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An Analysis of the Food and Drug Administration Maude Database for Approved Devices in Obstetrics and Gynecology
Abstracts / Journal of Minimally Invasive Gynecology 26 (2019) S1−S97 Open Communications 23: Robotics (3:05 PM − 4:05 PM) 3:19 PM Surgical Management of Genitofemoral Neuralgia de Souza KM,*,1 Chapman H,2 McHenry A,2 Hibner M3. 1Obstetrics and Gynecology, Creighton University Arizona, Phoenix, AZ; 2Creighton University Arizona, Phoenix, AZ; 3OB/GYN, St Joseph’s Hospital and Medical Center, Phoenix, AZ *Corresponding author. Video Objective: This video reviews the etiology, diagnosis, and management of genitofemoral neuralgia which is defined as pain along the distribution of the genitofemoral nerve. Setting: The patient in this video began having symptoms of genitofemoral neuralgia following a laparotomy. A common mechanism of iatrogenic injury to this nerve is crush injury from poorly placed self-retaining retractors during abdominopelvic surgery. A neurectomy can be offered because the genitofemoral nerve has only sensory function and no motor function. Interventions: We review the surgical technique for resection of the genital branch of the genitofemoral nerve. This technique involves retroperitoneal dissection over the psoas muscle, identification of the bifurcation of the nerve into its femoral and genital branches, isolation of the nerve, resection of the nerve, and implantation of the proximal nerve ending into the psoas muscle for nerve regeneration and neuroma prevention. Conclusion: This technique is 66-100% in successful in relieving symptoms including the case of this patient.
Open Communications 23: Robotics (3:05 PM − 4:05 PM) 3:26 PM Robotic Resection of Abdominal Wall Endometriosis Delara RMM,* Behbehani S, Butler KA. Gynecology, Mayo Clinic, Phoenix, AZ *Corresponding author. Video Objective: To describe surgical techniques used to resect abdominal wall endometriosis. Setting: The patient is a 49 year old female who presents to a tertiary care academic institution with complaints of cyclic pelvic pain. Interventions: Minimally invasive excision of extrapelvic endometriosis. Conclusion: The goals of resection of abdominal wall endometriosis are restoration of normal anatomy and adequate excision of pathology in order to decrease risk of recurrence. Robotic excision of abdominal wall endometriosis is feasible with understanding of anatomy and mastery of basic surgical techniques.
Open Communications 23: Robotics (3:05 PM − 4:05 PM) 3:33 PM Efficient Myometrial Defect Closure in a Layer By Layer Fashion After Robot-Assisted Laparoscopic Adenomyomectomy: A Novel Technique Hijazi AO,1,* Al Sinan NA,1 Hwang H,2 Chung YJ,1 Kim MR1. 1 Department of Obstetrics and Gynecology, Seoul Saint Mary’s Hospital, The Catholic University of Korea, Seoul, Korea, Republic of (South); 2 Bucheon St.Mary’s Hospital, Bucheon, Korea, Republic of (South) *Corresponding author.
S83 Video Objective: Previous methods of myometrial defect closure were associated with an increased risk of uterine rupture due to incorrect alignment of uterine layers. We aim to present a technique which maintains adequate myometrial wall thickness, uterine layer alignment, and endometrial integrity. In this video we provide a detailed description of our novel technique for myometrial defect closure in robot-assisted laparoscopic surgery following adenomyomectomy. Setting: A forty-seven-year-old, single, female, who came to our tertiary university hospital with severe dysmenorrhea, not responding to medical therapy, and wishing to preserve her uterus. Interventions: After removal of the adenomyotic tissue, the myometrial defect is closed in three steps. First the defect between the anterior and posterior innermost myometrial layers is closed using a 2-0 Stratafix suture, 36 mm needle. Next, the two sides are approximated using a 2-0 PDS suture, 36 mm needle. Finally, the serosa is sutured in a baseball fashion using a 2-0 PDS suture, 26 mm needle in a baseball fashion. Conclusion: This technique was successful in greatly improving the patient’s symptoms. It also maintained the integrity of the endometrial cavity, posterior myometrial thickness and uterine layer alignment. Thus we believe this technique is feasible, and maybe the solution for adenomyosis in those seeking fertility preservation. Open Communications 23: Robotics (3:05 PM − 4:05 PM) 3:40 PM An Analysis of the Food and Drug Administration Maude Database for Approved Devices in Obstetrics and Gynecology Galhotra S,* Maurice JM. Rush University Medical Center, Chicago, IL *Corresponding author. Study Objective: To evaluate the accuracy of the postmarket surveillance process in the MAUDE database for devices approved via the Food and Drug Administration (FDA) premarket (PMA) and 510(k) approval processes and used in Obstetrics and Gynecology, comparing the accuracy of death and injury reports. Design: A retrospective observational study. Setting: Medical devices used in Obstetrics and Gynecology. Patients or Participants: Two hundred and nine product codes encompassing over 12,000 FDA approved devices. Interventions: n/a Measurements and Main Results: Death and injury reports were collected from November 1, 2002 to April 25, 2018 in the MAUDE database. This raw data was adjusted to improve accuracy. There was a total of 1,732 raw death reports of which 350 were attributed to the PMA process and 1,382 attributed to the 510(k) process. The adjusted death reports generated a total of 218 death reports of which 26 were attributed to PMA and 192 to 510(k). There was a total of 161,376 raw injury reports of which 36,033 were approved via PMA and 125,343 via 510(k). The adjusted injury reports generated a total of 2,254 reports, of which 440 were approved via PMA and 1,814 via 510(k). There was an 87% drop in number of adjusted death reports and a 98% drop in the number of adjusted injury reports as compared to raw data (p=.0015). Conclusion: Death reports in the MAUDE database are more accurate than injury reports, whether approved by the PMA or 510(k) process, and more likely to contain an actual death, as compared to actual injuries in injury reports. Raw death reports overestimated deaths 7.9 times as compared to adjusted death reports; injury reports overestimated total injuries by 71.9 times as compared to adjusted injury reports. The warrants a call for a more accurate a national device registry with concurrent robust statistical analysis so trends of potentially harmful devices can be identified.
