Sunday, February 21, 2010

Ear Candles: Risk of Serious Injuries - FDA Report

Years ago, when I had my yoga center, I use to do ear candling sessions.  I probably did over 500 in my practice and rarely did  saw an adverse reaction.  But yes, they did occur.  Not only did I see burns occur in the ear canal but wax dripped down into the ear and occluded the ear drum.  I personally experirenced burns in my ear drums after a session in early 2001.  My father had died and I had intense grief in my body - and later learned that the inner ear canal has many meridian points connected to the lung meridian.  Grief in the lungs in hot energy - and when it met the flame of the candle's fire it burned.  The only two clients that I saw that side effect had recently lost someone and were in an acute grieving state.  The cones I used were paraffin and linen.  They had no herbs or other substances - and they burned nicely.  I think that is why I saw so few side effects.  Another problem is that people try to cone themselves - or family members with no training. I went through a 2 day certifcation program with a lot of practice and the use of an otoscope throughout the procedure to assure we were cleaning the ears correctly.  Below is a report from the FDA warning consulers not to use ear candles.  I gave up ear candling years ago as a nurse because I could not find insurance to cover this holistic practice and knew of some of the side effects.  I decided not to put myself and my nursing license in a precarious situation due to these rare side effects.  What bothers me is that there are day to day serious adverse outcomes from medical devices used in healthcare and rarely does the FDA step in like this and prevent them from being used.  But - just thought those of you doing ear candling sessions should be aware of this recent announcement!

Ear Candles: Risk of Serious Injuries

Audience: Consumers, Otolaryngological healthcare professionals
FDA is notifying consumers and healthcare providers of its warning not to use ear candles - a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two - because they can cause serious injuries, even when used according to the manufacturer’s directions. According to advertised claims, a burning ear candle draws ear wax and “impurities” or “toxins” out of the ear canal. Other claims for ear candles include relief from sinus and ear infections, headache and earache, as well as improved hearing, “blood purification,” improvements in brain function, and cure cancer. FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits. FDA has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles.
FDA is especially concerned because some ear candles are being advertised for use in children. Children of any age, including babies, are likely at increased risk for injuries and complications if they are exposed to ear candles. Small children and infants may move during the use of the device, increasing the likelihood of wax burns and ear candle wax plugging up the ear canal. Also, their smaller ear canal size may make children more susceptible than adults to injuries.
Ear candles are sold and promoted in a variety of locations, including health food stores, flea markets, health spas and salons, as well as on commercial web sites.
Consumers and health care professionals are strongly encouraged to report injury related to the use of ear candles to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Online: www.fda.gov/MedWatch/report.htm
• Phone: 1-800-332-1088
• Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
• Fax: 1-800-FDA-0178

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