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FDA Issues HBOT Warning

Posted on in Food Poisoning

The U.S. Food and Drug Administration (FDA) has issued a warning to consumers about hyperbaric oxygen therapy (HBOT) and how some companies may be using deceptive advertising to promote HBOT.

With HBOT, a person breathes pure oxygen in a pressurized chamber or room. The air pressure in the room is increased up to triple the amounts higher than normal, allowing the lungs to take in almost three times the amount of oxygen they would be able to take in under normal pressure. The oxygen flows in the blood throughout the body, which helps healing.

Some of the treatments the FDA has approved are decompression sickness (one of the dangers associated with scuba diving), bubbles in blood vessels, infections, and hard to heal wounds (a common side-effect of diabetes and radiation treatments), carbon monoxide poisoning and embolism treatments.

The FDA's issued their warning because they say there are internet sites that claim HBOT is a safe and effective treatment for a myriad of diseases and conditions that have not been approved by the agency. The agency is concerned that consumers who believe that these devises have been approved for other, unapproved conditions could be putting themselves at risk. Nayan Patel, a biomedical engineer in FDA's Anesthesiology Devices Branch, said, “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. In doing so, they may experience a lack of improvement and/or worsening of their existing condition(s).”

The unapproved conditions that claim HBOT effectiveness include:

  • AIDS/HIV
  • Alzheimer's Disease
  • Asthma
  • Bell's Palsy
  • Brain Injury
  • Cerebral Palsy
  • Depression
  • Heart Disease
  • Hepatitis
  • Migraine
  • Multiple Sclerosis
  • Parkinson's Disease
  • Spinal Cord Injury
  • Sport's Injury
  • Stroke

The FDA has received almost 30 complaints from patients and medical professionals in the past three years about these unapproved treatment claims.

If you have been injured by the use of a defective medical devise, contact an experienced Illinois defective medical device attorney right away to find out what compensation you may be entitled to for pain and loss.

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