The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Myoma Surgery

Po, Leslie; Lee, Patricia E.

doi:10.1016/j.jmig.2016.02.004

Cited by 7 publications

(2 citation statements)

References 18 publications

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“…The FDA's recommendation against the use of electric morcellation has resulted in several studies exploring the decisions that patients and surgeons have to make while considering the surgical treatment of uterine leiomyomas . In a recent survey of 669 gynecologic surgeons, Lum et al .…”

Section: Discussionmentioning

confidence: 99%

Temporal trends in minimally invasive myomectomy before and after the US Food and Drug Administration recommendation against electric morcellation

Pereira

Frankel

Hutchinson

et al. 2017

Intl J Gynecology & Obste

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Section: Discussionmentioning

confidence: 99%

Temporal trends in minimally invasive myomectomy before and after the US Food and Drug Administration recommendation against electric morcellation

Pereira

Frankel

Hutchinson

et al. 2017

Intl J Gynecology & Obste

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“…Most importantly from a patient perspective, a survey distributed to more than 300 women in gynecologic waiting rooms regarding the consequence of limiting access to MIS and limiting women’s choices indicated that at the 1 in 350 risk of a malignant tumor reported by the FDA, the majority of women would still choose an MIS approach …”

Section: Introductionmentioning

confidence: 99%

Practice Patterns and Complications of Benign Hysterectomy Following the FDA Statement Warning Against the Use of Power Morcellation

et al. 2018

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Major and minor 30-day complication rates among women undergoing hysterectomy for uterine fibroids increased following the FDA-issued statement. This increased risk corresponding with a decreased use of minimally invasive surgery should be balanced against the potential harms of morcellation during a shared decision-making process between clinician and patient. Regulatory bodies and medical societies should consider these findings when issuing relevant communications.

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Manual morcellation compared to power morcellation during robotic myomectomy

Sanderson

Cleason

et al. 2018

J Robotic Surg

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Clinical practice has drastically changed following the 2014 U.S. Food and Drug Administration (FDA) warning statement regarding power morcellation during laparoscopic hysterectomy and myomectomy. Despite investigation into alternative tissue extraction techniques, there remain a paucity of data associated with contained manual morcellation techniques. The goal of this study was to investigate the associated perioperative outcomes of contained manual morcellation compared to power morcellation in women undergoing robotic myomectomy. Performing manual morcellation (n = 38) resulted in a 21-min decrease in mean operative time (105.4 ± 42.2 vs 126.1 ± 44.1 min, p = 0.02) compared to power morcellation (n = 62). Women were younger (33 vs 36 years, p = 0.03) in the manual morcellation group, with all other patient demographics being similar. Median specimen weight (82 vs 104 g, p = 0.13), number of fibroids removed (2 vs 1, p = 0.16), estimated blood loss (10 vs 50 mL, p = 0.25), and post-operative morphine equivalents administered (5.57 ± 4.57 vs 5.29 ± 4.39, p = 0.76) were similar. The same-day discharge rate was not significantly different between the groups (86 vs 90%, p = 0.74). Linear regression modeling identified specimen weight, number of fibroids removed, and use of power morcellation as significant contributors to surgical time. Contained manual morcellation during robotic myomectomy is associated with a significant decrease in surgical time when compared to power morcellation, with similar post-operative narcotic administration and length of stay.

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The Unintended Consequences of an FDA Warning: The Case of Power Morcellation in Myoma Surgery

Cited by 7 publications

References 18 publications

Temporal trends in minimally invasive myomectomy before and after the US Food and Drug Administration recommendation against electric morcellation

Temporal trends in minimally invasive myomectomy before and after the US Food and Drug Administration recommendation against electric morcellation

Practice Patterns and Complications of Benign Hysterectomy Following the FDA Statement Warning Against the Use of Power Morcellation

Manual morcellation compared to power morcellation during robotic myomectomy

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