{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T09:28:37Z","timestamp":1791365317167,"version":"4.3.1"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2021,6,12]],"date-time":"2021-06-12T00:00:00Z","timestamp":1623456000000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,11,11]]},"abstract":"<jats:title>Summary<\/jats:title>\n               <jats:p>Magnetic sphincter augmentation using the LINX\u00ae device is a minimally invasive surgical option for patients with gastroesophageal reflux disease. An estimated 30,000 devices have been implanted worldwide. Device removals and erosion are identified risks. The objective of this analysis is to explore the procedure evolution with an emphasis on the removals and associated characteristics that may guide future clinical practice. The Manufacturer and User Facility Device Experience and Ethicon\u2019s complaint databases were queried for all surgical device explants since January 2013. Device unit sales were used to determine the rates. The endpoint was based upon the time from implant to explant. Explant and erosion rates were calculated at yearly intervals and the Kaplan-Meier estimator was used to measure the time to explant. Chi-square analyses were used to investigate the risk of explant associated with the size, geography and implant year. Overall, 7-year cumulative risk of removal was 4.81% (95% Confidence Interval (CI) CI: 4.31\u20135.36%). The likelihood of removal was significantly related to the device size (P &amp;lt; 0.0001), with smaller sizes being more likely to be explanted. The primary reasons for device removal and relative percentages were dysphagia\/odynophagia (47.9%), persistent gastroesophageal reflux disease (20.5%) and unknown\/other (11.2%). Overall, the 7-year cumulative risk of erosion was 0.28% (95% CI: 0.17\u20130.46%). The average device size increased from 14.2 beads \u00b1 1.0 in 2013 to 15.3 beads \u00b1 1.2 in 2019 (P &amp;lt; 0.001). Surgical technique and perioperative management play an important role in the outcomes. Clinical practice changes since magnetic sphincter augmentation has been incorporated into clinical use are associated with improved outcomes and should be further characterized. Smaller device size is associated with increased removal and erosion rates.<\/jats:p>","DOI":"10.1093\/dote\/doab036","type":"journal-article","created":{"date-parts":[[2021,6,12]],"date-time":"2021-06-12T05:48:11Z","timestamp":1623476891000},"source":"Crossref","is-referenced-by-count":28,"title":["Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation"],"prefix":"10.1093","volume":"34","author":[{"given":"Janet","family":"DeMarchi","sequence":"first","affiliation":[{"name":"Medical Affairs, Ethicon Incorporated, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Schwiers","sequence":"additional","affiliation":[{"name":"Biostatistics, Ethicon Incorporated, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Soberman","sequence":"additional","affiliation":[{"name":"Medical Safety, Ethicon Incorporated, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison","family":"Tokarski","sequence":"additional","affiliation":[{"name":"Clinical Affairs, Ethicon Incorporated, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,6,11]]},"reference":[{"issue":"10","key":"2021111717294956600_ref1","doi-asserted-by":"crossref","first-page":"2944","DOI":"10.1007\/s00464-012-2289-1","article-title":"The LINX\u00ae reflux management system: confirmed safety and efficacy now at 4 years","volume":"26","author":"Lipham","year":"2012","journal-title":"Surg Endosc"},{"issue":"4","key":"2021111717294956600_ref2","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1177\/1756283X13486311","article-title":"LINX\u00ae reflux management system in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux","volume":"6","author":"Bonavina","year":"2013","journal-title":"Therap Adv Gastroenterol"},{"issue":"8","key":"2021111717294956600_ref3","doi-asserted-by":"crossref","first-page":"719","DOI":"10.1056\/NEJMoa1205544","article-title":"Esophageal sphincter device for gastroesophageal reflux disease","volume":"368","author":"Ganz","year":"2013  21","journal-title":"N Engl J Med"},{"issue":"5","key":"2021111717294956600_ref4","doi-asserted-by":"crossref","first-page":"671","DOI":"10.1016\/j.cgh.2015.05.028","article-title":"Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux","volume":"14","author":"Ganz","year":"2016","journal-title":"Clin Gastroenterol Hepatol"},{"issue":"4","key":"2021111717294956600_ref5","doi-asserted-by":"crossref","first-page":"305","DOI":"10.1111\/dote.12199","article-title":"Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease","volume":"28","author":"Lipham","year":"2015","journal-title":"Dis Esophagus"},{"issue":"10","key":"2021111717294956600_ref6","doi-asserted-by":"crossref","first-page":"787","DOI":"10.1089\/lap.2015.0394","article-title":"Magnetic sphincter augmentation for gastroesophageal reflux at 5 Years: final results of a pilot study show long-term acid reduction and symptom improvement","volume":"25","author":"Saino","year":"2015","journal-title":"J Laparoendosc Adv Surg Tech A"},{"key":"2021111717294956600_ref7","volume-title":"Analysis of Incomplete Multivariate Data. 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