Hyperbaric oxygen chambers can be used to treat diabetic foot ulcers, and the government is fine with that. But regulators are becoming increasingly concerned about other benefits that are being ascribed to these devices.
The Food & Drug Administration recently sent out five warning letters and issued a consumer alert stating that no clinical basis exists for many of the claims being made.
“Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by FDA, which may cause them to delay or forgo proven medical therapies,” said Nayan Patel, a biomedical engineer in FDA’s Anesthesiology Devices Branch. In doing so, patients may experience worsening of their condition, he said.
Patients may be unaware that the safety and effectiveness of HBOT has not been established for many diseases and conditions, including Alzheimer’s disease, asthma, brain injury, depression, heart disease and stroke, he said.
The FDA has received 27 complaints over the past three years about treatment centers promoting the hyperbaric chamber for non-approved uses. Additionally, patients receiving hyperbaric oxygen therapy face other risks, such as ear pressure and sinus pain, as well as a risk for paralysis.