title: The Gastric Band That Is Not to Be : Efficacy, Safety and Performance of the Easyband™: a Multicenter Experience.
abstract: BACKGROUND
  Access port problems after laparoscopic adjustable gastric banding can be significant complications. The Easyband™ is an innovative type of gastric band, whose internal diameter can be adjusted by a telemetrically activated motor. The aim of this study was to evaluate safety, efficacy and performance of the Easyband™.
  
  
  METHODS
  A total of 110 morbidly obese patients were prospectively enrolled. The Easyband™ was implanted laparoscopically by experienced bariatric surgeons in six different hospital locations. Patient characteristics, surgery details, postoperative weight loss, and complications were recorded. Follow-up lasted 2 years.
  
  
  RESULTS
  Follow-up was completed by 78.2 % of the patients. Surgeons rated 71 % of each aspect of Easyband™ implantation as "easy" or "very easy". Adjustments were successful in 91 % of the attempts. One or more adverse events occurred in 79.1 % of the patients. Thirty-six serious adverse events were reported, of which 50 % was device-related. One or more functional tests failed in 20.9 % of the devices, 8.2 % passed after a repeated test. A reintervention was necessary in 15.5 % of the patients. Mean weight loss after 2 years was 24.2 ± 14.0 kg, mean excess weight loss was 46.1 ± 24 %.
  
  
  CONCLUSIONS
  Excess weight loss with the Easyband™ was comparable with other gastric banding devices. Adjustment of the device was simple, non-invasive and more acceptable to patients than with a standard access port. However, a high incidence of device-related problems requiring surgical explantation occurred. The Easyband™ represents a major advance in gastric band design, but significant technical problems need to be resolved before further implants can be recommended.
authors.affiliation: Department of Surgery, Atrium Medical Center Parkstad, Henri Dunantstraat 5, 6419 PC, Heerlen, The Netherlands. h.j.m.handgraaf@lumc.nl.
authors.forename: Henricus J M
authors.initials: HJ
authors.lastname: Handgraaf
authors.affiliation: Healthier Weight Centres, 22 Upper Wimpole Street, London, W1G 6NB, UK. david.ashton@healthierweight.co.uk.
authors.forename: David
authors.initials: D
authors.lastname: Ashton
authors.affiliation: Department of Surgery, San Bortolo Regional Hospital, Viale Ferdinando Rodolfi, 37, Vicenza, 36100, Italy. ffavretti@gmail.com.
authors.forename: Franco
authors.initials: F
authors.lastname: Favretti
authors.affiliation: Department of Surgery, San Bortolo Regional Hospital, Viale Ferdinando Rodolfi, 37, Vicenza, 36100, Italy. gsegat@tin.it.
authors.forename: Gianni
authors.initials: G
authors.lastname: Segato
authors.affiliation: Department of Surgery, St. Antonius Hospital, P.O. Box 2500, Nieuwegein, 3430EM, The Netherlands. b.ramshorst@antoniusziekenhuis.nl.
authors.forename: Bert
authors.initials: B
authors.lastname: van Ramshorst
authors.affiliation: Department of Surgery, Atrium Medical Center Parkstad, Henri Dunantstraat 5, 6419 PC, Heerlen, The Netherlands. b.meesters@atriummc.nl.
authors.forename: Berry
authors.initials: B
authors.lastname: Meesters
authors.affiliation: Department of Surgery, Atrium Medical Center Parkstad, Henri Dunantstraat 5, 6419 PC, Heerlen, The Netherlands. j.greve@ah.unimaas.nl.
authors.forename: Jan Willem M
authors.initials: JW
authors.lastname: Greve
mesh_terms: D000328:Adult; D020878:Device Removal / Q000009:adverse effects / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D015994:Incidence; D010535:Laparoscopy / Q000379:methods; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology; D016896:Treatment Outcome; D015431:Weight Loss
keywords: Adjustable gastric banding; Bariatric surgery; Laparoscopic adjustable banding; Morbid obesity; Weight loss