title: Obstacles to Studying Emerging Technologies.
abstract: Laparoscopic radiofrequency ablation of uterine leiomyomas with a new Federal Drug Administration (FDA)-approved device, a device that delivers radiofrequency energy, is a novel procedure that aims to meet patient and physician demand for effective, minimally invasive leiomyoma treatment. However, as a new procedure, the durability of symptom relief, the safety in widespread use, and ultimately the comparative effectiveness of radiofrequency ablation of leiomyomas need further study. In June 2013, the University of California Fibroid Network, a collaboration of the five University of California Departments of Obstetrics and Gynecology, launched the Uterine Leiomyoma Treatment with Radiofrequency Ablation Study, an investigator-initiated early postmarket approval clinical trial of radiofrequency ablation of leiomyomas. In this commentary, we provide a review of the FDA approval process for medical devices using the device that delivers radiofrequency energy as a case study and describe significant limitations of this process that may adversely affect clinical care. We show how the deficiencies in the FDA process have challenged our ability to conduct independent early postmarket research evaluating the safety and long-term effectiveness of this novel technology. Our experience validates the Institute of Medicine's recommendation that advancements in surgical technology introducing new treatments without long-term effectiveness data, comparative study, or both should emerge onto the market under research conditions. Until the FDA requires more rigorous study of novel devices, we suggest ways of working together as a community of gynecologic surgeons to evaluate promising new technologies in early postmarket studies, putting research before widespread adoption of surgical innovation.
authors.affiliation: Departments of Obstetrics and Gynecology, University of California, Davis, School of Medicine, Sacramento, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, University of California Irvine, School of Medicine, Irvine, the Department of Reproductive Medicine, University of California, San Diego, School of Medicine, San Diego, and the Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, School of Medicine, San Francisco, California.
authors.forename: L Elaine
authors.initials: LE
authors.lastname: Waetjen
authors.forename: Ram
authors.initials: R
authors.lastname: Parvataneni
authors.forename: Shira
authors.initials: S
authors.lastname: Varon
authors.forename: Naghmeh Salamat
authors.initials: NS
authors.lastname: Saberi
authors.forename: Vanessa L
authors.initials: VL
authors.lastname: Jacoby
mesh_terms: D017115:Catheter Ablation / Q000295:instrumentation* / Q000379:methods; D018795:Device Approval / Q000592:standards; D004869:Equipment Safety / Q000379:methods / Q000592:standards; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000379:methods; D007889:Leiomyoma / Q000473:pathology / Q000601:surgery*; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation / Q000379:methods; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D013523:Surgical Equipment / Q000592:standards*; D014481:United States; D014594:Uterine Neoplasms / Q000473:pathology / Q000601:surgery*