Voluntary Recall Information


Philips Respironics Sleep and Respiratory Care devices

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News and Updates > External studies summary of the risk of cancer for Philips Respironics users was not higher compared to other brands

External studies summary of the risk of cancer for Philips Respironics users was not higher compared to other brands

August 11, 2022

In June 2021, Philips Respironics issued a voluntary recall notification for specific CPAP and BiPAP devices due to an issue related to the polyester-based polyurethane (PE-PUR) foam that is used to decrease the sound within the devices. The foam may degrade into particles that might enter the device and then possibly be ingested or inhaled. It had been originally thought that volatile organic compounds (VOCs) may have been emitted, which after additional testing has been found to not deliver harm.


Healthcare providers have been reviewing their patient data bases to determine if anyone who had  used a Philips Respironics PAP device have increased health issues, including cancer. Analysis from Canada1 and France2 that included about 13,000 patients, compared the incidence of cancer in those that were treated with a PE-PUR foam device versus a non-PE-PUR foam device. In these two publications, the risk of cancer for Philips Respironics users was not higher compared to other brands.


As part of our commitment to supporting our patients and sharing further detail and clarity on the latest research and analysis, below we have provided a brief summary of each of these studies:

An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? A Secondary Data Analysis

Tetyana Kendzerskam MD., et al, Journal of Respiratory Critical Care Medicine

Dr. Tetyana Kendzerska and colleagues did not find a higher risk of incident cancer among patients with obstructive sleep apnea (OSA) who had a Philips Respironics CPAP device compared to those who had devices from other manufacturers. The researchers used data from 6,903 patients in the province of Ontario who purchased a positive airway pressure device since 2012 and who were free of cancer at the start of OSA treatment. Over an average follow-up of 7.5 years, 5.4% of patients developed cancer. There were no significant differences in incident cancer between different PAP device manufacturers, including ResMed and Fisher&Paykel, compared to Philips Respironics.1

Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea

Gregoire Justeau, MD., et al, European Respiratory Journal

In the study from France, Dr. Gregoire Justeau and associates reported that sustained CPAP therapy of OSA using Philips Respironics devices containing PE-PUR foam, was not associated with an increased risk of cancer after an average follow-up time of 7.2 years. The group analyzed data from 4,447 patients who had not been diagnosed with cancer at the time of their sleep study or within 1 year afterwards. Using Philips Respironics devices was not associated with all-cancer frequency compared to using devices from other manufacturers. Additionally, the use of Philips Respironics devices was not associated with new cases of lung cancer.2

There are 11 other studies that provide minimal additional insights, but show there is no increased risk of cancer when using a CPAP device.3-13

 

Philips Respironics is committed to further testing and reporting as we work through the repair and replacement program for affected CPAP, BiPAP and mechanical ventilator devices. 


The overall guidance for healthcare providers and patients in the recall notification/field safety notice* remains unchanged at this time.


To learn more about voluntary recall/field safety notification, you can find information at philips.com/src-update.

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References

1. Kendzerska, T. et al, An Association between Positive Airway Pressure Device Manufacturer and Incidence Cancer? A Secondary Data Analysis, Letter to the Editor, AJRCCM, Vol 204, No 12, Dec 15, 2021
2. Justeau g, Gerves-Pinauie C, Jouvenot M, et al, Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea. EUR Respir J 2022; in press (https://doi.org/10.1183/13993003.00551-2022).
3. Cheng H, Li D. Investigation into the association between obstructive sleep apnea and incidence of all-type cancers: a systematic review and meta-analysis. Sleep Med 2021;88:274-281 
4. Cheng L, Guo H, Zhang Z, Yao Y, Yao Q. Obstructive sleep apnea and incidence of malignant tumors: a meta-analysis. Sleep Med 2021;84:195-204 
5. Gozal D, Almendros I, Phipps AI, et al. Sleep apnoea adverse effects on cancer: true, false, or too many confounders? Int J Mol Sci 2020;21(22) 
6. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. PLoS Med 2021;18:e1003583 
7. Balshem H, Helfand M, Schunemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011;64:401-406  
8. Justeau G, Bailly S, Gervès-Pinquié C, et al. Cancer risk in patients with sleep apnoea following adherent 5-year CPAP therapy. Eur Respir J 2021. 
9. Nieto FJ, Peppard PE, Young T, Finn L, Hla KM, Farré R. Sleep-disordered breathing and cancer mortality: results from the Wisconsin Sleep Cohort Study. Am J Respir Crit Care Med 2012;186:190- 194. 
10. Martínez-García MA, Campos-Rodriguez F, Durán-Cantolla J, et al. Obstructive sleep apnea is associated with cancer mortality in younger patients. Sleep Med 2014;15:742-748. 
11. Sillah A, Watson NF, Gozal D, Phipps AI. Obstructive sleep apnea severity and subsequent risk for cancer incidence. Prev Med Rep 2019;15:100886. 
12. Kendzerska T, Leung RS, Hawker G, Tomlinson G, Gershon AS. Obstructive sleep apnea and the prevalence and incidence of cancer. CMAJ 2014;186:985-992. 
13. Kendzerska T, Povitz M, Leung RS, et al. Obstructive Sleep Apnea and Incident Cancer: A Large Retrospective Multicenter Clinical Cohort Study. Cancer Epidemiol Biomarkers Prev 2021;30:295- 304.  

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