A concerning article* was recently shared by NPR** in October (written by The Associated Press). As a neuromuscular dentist who treats a number of sleep apnea patients through oral appliance therapy, it provides an update on an issue I’ve been tracking for quite some time.
First, let me address the crux of the issue…
Sleep apnea sufferers experience pauses in breathing during sleep, some lasting up to a minute. These breathing halts, for some people, can occur hundreds of times per night. The deprivation of sufficient oxygen to the body can result in a long list of health issues, some severe and even deadly. These include heart attacks, stroke, being more accident prone and weight gain.
A CPAP device is often recommended to help sleep apnea patients achieve sufficient airflow during sleep. This consists of a mask worn over the nose and mouth, a hose, and a device that forces air into the hose to overcome the potential health repercussions of inadequate air intake during sleep.
For those who have been prescribed a CPAP device, some have difficulty with compliance, especially on a nightly basis. Common complaints are the noise, feeling claustrophobic, inconvenience when traveling, and even embarrassment.
For those who have sleep apnea, a custom-made oral appliance allows us to provide an alternative. These small, comfortable, FDA approved oral inserts reposition the lower jaw just slightly so air intake is easier and more efficient.
However, for those who are dependent on CPAP, the recall of a particular name brand has become an issue that has lagged on for over two years now. It is predicted to continue for another year, yet with no resolution for those left holding the previously-purchased product.
According to the article, sleep apnea machine manufacturer Philips announced in June 2021 that a foam in the device was able to break down. This could lead to particle inhalation and breathing in chemicals throughout the night. Users were reporting persistent sinus infections and pneumonia.
The Food and Drug Administration found that specific models were causing risks to users that included asthma, allergic reactions and cancer-causing effects on internal organs and headaches. To replace the faulty device, patients were facing an investment of $500 – 1000, with no guarantee of reimbursement for the recalled devices.
The involvement recently of the FDA (after nearly 70,000 complaints) was necessitated by the slow reaction of Philips to correct and replace the devices on a timely basis. Because the health risks of sleep apnea are so significant, many users are being told to continue using their CPAP despite the risks. However, patience is wearing thin.
The FDA has issued court orders to speed up the process. For CPAP users, it is coming to light that the problem was made aware to Philips as early as 2015, with no corrective action taken until 2021. The lack of response or sense of urgency to replace these devices has prompted some CPAP users to pursue the alternative of sleep apnea oral appliances.
In our Shelby Township dental office, we offer oral appliances to restore sufficient air flow during sleep without the bulk, noise, confinement and awkwardness of CPAP devices.
According to the American Academy of Dental Sleep Medicine, “Oral appliance therapy is an effective treatment option for snoring and obstructive sleep apnea (OSA). A custom-fit oral sleep appliance can improve your sleep, restore your alertness and revitalize your health.” (https://aadsm.org/oral_appliance_therapy.php)
As a highly-trained Neuromuscular dentist, I have a unique understanding that goes far beyond dental structures. In addressing heavy snoring or sleep apnea, these skills provide our patients with optimal comfort and exceptional results. By combining these advanced skills with some of the most advanced technology available, we are able to pinpoint precise areas of airway passage interference.
Throughout Macomb County and beyond, effective devices for sleep apnea and snoring are designed for each individual with the help of Cone Beam 3D imaging. In one pass around the patient, this highly-advanced technology captures clear, concise views of airway passages at the lowest radiation levels possible.
In our Shelby Twp dental office, we have had excellent success working with patients who have been diagnosed with sleep apnea. Begin with a free, no obligation consultation to have your questions answered thoroughly. Call 586-739-2155 or tap here to begin. You may also wish to complete a brief Sleep Questionnaire at: SleepQuestions
Learn more about our advanced technology at: DrBarbatAdvancedTechnology
And, check out our web site’s Sleep Apnea section at: DrBarbatSleepApnea as well as our entire dental office through: WhereLastingSmilesBegin.com
* To read the article in its entirety, go to: https://www.npr.org/2022/10/25/1131380992/phillips-cpap-recall-sleep-apnea-foam-particles
** NPR “is an independent, nonprofit media organization that was founded on a mission to create a more informed public.” (As stated on the NPR web site: https://www.npr.org/about/)
