Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review.

Autor: Speed OE; Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Bareiss A; Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Patel VA; Department of Otolaryngology - Head and Neck Surgery, University of California San Diego, La Jolla, CA, USA; Division of Pediatric Otolaryngology, Rady Children's Hospital - San Diego, San Diego, CA, USA., Mangan A; Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Dornhoffer J; Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA; Department of Otolaryngology - Head and Neck Surgery, Arkansas Children's Hospital, Little Rock, AR, USA., Saadi RA; Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA; Department of Otolaryngology - Head and Neck Surgery, Arkansas Children's Hospital, Little Rock, AR, USA. Electronic address: rsaadi@uams.edu.
Jazyk: angličtina
Zdroj: American journal of otolaryngology [Am J Otolaryngol] 2023 Sep-Oct; Vol. 44 (5), pp. 103961. Date of Electronic Publication: 2023 Jun 15.
DOI: 10.1016/j.amjoto.2023.103961
Abstrakt: Objective: To review and summarize reported adverse events related to the use of porcine small intestine submucosal grafts (Biodesign™) in otologic procedures.
Study Design: Retrospective cross-sectional analysis.
Setting: Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.
Material and Methods: The MAUDE database was queried for all medical device reports (MDR) related to otologic use of Biodesign™ (Cook Medical, Bloomington, IN) from January 2016 to November 2022. Adverse events (AEs) were identified by reviewing all reports with the basic search term "Biodesign" and "Biodesign, Otologic". Reports were individually reviewed and categorized with special attention to AEs.
Results: A total of 500 reports were reviewed. Since FDA approval of Biodesign™ in 2016, there have been 5 adverse events reported for use of Biodesign™ during otologic surgery (tympanoplasty, n = 3; stapes surgery, n = 2). All reported events described patient injury, and all cases required at least one revision surgery. Four cases described significant foreign body inflammatory reactions. Complications included hearing loss (n = 3), severe otalgia (n = 2), persistent perforation (n = 2), vertigo (n = 2), and facial paralysis (n = 1).
Conclusion: The use of porcine small intestinal submucosal graft has been thought to be a safe and effective option for otologic surgery, with the advantage of availability without graft harvest in minimally invasive endoscopic surgery. However, foreign body or granulomatous reactions have been documented and should be considered prior to its use in otologic surgery.
Competing Interests: Declaration of competing interest There are no relevant conflicts of interest from any authors.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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