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Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review
Olivia E Speed1, Anna Bareiss1, Vijay A Patel2
1Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
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.
Insights
Adverse events, including foreign body reactions, have been reported with porcine small intestine submucosal grafts (Biodesign™) in otologic surgery. These complications necessitate revision surgery and include hearing loss and facial paralysis.
Area of Science:
- Otolaryngology
- Biomaterials Science
- Surgical Safety
Background:
- Porcine small intestine submucosal grafts (Biodesign™) are utilized in otologic procedures for their availability and minimally invasive application.
- The graft's potential for foreign body reactions and associated complications requires thorough investigation.
Purpose of the Study:
- To review and summarize adverse events associated with Biodesign™ use in otologic surgery.
- To identify specific complications and their frequency.
Main Methods:
- A retrospective cross-sectional analysis of the FDA's MAUDE database was conducted.
- Medical device reports (MDRs) related to otologic Biodesign™ use from January 2016 to November 2022 were queried and reviewed.
Main Results:
- Five adverse events were reported for Biodesign™ in otologic surgery (tympanoplasty, stapes surgery).
- All events resulted in patient injury, requiring revision surgery, and included foreign body inflammatory reactions.
- Reported complications encompassed hearing loss, otalgia, persistent perforation, vertigo, and facial paralysis.
Conclusions:
- While Biodesign™ offers advantages in otologic surgery, foreign body or granulomatous reactions are documented risks.
- These potential complications should be carefully considered before utilizing this graft material in otologic procedures.
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