Implantable Silicone Medical Devices Prone to Cracking, Promoting Harmful Bacteria and Infections: Study
Some silicone devices had cracks and fractures, which could lead to infections, before they were even implanted in patients.
Tag Archives: Silicone
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High-Flow Nasal Cannula Therapy as Effective As CPAP for Pediatric Patients with Critical Respiratory Problems: Study
Researchers found HFNC was noninferior to CPAP treatment for pediatric patients with acute respiratory problems.
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More Than 21,000 Philips CPAP Problems Reported to FDA, Including 124 Deaths
Since a Philips CPAP recall was issued due to toxic sound abatement foam used in millions of sleep apnea machines, FDA has received widespread reports of respiratory problems, cancers, deaths and other side effects
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FDA Proposes Order to Require Philips Respironics Refund, Repair or Replace Recalled Sleep Apnea Machines
Federal regulators say Philips has failed to properly address recalled sleep apnea machines, leading to confusion among consumers and health concerns.
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Philips Recall of CPAP Machines Has Resulted in DOJ Investigation
Subpoena issued by federal law enforcement officials suggests a review is underway for problematic recall of Philips CPAP machines
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FDA Tells Consumers How to Get Their Philips CPAP Replacement Prioritized
Consumers can access an online patient portal to have their Philips CPAP Device's replacement prioritized, the FDA indicates
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Philips CPAP Recall Requires Aggressive Enforcement Action From FDA, Senator Says
Call to action comes after the FDA discovered some devices affected by the Philips CPAP recall were repaired with new sound abatement foam that may also place users' of the sleep apnea machines at risk.
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Repaired Philips CPAP Sleep Apnea Machines Have Been Returned to Customers with Potentially Unsafe Silicone Foam
FDA has ordered Philips to conduct independent testing of the silicone CPAP foam used to repair recalled sleep apnea machines
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Philips CPAP Recall May Have Been Incomplete and Probably Came Years Too Late, Per FDA Report
FDA inspectors found repeated failures to investigate or address reports that Philips CPAP foam degraded and released toxic chemicals
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Replacement Foam For Recalled Philips CPAP Devices May Have Problems of Its Own, FDA Warns
Inspection reveals Philips Respironics knew about sound abatement foam degradation problems as early as November 2015, and management took no corrective actions until April 2021
