Fatalities possibly associated with hyaluronic acid injections: a review of events reported to the FDA

Abstract

Hyaluronic acid intraarticular injections are gel-like medical devices used in osteoarthritis. Patients may only experience modest improvement with these devices, which may be reclassified as medications in the United States (US). Medications may require more testing than devices, and device adverse event reporting in the US has come under scrutiny. We undertook an exploratory analysis of fatal adverse events for these injections in the US. We reviewed all adverse events reported to the US Manufacturer and User Facility Device Experience and Alternative Summary Reporting databases between 2014 and 2019 under the relevant product names and product codes. Reports assigned an outcome of “death” were retained, as were reports that were found to pertain to fatality after review. Of 3449 reports, 103 were found to pertain to 63 distinct fatalities. In 54 of these fatalities, the cause of death was stated to be unknown in narratives. We judged that eight fatalities may have had a logical nexus to device use; six of these fatalities were associated with infection. Low-quality information in reports suggests that the US should review its medical device adverse event reporting processes and providers who administer hyaluronic acid intraarticular injections should use meticulous aseptic technique.

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Correspondence to Ronald L. Carico Jr..

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This article was produced without funding from any source.

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The authors have no conflicts of interest to disclose.

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This article was produced using only publicly available data, collected using procedures outlined in the article. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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This article uses data that are made publicly available by US regulatory agencies. This study was reviewed by the institutional review board of Marshall University and deemed to be not human subjects research for the purposes of ethical review.

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Data were analyzed with Microsoft Excel. No custom code was necessary.

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RC was the primary author and was responsible for data collection and analysis. SA and CG provided technical and clinical feedback and assisted with manuscript revisions.

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Carico, R.L., Aspinall, S.L. & Good, C.B. Fatalities possibly associated with hyaluronic acid injections: a review of events reported to the FDA. Drugs Ther Perspect (2021). https://doi.org/10.1007/s40267-020-00804-z

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