title: Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.
abstract: Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices.
authors.affiliation: Departments of Obstetrics and Gynecology, Radiology, and Dermatology, McGaw Medical Center of Northwestern University, the Feinberg School of Medicine of Northwestern University, and the Department of Radiology, University of Chicago Medical Center, Chicago, Illinois.
authors.forename: Jessica R
authors.initials: JR
authors.lastname: Walter
authors.forename: Emily
authors.initials: E
authors.lastname: Hayman
authors.forename: Shelun
authors.initials: S
authors.lastname: Tsai
authors.forename: Comeron W
authors.initials: CW
authors.lastname: Ghobadi
authors.forename: Shuai
authors.initials: S
authors.lastname: Xu
mesh_terms: D016208:Databases, Factual; D018795:Device Approval; D005260:Female; D006176:Gynecology; D006801:Humans; D009774:Obstetrics; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration