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Although the Artimplant Artelon® Spacer medical device is known to cause extremely painful side effects in some, Artimplant and Small Bone Innovations, Inc. still produce and distribute it without warning to unsuspecting patients looking for relief from osteoarthritis. The Locks Law Firm is happy to discuss your legal rights with you if you believe you have suffered because of the Artelon® Spacer. Our attorneys, located in New Jersey, New York, and Pennsylvania, have many years of experience litigating defective medical device lawsuits. Please contact our firm to schedule an appointment to discuss your potential claim.
The Artimplant Artelon® CMC Spacer is a medical device marketed to those with thumb disabilities. The thumb pain can be due to trapeziometacarpal (TM) or basal joint osteoarthritis in the thumb joint. The spacer is a device shaped like a capital T that is surgically implanted into the hand. The device is designed to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal, or the thumb and wrist joint. Approximately 11,000 Artelon® Spacers have been implanted in patients worldwide.
The Artelon® Spacer is constructed of two different materials, one which is biodegradable and one which is not. The biodegradable component, ε-polycaprolactone, is a fiber-based polyester, which is designed to slowly dissolve in the presence of water within the user. The degradation takes place over a period of six years. The intention is that the degradable component will serve as "scaffolding" while the patient's own tissue regenerates. The polyurethane acts to resurface the trapezium and stabilize the joint by augmenting the joint capsule. The goal is to reduce arthritic pain in patients while preserving pinch strength.
Unfortunately for the people seeking relief from this device, there have been many reports where the product has failed to perform. It is well known within the medical community that any time an artificial material is placed within the body, it can create a foreign body reaction. Even though part of the device is designed to decompose within the hand without causing problems, some people have experienced significant adverse reactions. Giant cell reactions to the foreign materials have lead to inflammatory synovitis with incredible pain, swelling, loss of motion, and need for additional surgery.
If you've experienced any of these symptoms after implantation of the Artelon® Spacer, please contact the attorneys of Locks Law Firm today. Our Pennsylvania, New Jersey, and New York offices are currently accepting cases from all 50 states.
The materials that comprise the Artelon® Spacer can be inert in some situations. However, the Artelon® Spacer experiences compressive and shearing loads when implanted in the thumb joint, which can cause small pieces of the device to break off into the body. The device can literally fragment under stress. It might be these small bits of foreign matter within the hand which cause a foreign body reaction and subsequent pain for the user.
The Swedish manufacturer, Artimplant AB and the US distributor, Small Bone Innovations, have performed very little scientific research to investigate whether or not the biodegradable material found within their Artelon® Spacer is safe for use in humans. There has been only one single controlled prospective pilot study in the literature reporting the results of this Artelon® joint spacer, and this study only evaluated 10 patients who had been implanted with the device. The study was not even conducted by an unbiased researcher; it was paid for by the industry.
Locks Law Firm wants to help those who have been harmed by an Artelon® Spacer. The attorneys in our Philadelphia, New Jersey, and New York offices are currently investigating nationwide cases against the Artelon® Spacer manufacturer, Artimplant, and the distributor, Small Bone Innovations, for defective design of a medical device and failure to warn patients. If you have suffered negative side effects after using an Artelon® Spacer to treat osteoarthritis, our attorneys would be happy to discuss your legal rights with you. We can help you pursue financial compensation for medical bills, lost wages, and pain and suffering.
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