U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas

Parker, William H.; Kaunitz, Andrew M.; Pritts, Elizabeth A.; Olive, David L.; Chalas, Eva; Clarke‐Pearson, Daniel L.; Berek, Jonathan S.

doi:10.1097/aog.0000000000001157

Cited by 55 publications

(39 citation statements)

References 8 publications

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Section: Discussionmentioning

confidence: 99%

“…By addressing risk factors for malignancy and incorporating evolving surgical techniques into practice, gynecologists can continue to offer patients a minimally invasive approach for fibroid management [4,8,23]. Studies published since the 2014 Food and Drug Administration safety communications offer updated leiomyosarcoma incidence estimates [8,23,24]. Incorporating these studies suggests that mortality rates are low following hysterectomy for presumed benign fibroids overall, and a minimally invasive approach remains a safe option [8,23,24].…”

Section: Discussionmentioning

confidence: 99%

“…Gynecologic laparoscopic power morcellation (LPM) has come under increased scrutiny over the last 2 years due to widespread attention to a known but rare complication, an unanticipated dissemination of malignancy, namely occult uterine leiomyosarcoma [5][6][7]. Three years ago, the Food and Drug Administration in the United States of America (FDA) issued the alert on power morcellation for uterine leiomyomas, addressing the risk of malignant cell spreading within the abdominal cavity (actual risk assessment from 1 in 360 to 1 in 7400 cases) [8]. The US Food and Drug Administration (FDA) warned against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of leiomyomas because of the concern for inadvertent spread of tumor cells if an undiagnosed cancer were to be present.…”

Section: Introductionmentioning

confidence: 99%

“…The US Food and Drug Administration (FDA) warned against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for the treatment of leiomyomas because of the concern for inadvertent spread of tumor cells if an undiagnosed cancer were to be present. The authors, representing a 46-member review group, reviewed the current literature to formulate prevalence rates of leiomyosarcoma in women with presumed leiomyomas and to assess reliable data regarding patient survival after morcellation [8]. They disagree with the FDA's methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery [8].…”

Section: Introductionmentioning

confidence: 99%

“…The authors, representing a 46-member review group, reviewed the current literature to formulate prevalence rates of leiomyosarcoma in women with presumed leiomyomas and to assess reliable data regarding patient survival after morcellation [8]. They disagree with the FDA's methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery [8].…”

Section: Introductionmentioning

confidence: 99%

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

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Section: Introductionmentioning

confidence: 99%

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Is Laparoscopic Power Morcellation of Fibroids a Cardinal Sin in 2017?

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Needle tract seeding after percutaneous biopsy of sarcoma: Risk/benefit considerations

Berger-Richardson

Swallow

2016

Cancer

120

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To evaluate histologic subtype and grade, which in turn guide the decision making for multimodality therapy, the workup of suspected sarcoma requires more material than can be obtained from a fine-needle aspiration. Either open or percutaneous core needle biopsy is indicated before a management decision is made. Percutaneous biopsy of a potentially malignant lesion is controversial, given the perceived potential for tumor seeding along the needle tract. However, the evidence that the latter is a significant risk is weak at best. To the authors' knowledge, among cases of patients with extremity sarcoma who have undergone core needle biopsy, only a few cases of needle tract seeding have been reported to date. Although en bloc excision of the needle tract with the primary tumor is often performed, this practice is not associated with improved oncologic outcomes; the evidence for excision of the needle tract is poor. For patients with gastrointestinal stromal tumors, there is a theoretical risk of peritoneal dissemination after percutaneous biopsy, but to the authors' knowledge this remains unproven. Although endoscopic ultrasound is the preferred route for biopsy among patients with gastrointestinal stromal tumors, percutaneous biopsy is indicated if endoscopic ultrasound is unsuitable or unavailable. In the setting of retroperitoneal sarcoma, a review of pooled data from 4 large tertiary care referral centers demonstrated a risk of needle tract seeding of 0.37%. The authors concluded that the benefits of pretreatment biopsy in patients with mesenchymal tumors outweigh the potential risks of needle tract seeding. Cancer 2017;123:560-567. © 2016 American Cancer Society.

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