Journal of minimally invasive gynecology
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J Minim Invasive Gynecol · Nov 2018
Observational StudyAssessment of Obstetric and Gynecologic Food and Drug Administration Device Approvals and Recalls.
To evaluate and compare the recall rates of obstetric and gynecologic devices approved via the Food and Drug Administration's 510(k) and premarket approval (PMA) processes. ⋯ The recall event rate for the 510(k) approval process is 13.6 times the rate for the PMA approval process for obstetric and gynecologic devices. Analysis of the results suggests improper device risk classification, inappropriate assignment of the approval process, increased device malfunctions, recalls by the 510(k) process and, therefore, increased risk to patients by these devices. This warrants a call for improvement and increased scrutiny in the 510(k) approval process for devices used in obstetrics and gynecology.
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J Minim Invasive Gynecol · Jul 2018
Case ReportsLaparoscopic Management of a Rudimentary Uterine Horn.
To demonstrate a technique of laparoscopic management of a rudimentary horn in a 12-year-old girl. ⋯ Laparoscopic management of a uterine rudimentary horn is feasible with satisfactory uterine reconstruction. This is not the first case of this surgery performed by laparoscopy. A similar case has been published in 2015 [1], and recently another video [2] has been published describing 2 other cases.
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J Minim Invasive Gynecol · Jul 2018
Surgical Outcomes of Paravaginal Repair After Robotic Sacrocolpopexy.
To evaluate surgical outcomes of robotic sacrocolpopexy with and without paravaginal repair for pelvic organ prolapse (POP). ⋯ In both groups, anatomic markers substantially improved within each group. There were significant differences in postoperative POP-Q findings, which may have been influenced by the fact that patients undergoing RPVR usually had worse baseline prolapse. This selection bias creates difficulty with interpretation. Although in this study RPVR did not change subjective outcomes, further study is necessary to control for the severity of prolapse.
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J Minim Invasive Gynecol · May 2018
Opioid Prescription and Patient Use After Gynecologic Procedures: A Survey of Patients and Providers.
To describe opioid distribution and patient use after gynecologic procedures. ⋯ With respect to the physician survey, we conclude there is a wide range of opioid prescription practices and patient opioid consumption after gynecologic surgery. The patient survey revealed that physicians prescribe fewer opioid tablets after a minimally invasive approach to hysterectomy versus open hysterectomy. However, most patients use less than half of prescribed opioids, and a fraction did not use any opioids at all.