Objective In 2021 the U.S. FDA issued a Class 1 safety recall notice for specific devices due to a risk of carcinogen exposure. The objective of this study was to evaluate reports of cancer linked to CPAP devices to understand implications for the field of sleep medicine. Methods Cases of cancer involving CPAP devices were retrieved from the MAUDE database from 2014 to 2021 and analyzed with descriptive statistics. Results A total of 2571 patient injuries were associated with CPAP. Reports of cancer (n = 209; 4.62%) were the second most commonly documented patient problem associated with CPAP, although 1950 (43.13%) patients had a device problem without an associated injury. Of the 209 cancer cases associated with CPAP, 200 (95.7%) of the adverse event reports were received by the FDA in 2021. There were 174 (9.15%) descriptions of the CPAP polyurethane sound abatement foam degrading in association with a cancer diagnosis, but degradation was more commonly not associated with malignancy (n = 1728; 90.85%). Other frequently documented CPAP device problems included broken devices (n = 279; 6.92%), fire (n = 182; 4.51%), and patient–device incompatibility (n = 144; 3.57%). Conclusion Malignancy associated with CPAP devices has been reported; however, future studies are required to establish causation. Given 95.7% of those documented cases were reported in 2021, otolaryngologists should be prepared to discuss the risks of carcinogenesis associated with CPAP. The otolaryngology community should also be aware of the potential bandwagon effect and the implications for CPAP compliance. Level of Evidence 4 Laryngoscope, 132:2270–2274, 2022

ImportanceVagus nerve stimulation (VNS) devices have gained widespread acceptance for treatment of resistant epilepsy and depression. The increasing number of procedures has resulted in an increasing number of iatrogenic injuries to the vagus nerve, which can have a significant effect on vocalization and quality of life.ObjectiveTo determine the relative frequency of laryngeal adverse effects reported to the US Food and Drug Administration (FDA) after VNS implantation and to analyze associated VNS device problems.Design, Setting, and ParticipantsThis retrospective cross-sectional analysis queried the FDA Manufacturer and User Facility Device Experience database of adverse events in the US between 1996 and 2020.Main Outcomes and MeasuresThe primary outcome was the percent of adverse events reported to the FDA that included patients who received VNS with laryngeal adverse effects and the associated proportion of device problems after VNS surgery.ResultsA total of 12 725 iatrogenic vagus nerve issues were documented after VNS implantation, with apnea (n = 395; 3.1%) being the most common patient problem. Overall, 187 reports of laryngeal adverse effects associated with VNS devices were identified and represented the eighth most common iatrogenic vagus nerve problem reported to the FDA. Laryngeal adverse effects included 78 reports of voice alteration and 57 reports of paresis/paralysis. The VNS device problems frequently associated with laryngeal adverse effects were high impedance (n = 15, 8.02%), incorrect frequency delivery (n = 10, 5.35%), and battery problems (n = 11, 5.88%). The number of laryngeal adverse effect reports per year peaked in 2012 with 43 cases.Conclusions and RelevanceThis cross-sectional study found that although the literature demonstrates that vocal changes occur with nearly all VNS devices, the FDA receives adverse event reports of voice changes. Our results emphasize a potential need to improve patient counseling prior to VNS surgery to better set patient expectations regarding vocal changes and to prevent unnecessary patient concern. In addition, reports of vocal fold paresis/paralysis potentially suggest that patients may benefit from preoperative laryngeal assessment to differentiate preexisting vocal fold paralysis from that caused by VNS surgery.

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