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Lawsuits concerning bone screws began in the 1990s, with AcroMed’s spinal pedicle implants. Although the FDA approved them in 1993, use specifically for spinal fusion remained an “off-label” medical treatment. After lawsuits during the period, the FDA now classifies these bone screws as an acceptable spinal fusion treatment.
In more recent years, CALAXO Osteoconductive Interference Screws, or simply CALAXO screws, have come under fire. Approved by the FDA in 2006, this bio-absorbable polymer and calcium carbonate medical device gave a supposed improvement to the standard metal forms used before; researchers claimed it promoted bone growth and the body absorbed it quicker, resulting in quicker recovery time.
However, by August 2007, the FDA recalled it, citing patients’ complaints of swelling, pain, pockets of fluids, and fragmentation. The recall included all CALAXO numbers and item codes.
Smith & Nephew’s endoscopy division manufactured CALAXO screws for reconstructive anterior cruciate ligament (ACL) surgery, a procedure for the bone extending from the shin through the central knee joint up to the thigh. The procedure restores normal movement, and in the past, surgeons harvested a ligament from another part of the body and secured it with metal screws.
With CALAXO, researchers believed the product assisted with maintaining the bone’s structural integrity. As a result, surgeons recommended them for thousands of patients.
After reports of screws breaking and leaving fragments in adjacent tissue, doctors requested a recall. Data showed the screws dissolved too quickly in the body, making the new joint fall apart. More surgical procedures became necessary: local debridement to remove the affected tissue or bone, or a second or third knee surgery.
Patients given CALAXO screws saw athletic careers ending, higher insurance rates, and increased psychological strain.
Filing a Bone Screw Lawsuit
For a patient, it’s a life-altering experience to receive a defective medical product, from the costs of additional surgery to physical and emotional distress. Since the FDA’s recall, recipients have filed lawsuits to cover the costs of additional care, loss of income and livelihood, and pain and suffering.