Cartiva Toe Implants Pose High Risk of Failure; Lawsuits Increasing

The Cartiva toe implant has become a commonly used device aimed at relieving symptoms of arthritis in the big toe. It has, however, been known to fail at an abnormally high rate, causing pain, loss of motion, and even additional surgery. If you or someone you know has experienced adverse health effects from receiving the Cartiva toe implant, you may want to keep reading.

About the Cartiva Implant

The Cartiva toe implant was manufactured to treat symptoms of big toe arthritis. This type of arthritis occurs when cartilage is damaged, or worn down, in the big toe joint. The degraded cartilage causes the bones to rub together, which can lead to pain, stiffness, and swelling. The Cartiva implant is a synthetic replacement for the degraded cartilage. Its primary purpose is to reduce bone-on-bone friction in the metatarsophalangeal joint in the big toe. It is specifically molded from Polyvinyl Hydrogel (PVA Hydrogel), and is roughly the size of a popcorn kernel. Prior to this implant, the only viable treatment option for big toe arthritis was a difficult fusion surgery that left the patient with limited mobility. This product became the first openly accessible alternative to fusion surgery.

Problems with the Cartiva Implant

The primary issue with the Cartiva toe implant is that it has a high rate of failure. The material, PVA Hydrogel, has a tendency to compress after being implanted. The shrinkage of the implant then leads to migration, and often results in the implant shifting out of position. When the implant moves out of place, it can cause nerve damage and result in extreme pain. Additional surgery must then be conducted to alleviate the pain and correct the PVA Hydrogel implant. In addition to pain, and additional surgery, there are also other negative health impacts of a failed Cartiva implant including infections, osteolysis (bone degeneration), cysts, and silastic granulomas (a skin tissue condition).

Basis of Cartiva Litigation

Cartiva, Inc. was the company who originally developed the Cartiva toe implant. Stryker, a global healthcare and medical device company, acquired Cartiva, Inc. in 2019 and is now the manufacturer of the Cartiva toe implant. The product was approved through a pre-market approval system. However, reports indicate that the company may not have disclosed to the FDA or the public data indicating a higher failure rate. The product label claims the failure rate is 13.5%, but this number is significantly lower than the actual reported rate of failure, with some studies indicating failure rates in excess of 50%. Stryker has not (yet) acknowledged concerning issues with the product. The company has made no effort to revise its warning label, nor does the company have plans for product recall. The failure rate and complicated health risks associated with the Cartiva implant are so significant that some health insurance agencies have refused to cover it, as they deem the implant an ‘experimental’ medicine. Individuals who have had adverse health effects after receiving the Cartiva implant have begun to file lawsuits across the country. The litigation is based on the allegation that Stryker knew about the potentially high failure rates but failed to properly warn the consumer. The volume of these cases is increasing.

If you or a loved one received the Cartiva toe implant and were met with detrimental health effects, first talk to your doctor. If you are interested in pursuing legal action, do not hesitate to reach out to Attorney Clay Hodges at 919.334.6277 for a consultation.

Note: This blog post was written based on research utilizing the FDA website and online news sources.