Evidence map›Paper›PMID 26646134›Full record

ArticleObstetrics and gynecology2016

U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?

William H Parker, Andrew M Kaunitz, Elizabeth A Pritts, David L Olive, Eva Chalas, Daniel L Clarke-Pearson, Jonathan S Berek, Leiomyoma Morcellation Review Group

Abstract read
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In one paragraph

Article in Obstetrics and gynecology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
11.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 56 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Frequency of uterine sarcomas in patients admitted for uterine fibroid surgery.Journal of the Turkish German Gynecological Association · 2017
    Article
  11. Is Laparoscopic Power Morcellation of Fibroids a Cardinal Sin in 2017?Journal of obstetrics and gynaecology of India · 2017
    Article
  12. Review
  13. Review
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

William H ParkerUCLA School of Medicine, Los Angeles, California; the University of Florida College of Medicine, Jacksonville, Jacksonville, Florida; the Wisconsin Fertility Institute, Middleton, Wisconsin; Winthrop-University Hospital, Mineola, New York; the University of North Carolina, Chapel Hill, North Carolina; and Stanford University School of Medicine, Stanford, California.
Andrew M Kaunitz
Elizabeth A Pritts
David L Olive
Eva Chalas
Daniel L Clarke-Pearson
Jonathan S Berek
Leiomyoma Morcellation Review Group
Jacksonville University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The U.S. Food and Drug Administration (FDA) is warning 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 present. The authors, representing a 45-member review group, reviewed the current literature to formulate prevalence rates of leiomyosarcoma in women with presumed leiomyomas and to asses reliable data regarding patient survival after morcellation. The authors disagree with the FDA's methodology in reaching their conclusion and provide clinical recommendations for care of women with leiomyomas who are planning surgery.

Indexed as

Neoplasm SeedingPractice Guidelines as TopicFemaleHumansHysterectomyLeiomyomaLeiomyosarcomaMorcellationUnited StatesUnited States Food and Drug AdministrationUterine MyomectomyUterine Neoplasms

Identifiers

PMID26646134
OpenAlexW2326122919

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.