AUSTIN (KXAN) — Thousands of people every day struggle to breathe while they sleep, but there are devices to help.
Ventilators, CPAP and BiPAP machines are the answer according to experts, but one company’s devices are being recalled. The FDA is recalling Philips Respironics ventilators, BiPAP and CPAP machines.
The Food and Drug Administration is pulling millions of devices off the market without telling users what to do instead.
To make matters worse, an FDA investigation found that the company behind them may have known about these potential hazards for years.
The recall focuses on a foam that’s used to reduce noise and vibration.
It says the foam can fall apart and potentially release debris or chemicals into the tube users breathe in.
That can injure someone or even cause cancer.
The FDA’s recent investigation found warnings from inside the company about potential hazards. It looked at least 14 tests some date back to early 2016. The investigation says staff was, “aware of issues and concerns related to potential foam degradation,” but ultimately nothing was done to change the device’s design.
Since the FDA issued the initial voluntary recall back in June, Philips has begun replacing and repairing machines, but the FDA warns that the new silicone-based foam could also be hazardous.
The FDA said it does not have enough information right now to recommend people stop using the new devices. So what should people do? It’s not easy to just get a new one.
Experts we talked to say not having these machines or using it could lead to more health problems.
“In people who have severe sleep apnea they have a 300%, increase in likely having a stroke, 300% increase in having a heart attack and memory loss which becomes substantial,” said Dr. Raymond Perkins, a sleep specialist at Baylor Scott & White.
Martha Mahan reached out to KXAN to tell us about her concerns. She’s still looking for an alternative.
She says before she started using a CPAP machine she felt forgetful and tired. She says the machine improved her quality of life, but when she heard about the recall she stopped using it.
“I feel that I am not getting the oxygen in my body, in my heart in my mind,” Martha said. “So, that is probably going to bring my body down. When I already felt 100% better. I don’t think it is fair.