Open Communications 23: Robotics (3:05 PM − 4:05 PM) 3:26 PM Robotic Resection of Abdominal Wall Endometriosis Delara RMM,* Behbehani S, Butler KA. Gynecology, Mayo Clinic, Phoenix, AZ *Corresponding author. Video Objective: To describe surgical techniques used to resect abdominal wall endometriosis. Setting: The patient is a 49 year old female who presents to a tertiary care academic institution with complaints of cyclic pelvic pain. Interventions: Minimally invasive excision of extrapelvic endometriosis. Conclusion: The goals of resection of abdominal wall endometriosis are restoration of normal anatomy and adequate excision of pathology in order to decrease risk of recurrence. Robotic excision of abdominal wall endometriosis is feasible with understanding of anatomy and mastery of basic surgical techniques.
Open Communications 23: Robotics (3:05 PM − 4:05 PM) 3:33 PM Efficient Myometrial Defect Closure in a Layer By Layer Fashion After Robot-Assisted Laparoscopic Adenomyomectomy: A Novel Technique Hijazi AO,1,* Al Sinan NA,1 Hwang H,2 Chung YJ,1 Kim MR1. 1 Department of Obstetrics and Gynecology, Seoul Saint Mary’s Hospital, The Catholic University of Korea, Seoul, Korea, Republic of (South); 2 Bucheon St.Mary’s Hospital, Bucheon, Korea, Republic of (South) *Corresponding author.
S83 Video Objective: Previous methods of myometrial defect closure were associated with an increased risk of uterine rupture due to incorrect alignment of uterine layers. We aim to present a technique which maintains adequate myometrial wall thickness, uterine layer alignment, and endometrial integrity. In this video we provide a detailed description of our novel technique for myometrial defect closure in robot-assisted laparoscopic surgery following adenomyomectomy. Setting: A forty-seven-year-old, single, female, who came to our tertiary university hospital with severe dysmenorrhea, not responding to medical therapy, and wishing to preserve her uterus. Interventions: After removal of the adenomyotic tissue, the myometrial defect is closed in three steps. First the defect between the anterior and posterior innermost myometrial layers is closed using a 2-0 Stratafix suture, 36 mm needle. Next, the two sides are approximated using a 2-0 PDS suture, 36 mm needle. Finally, the serosa is sutured in a baseball fashion using a 2-0 PDS suture, 26 mm needle in a baseball fashion. Conclusion: This technique was successful in greatly improving the patient’s symptoms. It also maintained the integrity of the endometrial cavity, posterior myometrial thickness and uterine layer alignment. Thus we believe this technique is feasible, and maybe the solution for adenomyosis in those seeking fertility preservation. Open Communications 23: Robotics (3:05 PM − 4:05 PM) 3:40 PM An Analysis of the Food and Drug Administration Maude Database for Approved Devices in Obstetrics and Gynecology Galhotra S,* Maurice JM. Rush University Medical Center, Chicago, IL *Corresponding author. Study Objective: To evaluate the accuracy of the postmarket surveillance process in the MAUDE database for devices approved via the Food and Drug Administration (FDA) premarket (PMA) and 510(k) approval processes and used in Obstetrics and Gynecology, comparing the accuracy of death and injury reports. Design: A retrospective observational study. Setting: Medical devices used in Obstetrics and Gynecology. Patients or Participants: Two hundred and nine product codes encompassing over 12,000 FDA approved devices. Interventions: n/a Measurements and Main Results: Death and injury reports were collected from November 1, 2002 to April 25, 2018 in the MAUDE database. This raw data was adjusted to improve accuracy. There was a total of 1,732 raw death reports of which 350 were attributed to the PMA process and 1,382 attributed to the 510(k) process. The adjusted death reports generated a total of 218 death reports of which 26 were attributed to PMA and 192 to 510(k). There was a total of 161,376 raw injury reports of which 36,033 were approved via PMA and 125,343 via 510(k). The adjusted injury reports generated a total of 2,254 reports, of which 440 were approved via PMA and 1,814 via 510(k). There was an 87% drop in number of adjusted death reports and a 98% drop in the number of adjusted injury reports as compared to raw data (p=.0015). Conclusion: Death reports in the MAUDE database are more accurate than injury reports, whether approved by the PMA or 510(k) process, and more likely to contain an actual death, as compared to actual injuries in injury reports. Raw death reports overestimated deaths 7.9 times as compared to adjusted death reports; injury reports overestimated total injuries by 71.9 times as compared to adjusted injury reports. The warrants a call for a more accurate a national device registry with concurrent robust statistical analysis so trends of potentially harmful devices can be identified.