Important Safety Information
CARTICEL should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin.
It should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb.
Pre-existing conditions, including meniscal tears, joint instability, or malalignment should be assessed and treated prior to or concurrent with CARTICEL implantation.
CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL.
Use of CARTICEL in children, patients over age 65, or in joints other than the knee has not yet been assessed.
The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. The most common serious adverse events (≥5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.