Tuesday, September 21, 2010

Painful Side Effects Caused by Artimplant Artelon Spacer



The Artimplant Artelon Spacer is a medical device used for people with thumb disabilities.  The product is produced by Artimplant AB and distributed by Small Bone Innovations.  Neither company offers consumers a warning about the multiple reports of painful side effects and other negative, sometimes severe, reactions.

Artimplant Artelon Spacers are surgically implanted into a person’s hand with the intent to relieve arthritis but keep pinch strength intact.  The device itself is made of a mixture of biodegradable and non biodegradable materials.  The biodegradable part works as “scaffolding” in the patient’s hand.  It will take at least six years for the material to completely degrade, meanwhile tissue is supposed to regenerate in the hand. 

However, as is well known among medical professionals, when a foreign object is placed in the body, the body can reject it and react badly to the implanted device.  Many patients have reported serious reactions including loss of motion, swelling and inflammatory synovitis leading to incredible pain.  The Artelon Spacer can also break in the body.  Occasionally, under stress, it has fragmented leaving tiny pieces in the hand, which can cause pain.

The companies behind the Artelon Spacer did minimal investigation and research into the materials used in the device.  In fact, there was just one pilot study, which evaluated only 10 patients.  The study itself was biased, as it was funded by the industry. 


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