BAD NEWS FOR CPAP USERS BUT VIVOS COULD BE THE TREATMENT THEY WERE HOPING FOR
Before the introduction the Vivos Therapeutic System, patients with sleep apnea disorder could only rely on CPAP machines to sleep better at night.
CPAP machines are safe devices, and their use is approved by the FDA. They do not remedy or cure sleep disorders, but they palliate the mechanical obstruction of the patient’s airways by ensuring continuous airflow to patients’ lungs.
There are however many problems with CPAP machines, and one of them is the absolute necessity to make sure the machine is cleaned up perfectly every morning, in order to avoid breathing bacteria, microbes and viruses left in the hose and mask by the simple action of breathing.
If users don’t clean their machine thoroughly and the hose and mask stay contaminated, they breathe viciated air and can develop serious infections such as:
Sinus infections
Respiratory infections
Allergic reactions
Pneumonitis
Pneumonia, and
Bronchitis
BAD NEWS FOR CPAP USERS
CPAP machines are a lifeline for patients affected by obstructive sleep apnea disorder. Without their CPAP, these patients would have not been able to receive any other relief from the disorder.
But there are really bad news for the users of a very well known CPAP machine manufacturer. In July 2021, Philips Respironics has just announced a recall of millions of CPAPs due to a serious manufacturing defect in one of the components of the machines.
EXTRACT FROM THE OFFICIAL PHILIPS RECALL NOTIFICATION
“On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.
Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.”
WHAT DOES THE FDA SAY?
“Philips Respironics has voluntarily recalled certain ventilators, BiPAP, and CPAP machines due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.”
Source: https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recall-frequently-asked-questions
WHAT DOES THIS MEAN FOR PATIENTS?
Obviously, people suffering from sleep apnea are extremely concerned: how long will they remain without their CPAP? What will be the cost of replacing their machine? Can they rent a CPAP while Philips fix their machine?
Veterans are a population of CPAP users that is particularly at risk: their health may be already be damaged by their former profession. Sleep apnea prevents people from sleeping normally, and therefore from repairing the body. Faced with the recall, these patients are extremely concerned.
The Veterans Administration has issued a communique, part of which we reproduce here: “While there is a potential risk from the deterioration of the sound abatement foam, those risks have to be balanced against the known health risks of untreated sleep apnea. VA clinical experts are working with the FDA and the manufacturer to understand those risks.”
Clearly, the VA is not the only medical body to advise their patients and their doctors to consider the balance of risks. This is a hard choice that every patient will have to make.
POTENTIAL LAWSUITS
According to the site of a Personal Injury Law Firm:
“The recalled CPAP machines from Philips have been found to emit defective sound abatement foam containing toxic particles or gases directly into the user’s airways. These toxic particles and gases can potentially lead to severe heath injuries including death.”
This news is confirmed on another Personal Injury Attorney website:
“On June 14, 2021, Philips Respironics announced a voluntary recall notification due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in their CPAP and BiPAP machines*.
- Sound abatement foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and
- The sound abatement foam may off-gas certain chemicals.
The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone sanitizing equipment, and certain environmental conditions involving high humidity and temperature.”
Clearly, personal injury attorneys are already jumping on the case, probably hoping to put together a class action lawsuit against Philips Respironics.
CPAP MODELS AFFECTED BY THE RECALL
According to Philips Respironics’ website, these are some of the machines affected by the recall:
Trilogy 200 Ventilator
Garbin Plus, Aeris, LifeVent Ventilator
(not marketed in US)
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A 40/30
A-Series BiPAP Hybrid A30
Also known as BiPAP Hybrid A30 Ventilator (A-Series)
(not marketed in US)
V30
Continuous Ventilator, Non-life Supporting
A 40/30
A-Series BiPAP A40
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
E30
Continuous Ventilator, Non-life Supporting
DreamStation ASV
SystemOne ASV4
Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced
C Series AVAPS/ST
OmniLab Advanced Plus
In-Lab Titration Device
IS THIS TIME FOR PATIENTS TO TURN TO OTHER SOLUTIONS?
Clearly, CPAPs only offer a palliative measure to a serious disorder affecting millions of people. Thy are not a cure. A patient with sleep apnea could only resigns themselves to staying on a CPAP for life, unless a real treatment would come to market.
This is the hope that the Vivos Therapeutic System may offer to a number of patients affected by mild-to-moderate obstructive sleep apnea.
VIVOS: A COMPLETELY DIFFERENT THERAPEUTIC APPROACH
The Vivos Therapeutic System adopts a completely different approach to the debilitating disorder, by gradually expanding underdeveloped upper and lower jaws, the root cause of many cases of obstructive sleep apnea.
Vivos is actually a treatment of mild-to-moderate obstructive sleep apnea, not just a palliative care protocol.
A Vivos-trained dentist custom designs the medical device for the patient’s mouth. The patient wears the device as directed by her/his doctor, mainly in the evening and during the night.
As the use of the device widens the patients’ jaws, their dentist will periodically readjust it to continue expanding the upper and lower jaws. A sleep specialist supervises the process.
The Vivos Therapeutic System is not a respirator. It does not involve the pushing of oxygenated air into the lungs. It is a medical device that applies mechanical pressure on jaws to unobstruct the patient’s airways.
Those patients that are good subjects for a Vivos System can expect to see results within weeks. This treatment is not forever. It usually takes 12 to 24 months to treat the obstruction, and then patients do not need the system anymore.