Title: removing the magnetic sphincter augmentation device: operative management and outcomes authors: james m.Tatum, evan alicuben, nikolai bildzukewicz, kamran samakar, caitlin c.Houghton, john c.Lipham citation cite: surgical endoscopy (2019) 33:2663¿2669 https://doi.Org/10.1007/s00464-018-6544-y this is a retrospective review of patients undergoing msa removal from march 2009 to september 2017 in a single institution.Reason for removal, operative management, and short-term outcomes are reported.During the study, 435 msa devices were implanted all patients who underwent msa with the linx reflux management system (torax® medical, inc.Reported complications included dysphagia (n=9) , recurrent or persistent gerd (n=13) , secondary to erosion (n=2) and hiatal hernia (n=9) in conclusion msa removal when necessary can be accomplished through minimally invasive means.Repeat linx or fundoplication can be performed after removal, however may not be necessary in patients with removal for dysphagia.
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(b)(4).Date sent: 6/21/2023 this report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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