The U.S. Food and Drug Administration recently recalled two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. The recall was a Class 1, which means there is a reasonable probability that the use of a device will cause adverse reactions, including death.
The U.S. Food and Drug Administration recently recalled two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions.
The recall was a Class 1, which means there is a reasonable probability that the use of a device will cause adverse reactions, including death. The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. The FDA said that based upon the original health claims made by the company, patients may forgo approved therapies, resulting in more severe illness or death. “These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices,” said Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health.
“One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.”
On April 11, the FDA issued a warning letter to VIBE Technologies stating that the agency's November 2007 inspection of the facility showed that the company had not obtained FDA marketing approval or clearance for the Vibrational Integrated Bio-photonic Energizer (VIBE device), which claims to treat cancer, infections, and depression. The FDA also cited the company for substantial deviations from the current Good Manufacturing Practice/Quality System regulation.
VIBE Technologies recalled the 840 VIBE devices in an April 3 letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions. The FDA is aware of information that suggests that the VIBE device has been used in cancer patients.
The death of one patient who used this device has occurred. However, FDA has not verified that there is any association between the death and the VIBE device. An FDA inspection of Nebion LLC in June revealed that the company had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation. Nebion recalled eight HLX8 devices on July 2, telling its customers to stop using the devices immediately and to contact Nebion for retrieval.
Nebion's first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that it will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.
Under federal law, products that claim to diagnose a disease or condition, or cure, mitigate, treat or prevent disease, or that are intended to affect the structure or function of the body are devices subject to FDA jurisdiction and may require FDA approval or clearance prior to marketing. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. FDA clearance is for lower-risk devices that are shown to be as safe and effective as a similar device already on the market. Neither VIBE Technologies nor Nebion has demonstrated to the FDA that their device is safe and effective at curing or treating diseases as claimed.