Due to the risk of possible carcinogenic and toxic effects, Philips Respironics has announced the recall of certain ventilators, BiPAP, and CPAP machines due to the polyester-based polyurethane sound abatement foam that is used to reduce sound and vibration in these affected devices.
What are CPAP, BiPAP, and Mechanical Ventilators?
Mechanical ventilators are used to assist patients to breathe by moving air into and out of the lungs with a fitted mask or breathing tube that goes into the patient’s lungs. These devices may also be used to provide short-term breathing support during an operation or when a patient has a critical illness.
CPAP and BiPAP machines are used to treat sleep apnea. Sleep apnea is a condition that causes an individual to repeatedly start and stop breathing during sleep. CPAP and BiPAP machines are also used to provide noninvasive breathing support for patients in respiratory distress or with neuromuscular weakness.
Philips Respironics Recalls Certain Ventilators, BiPAP, and CPAP Machines
Due to certain health risks including possible carcinogenic and toxic effects, Philips Respironics has recalled certain ventilators, BiPAP, and CPAP machines. The reason behind the recall is the polyester-based polyurethane (PE-PUR) sound abatement foam that is used to reduce sound and vibration in these affected devices. This foam may break down and potentially enter the device’s air pathway which may cause black debris from the foam or certain chemicals to be inhaled or swallowed by the person using the device. Ingestion or inhalation of these particles has been linked to the following effects:
- Toxic effects
- Respiratory issues
- Chemical exposure risk
- Carcinogenic effects
Philips Respironics has announced that they will replace the current sound abatement foam with new material. The FDA is reviewing this new information and will determine whether this proposed replacement device poses any risk to those who use the devices.
What does the FDA recommend regarding the Philips Respironics recall?
The FBA recommends that individuals who use an affected device may continue to use the device only if their health care provider determines that the benefits outweigh the risks that have been identified in the recall notification. The FDA has also provided information regarding alternative treatment options for obstructive sleep apnea for professional societies and patient advocacy groups.
The FDA has identified this as a Class I recall. A Class I recall is the most serious type of recall. The FDA is working with Philips Respironics to assure it has sufficient evidence to support the recall strategy which will include corrective actions. Philips Respironics is responsible for developing a recall strategy that will take into account the following factors:
- The degree to which the product’s deficiency is obvious to the consumer or user.
- The degree to which the product remains unused in the marketplace.
- Results of health hazard evaluation.
- Ease in identifying the product.
- The continued availability of essential products.
It is important to know that the FDA does not recommend that you remove the sound abatement foam from your affected device. This is due to the fact that this action may impact the device’s performance and may possibly introduce foam debris into the device.
The FDA will continue to monitor Philip Respironics’ recall.
If you have developed cancer or a serious health issue after using an affected device, it is important that you take legal action by contacting our defective medical devices law firm today to learn how we can assist you. Our knowledgeable legal team has experience representing victims of defective medical devices and is prepared to take on your case today. Do not hesitate to contact our firm if you have any further questions regarding this recall and the actions you may take regarding your damages.
CONTACT OUR EXPERIENCED TEXAS FIRM
Brock & Goetzmann has significant experience representing victims of defective medical devices in the Dallas-Fort Worth area. If you have been impacted in any way by a defective medical device, preserve the evidence and call us to investigate. Give our experienced Texas firm a call today to schedule your initial consultation.