Changes in Myomectomy Practice After the U.S. Food and Drug Administration Safety Communication on Power Morcellation

Stentz, N.C.; Cooney, Laura G.; Sammel, Mary D.; Shah, Divya

doi:10.1097/aog.0000000000002035

Cited by 51 publications

(24 citation statements)

References 15 publications

(15 reference statements)

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“…The U.S. Food and Drug Administration (FDA) published its initial safety communication, which reported that the risk of occult ULMS after morcellation was 0.2% or 1 in 498 patients. [ 9 ] Rodriguez et al recently reported that the prevalence of occult ULMS in presumed morcellation cases was 0.14% or 1 in 714 patients. [ 10 ] Cao et al reported that the prevalence of occulted ULMS was 0.11% (29/26643) and that of morcellation was 0.02%.…”

Section: Discussionmentioning

confidence: 99%

Prevalence and occult rates of uterine leiomyosarcoma

Wang

Zhang³

et al. 2020

Medicine

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This study aimed to assess the prevalence and occult rates of uterine leiomyosarcoma (ULMS) in women with smooth-muscle tumors undergoing gynecological surgery. A retrospective study was performed at an academic cancer center from 2008 to 2015. Patients undergoing either hysterectomy or myomectomy via laparoscopic, abdominal, vaginal, and hysteroscopic approaches were identified with the validated pathology diagnosis of either ULMS or leiomyomas. All patients initially operated at our institute were included and reviewed. The prevalence and occult rates of ULMS were calculated and compared between different age groups. Twenty-eight patients with original ULMS were identified in 9556 gynecological surgeries. The prevalence of overall and occult ULMS in our study was 0.25% (1 in 345 patients) and 0.07% (1 in 1429 patients). The proportion of occult in all ULMSs was 25%. The prevalence rates of overall ULMS were 0.21%, 0.13%, 0.52%, 2.12%, and 6.67% in the 30 to 39, 40 to 49, 50 to 59, 60 to 69, and ≥70-year age groups, respectively. There was a significantly increased risk of ULMS after 50 years of age. The prevalence rates of occult ULMS were 0.05%, 0.08%, and 0.12% for the 30 to 39, 40 to 49, and 50 to 59 year age groups, respectively. There was no statistically significant difference among age the groups. The prevalence of ULMS was 0.41% and 0.16% for solitary and multiple tumor masses, respectively. Patients with solitary uterine tumors were at a significantly increased risk of ULMS (OR = 2.601, 95% CI = 1.108–6.141). Our retrospective data in part reflects the clinical characteristics of overall and occult ULMS and forms the basis for further prevention of occult ULMS.

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Section: Discussionmentioning

confidence: 99%

Prevalence and occult rates of uterine leiomyosarcoma

Wang

Zhang³

et al. 2020

Medicine

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“…The number of laparoscopic procedures has decreased in favor of laparotomy, since the Food and Drug Administrations (FDA) decided to discourage power morcellation [ 1 – 5 ] This decision was based on the occurrence of unexpected uterine (leiomyo)sarcoma during hysterectomy or myomectomy for presumed benign fibroids. It was calculated by the FDA that this risk is as high as 1 in 498 for uterine leiomyosarcoma (ULMS) [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Incidence and groups at risk for unexpected uterine leiomyosarcoma: a Dutch nationwide cohort study

Haak

Kroon

Warmerdam

et al. 2018

Arch Gynecol Obstet

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ObjectiveTo estimate the risk of uterine leiomyosarcoma in patients undergoing gynecological surgery and also to identify groups at risk for unrecognized uterine leiomyosarcoma.MethodsA national cohort study was performed evaluating all uterine leiomyosarcoma (ULMS) diagnosed in The Netherlands between January 2000 and September 2015. Cases were identified and supplied by the nationwide network and registry of histo- and cytopathology in The Netherlands (PALGA). Unexpected and expected ULMS were compared. Approval for this study was granted by the Medical Ethics Committee of all participating hospitals and by the review board of PALGA.Results262 original cases were included. The overall incidence of ULMS in our study was 0.25% or 1:400 patients. The incidence of unexpected ULMS was 0.12% or 1:865 patients. Preoperatively, a malignancy was unexpected in 46% of the cases and expected in 54%. Abnormal uterine bleeding constituted most of the symptoms. 90% of women underwent abdominal hysterectomy and/or bilateral salpingo-oophorectomy.ConclusionsLeiomyosarcoma are rare. Women aged 40–50 years with abnormal uterine bleeding are most at risk for unexpected ULMS. In contrast, this risk is low in postmenopausal women. ULMS were highly uncommon in women aged under 40 years.

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“…Analgesics: N (%) 18 (43.9) 52 (54.7) NS SD standard deviation, NS non-significant, HB hemoglobin, UTI urinary tract infection [18][19][20][21][22][23]. Morcellation was not used in the present study.…”

Section: Discussionmentioning

confidence: 99%