What is the Artelon CMC Spacer?
The Artelon CMC Spacer is a device developed by Artimplant AB and marketed by Small Bone Innovations Incorporated. The Artelon CMC Spacer was approved for sale in the United States in 2007, and is used to treat individuals who are suffering from early to mid stage osteoarthritis of the carpometacarpal joint of the thumb. Osteoarthritis in the thumb joint is caused by a loss of cartilage and a breakdown of the joint.
Inserted during an outpatient surgical procedure, the Artelon CMC Spacer is supposed to provide cushioning for the thumb joint where the cartilage was supposed to. It is inserted near the base of the thumb, in the first carpometacarpal joint near the wrist joint. The device seeks to serve as an interpositional spacer between the trapezium bone and first metacarpal bone.
In the three years it has been available on the United States market, the Artelon CMC Spacer has been linked to a number of adverse effects associated with its use. The Food and Drug Administration (FDA) have received reports involving bad inflammatory responses and swelling with bone loss. When these side effects occur, removal of the failed implant is very often necessary.
In other reports, the FDA has received multiple complaints of the Artelon CMC Spacer breaking apart inside the patient’s hand; this will almost certainly require additional procedures.
These additional procedures also carry risks of their own. Tendons may need to be removed from other areas of the body, such as the arm, to fully repair the thumb joint. The thumb can also become visibly misshapen following the insertion of the Artelon CMC Spacer.
Artelon CMC Spacer Side Effects
Potential Side Effects with the Artelon CMC Spacer include;
- Failure of the Device leading to painful and intrusive future procedures to remove the device
- Foreign Body Tissue Reaction
- Implant Rejection (seen through redness, persistent pain, inflammation, reduced mobility, bone loss/deterioration)
Artelon CMC Spacer Litigation
At Sheff Law, we are the Massachusetts law firm with the resources, experience, and national reputation to investigate injuries resulting from exposure to the Aretlon CMC Spacer. Patients across Massachusetts and America are starting to realize some of the potential harmful consequences of using the Aretlon CMC Spacer in connection with early to mid stage osteoarthritis. If you or a loved one has been injured as a result of the Aretlon CMC Spacer, contact an attorney at Sheff Law today by filling out a FREE consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog