Abstract

conducted at seven U.S. sites implants (Dec. 2007 t0 May 2008), and study II included 576 participants at 16 US sites (Aug, 2009 to March, 2011). All were private practices with only 1 practice participating in both studies. At the time of closing out data collection, trial I was complete and 5-year data on all participants available; and for trial II, all had completed 3 years, so only data to 3 years was included. Explants were defined as removing the LB without simultaneous replacement. Results: Yearly explant numbers and rates are presented for both studies for 3 years and study I for years 4 and 5. (See Table) ** Of the 9 in year 5, 7 were from one practice where patients were offered free removal of the LB at the end of the study. All 7 were performed in relation to the study end and several of these in the months following study closure but were planned within the study period. Conclusions: Explant rates in both studies are similar and much lower than the 32.5% safety signal at 5 years. This report reflects the literature from practices using LAGB surgery and mirror the change with time reported in these practices. There have been changes in band design, placement technique and adjustment practices, all of which may have contributed to the major fall in LB explants. UPLOAD-203147-_Laparoscopic adjustable gastric band explanation rates have varied greatly in the literature.pdf

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