Hysteroscopic Morcellation: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database

Haber, Karina; Hawkins, E.; Levie, M.; Chudnoff, S.

doi:10.1016/j.jmig.2014.08.008

Cited by 51 publications

(44 citation statements)

References 7 publications

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“…On the basis of the FDA's MAUDE (manufacturers and users device experience) database, hysteroscopic morcellators are associated with fewer life-threatening complications such as fluid overload, uterine perforation, and bleeding than is the case for RF resectoscopes. 89 These serious adverse events are addressed in their appropriate sections of this manuscript.…”

Section: Adverse Eventsmentioning

confidence: 99%

“…These devices were developed to further reduce adverse events that occur during traditional uterine resectoscopic surgery. 89,90 The first hysteroscopic electromechanical morcellator was the Truclear (Smith & Nephew, Andover, MA) system that was approved by the FDA in 2005. For optimal function, it is coupled with the high-flow Smith &Nephew fluid pump and media management device.…”

Section: Introductionmentioning

confidence: 99%

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Complications of Hysteroscopic and Uterine Resectoscopic Surgery

Munro

Christianson

2015

Clinical Obstetrics &Amp; Gynecology

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Adverse events associated with hysteroscopic procedures are generally rare, but, with increasing operative complexity, it is now apparent that they are experienced more often. There exists a spectrum of complications that relate to generic components of procedures, such as patient positioning, anesthesia, and analgesia, to a number that are specific to intraluminal endoscopic surgery that largely comprise perforation and injuries to surrounding structures and blood vessels. Whereas a number of endoscopic procedures require the use of distending media, the response of premenopausal women to excessive absorption of nonionic fluids used for hysteroscopy is somewhat unique, and deserves special attention on the part the surgeon. There is also an increasing awareness of uncommon but problematic sequelae related to the use of monopolar radiofrequency uterine resectoscopes that involve thermal injury to the vulva and vagina. Furthermore, the uterus that has previously undergone hysteroscopic surgery may behave in unusual ways, at least in premenopausal women who experience menstruation or who become pregnant. Fortunately, better understanding of the mechanisms involved in these adverse events, as well as the use or development of a number of innovative devices, have collectively provided the opportunity to perform hysteroscopic and resectoscopic surgery in a manner that minimizes risk to the patient.

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Section: Adverse Eventsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Complications of Hysteroscopic and Uterine Resectoscopic Surgery

Munro

Christianson

2015

Clinical Obstetrics &Amp; Gynecology

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“…2,3 Reports have suggested that IUM may be associated with adverse complications such as bowel damage, hysterectomy, uterine perforation, and pelvic infection, but an adverse event complication rate of <1% for hysteroscopic morcellation technique is lower than that for conventional electrocautery. 4 Other reports have suggested additional benefits such as reduction in instances of uterine perforation, cervical dilation, thermal bowel injury, and intrauterine adhesions when comparing the use of such a device with conventional methods. Operating time, fluid absorption, and the need for a second operation may also be reduced.…”

Section: Discussionmentioning

confidence: 99%

Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection

Lee

Matsuzono

2016

Hong Kong Med J

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“…Haber et al [38] reviewed data recorded on the manufacturer and user facility device experience (MAUDE) database and reported a complication rate of less than 0.1 %. The Food and Drug Administration (FDA) has been eager to clarify that the concerns relating to laparoscopic morcellation, in terms of dissemination of malignant tissue, do not apply to hysteroscopic morcellation.…”

Section: Hysteroscopic Morcellationmentioning

confidence: 99%

Endoscopic Treatment and Power Morcellation of Uterine Fibroids

Dixit

Jesner

Modarres

2016

Curr Obstet Gynecol Rep

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Although a variety of pharmacological and radiological treatment options are available, surgery in the form of myomectomy or hysterectomy provides a quick and effective relief of many symptoms, albeit with attendant surgical risks. In this article, we discuss endoscopic surgical treatments, their relative benefits, and their risks, including risk of morcellation. Patient selection and preoperative preparation for various surgical approaches is discussed. Overall, the evidence base for surgical treatments, including endoscopic, is weak, and, therefore, a pragmatic approach is outlined.

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Hysteroscopic Morcellation: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database

Cited by 51 publications

References 7 publications

Complications of Hysteroscopic and Uterine Resectoscopic Surgery

Complications of Hysteroscopic and Uterine Resectoscopic Surgery

Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection

Endoscopic Treatment and Power Morcellation of Uterine Fibroids

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