreversible backslide toward open surgery,” the researchers wrote. “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.”

Minimally invasive myomectomies dropped nearly 20% following the Food and Drug Administration’s warning to avoid power morcellation in the treatment of uterine fibroids, and minimally invasive hysterectomies fell nearly 6%, according to a time-series analysis of a Florida health system.

But the decline in the use of these techniques varied by subspecialty, with ob.gyns. and minimally invasive gynecologic specialists being more likely to shy away from minimally invasive hysterectomy, while reproductive endocrinologists and minimally invasive gynecologists were the subspecialists most likely not to perform minimally invasive myomectomy after the FDA warning, according to the researchers (Obstet Gynecol. 2015;126:1174-80).

On April 17, 2014, the FDA issued a warning against the use of power morcellators in the surgical treatment of uterine leiomyomas because of the risk of iatrogenic dissemination of malignant tissue in the event of an unsuspected sarcoma. In the aftermath of that warning, many hospitals have banned the use of power morcellators for myoma surgery.

Dr. Kenneth I. Barron of Florida Hospital Medical Group, Orlando, and his colleagues performed a time-series, retrospective analysis of 3,573 patients who underwent a hysterectomy or myomectomy between Aug. 1, 2013, and Dec. 31, 2014, to gauge the impact of the warning on gynecologic practice. They compared surgical interventions performed during the 8 months before the FDA announcement with surgical interventions performed during the 8 months after the announcement, quantifying the proportion of minimally invasive vaginal, laparoscopic, or robotic-assisted surgery cases for each study period.

In the pre-FDA warning arm, 1,694 hysterectomies and 102 myomectomies met inclusion criteria; in the post-FDA warning cohort, 1,690 hysterectomies and 87 myomectomies met inclusion criteria. Subjects were drawn from the surgical case logs of the operating room documentation system of the Florida Hospital System, where the use of power morcellation was suspended immediately following the FDA warning. The analysis included six hospitals and 98 surgeons.

During the study period, minimally invasive myomectomies decreased by 19%. The percentage of myomectomies performed with minimally invasive techniques fell from 62.7% before the FDA warning to 43.7% after (P = .009).

Minimally invasive hysterectomies decreased by 5.8%, dropping from 85.7% to 79.9% (P less than .001) following the FDA warning statement. The drop in minimally invasive hysterectomies were due largely to a 60% drop in laparoscopic supracervical hysterectomies, according to the study.

The findings were subspecialty specific. For instance, the researchers observed that there was an 8.7% decrease in minimally invasive hysterectomies when gynecologic oncology cases were excluded from the sample (P less than .001). Ob.gyns. and minimally invasive gynecologic specialists had the greatest decreases in minimally invasive hysterectomies. Significant decreases were not observed with urogynecologists or oncologists.

In terms of minimally invasive myomectomies, there was a drop among reproductive endocrinologists (P = .006) and minimally invasive gynecologic specialists (P = .01), but not among ob.gyns.

“Caution should be taken in interpreting this data to mean there has been an irreversible backslide toward open surgery,” the researchers wrote. “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.”

Minimally invasive myomectomies dropped nearly 20% following the Food and Drug Administration’s warning to avoid power morcellation in the treatment of uterine fibroids, and minimally invasive hysterectomies fell nearly 6%, according to a time-series analysis of a Florida health system.

But the decline in the use of these techniques varied by subspecialty, with ob.gyns. and minimally invasive gynecologic specialists being more likely to shy away from minimally invasive hysterectomy, while reproductive endocrinologists and minimally invasive gynecologists were the subspecialists most likely not to perform minimally invasive myomectomy after the FDA warning, according to the researchers (Obstet Gynecol. 2015;126:1174-80).

On April 17, 2014, the FDA issued a warning against the use of power morcellators in the surgical treatment of uterine leiomyomas because of the risk of iatrogenic dissemination of malignant tissue in the event of an unsuspected sarcoma. In the aftermath of that warning, many hospitals have banned the use of power morcellators for myoma surgery.

Dr. Kenneth I. Barron of Florida Hospital Medical Group, Orlando, and his colleagues performed a time-series, retrospective analysis of 3,573 patients who underwent a hysterectomy or myomectomy between Aug. 1, 2013, and Dec. 31, 2014, to gauge the impact of the warning on gynecologic practice. They compared surgical interventions performed during the 8 months before the FDA announcement with surgical interventions performed during the 8 months after the announcement, quantifying the proportion of minimally invasive vaginal, laparoscopic, or robotic-assisted surgery cases for each study period.

In the pre-FDA warning arm, 1,694 hysterectomies and 102 myomectomies met inclusion criteria; in the post-FDA warning cohort, 1,690 hysterectomies and 87 myomectomies met inclusion criteria. Subjects were drawn from the surgical case logs of the operating room documentation system of the Florida Hospital System, where the use of power morcellation was suspended immediately following the FDA warning. The analysis included six hospitals and 98 surgeons.

During the study period, minimally invasive myomectomies decreased by 19%. The percentage of myomectomies performed with minimally invasive techniques fell from 62.7% before the FDA warning to 43.7% after (P = .009).

Minimally invasive hysterectomies decreased by 5.8%, dropping from 85.7% to 79.9% (P less than .001) following the FDA warning statement. The drop in minimally invasive hysterectomies were due largely to a 60% drop in laparoscopic supracervical hysterectomies, according to the study.

The findings were subspecialty specific. For instance, the researchers observed that there was an 8.7% decrease in minimally invasive hysterectomies when gynecologic oncology cases were excluded from the sample (P less than .001). Ob.gyns. and minimally invasive gynecologic specialists had the greatest decreases in minimally invasive hysterectomies. Significant decreases were not observed with urogynecologists or oncologists.

In terms of minimally invasive myomectomies, there was a drop among reproductive endocrinologists (P = .006) and minimally invasive gynecologic specialists (P = .01), but not among ob.gyns.

“Caution should be taken in interpreting this data to mean there has been an irreversible backslide toward open surgery,” the researchers wrote. “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.”