title: The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience.
abstract: OBJECTIVE
  The objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP).
  
  
  METHODS
  US health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA.
  
  
  RESULTS
  Among 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal.
  
  
  CONCLUSIONS
  Events related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant.
  
  
  CONCLUSIONS
  This report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide.
authors.affiliation: Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States. Electronic address: mdcreinin@ucdavis.edu.
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Creinin
authors.affiliation: Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, FL, United States.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Kaunitz
authors.affiliation: Department of Obstetrics and Gynecology, University of California, San Francisco, CA, United States.
authors.forename: Philip D
authors.initials: PD
authors.lastname: Darney
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, United States.
authors.forename: Lisa
authors.initials: L
authors.lastname: Schwartz
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, United States.
authors.forename: Tonja
authors.initials: T
authors.lastname: Hampton
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, United States.
authors.forename: Keith
authors.initials: K
authors.lastname: Gordon
authors.affiliation: MSD BV, Oss, the Netherlands.
authors.forename: Hans
authors.initials: H
authors.lastname: Rekers
mesh_terms: D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D017135:Desogestrel / Q000008:administration & dosage*; D020878:Device Removal / Q000193:education; D004343:Drug Implants; D004345:Drug Industry; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000193:education*; D006282:Health Personnel / Q000193:education; D006801:Humans; D037141:Mandatory Programs; D011247:Pregnancy; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003271:Contraceptive Agents, Female; D004343:Drug Implants; C044815:etonogestrel; D017135:Desogestrel
keywords: Contraceptive implant; Etonogestrel; Monitoring; Training