The Cartiva is a synthetic cartilage toe implant specifically designed to ease the pain and discomfort from arthritis that affects the big toe. However, it was recently discovered that the Cartiva implant could be defective in design and have a high failure rate. Failure to repair the Cartiva implant can cause severe discomfort and loss of motion and ultimately require further surgery.
We are currently seeking Cartiva implant lawsuits throughout the U.S. from individuals who were unable to repair the Cartiva fore-implant prematurely. Fill the form on this page or Call +1-530-201-4340 to receive a free consultation.
Cartiva is a revolutionary and distinctive implant device implanted into the big toe to treat the symptoms of pain accompanying extensive toe arthritis. Significant toe arthritis is caused by the degradation of cartilage within that joint.
The Cartiva implant was specifically created to replace degraded cartilage in the large toe. It is a custom-moulded implant about the size of a pea. The Cartiva is made of an exclusive material known as polyvinyl hydrogel ( PVA hydrogel). PVA hydrogels have existed for a long time and are extensively used in medical devices due to their unique characteristics.
Before the Cartiva, the only viable alternative for treating large toe joint arthritis was fusion surgery (arthrodesis), in which the bones that make up the joint of the toe are surgically bonded to avoid friction. This is a complex procedure that leaves the person with limited mobility of the toe.
The Cartiva was created as the first treatment option for toe arthritis that is big. The Cartiva implant is tiny (about the same size as one pea) and is designed to be placed into the metatarsophalangeal joints in the toe. Special instruments are utilized to create a hole in the metatarsal joint where the implant is placed to insert the Cartiva implant.
Once it is properly placed into the joint, The Cartiva implant is designed to replace degraded cartilage and ease bone-on-bone friction.
Since it was first introduced to the public in 2000, the Cartiva implant has not proved to be a major issue, and it is now evident that it has an abnormally high failure rate. The main reason for the high failure rate is that the PVA hydrogel that the implant is composed of is prone to shrinking and expanding after it is implanted.
The shrinkage of the Cartiva implant after its insertion causes it to be mobile and move out of its initial position. Moving the Cartiva implant could affect nerves and trigger extreme pain. When implant migration occurs, the patient will need to undergo corrective surgery to have the implant removed to ease the pain.
The issues that have been reported related to the Cartiva implant can also lead to implants with fractures, infections, osteolysis, bone production overproduction, cysts, silastic granulomas, and other complications. The cause of post-implantation shrinkage and the migration of the Captiva is believed to be the materials in which the implants are constructed.
The Cartiva is the polyvinyl membrane gel made to be biocompatible and resemble the characteristics of human cartilage. For some patients, however, the polyvinyl gel rapidly degrades after the implant and loses its structural strength—the resultant shrinkage results in the implant’s ability to become loose and move.
The company that manufactures Cartiva toe implants Cartiva, the toe-implant, is Stryker, the world’s most significant medical device and health product company based in Michigan.
The FDA approved Cartiva. The FDA approved the Cartiva implant through the pre-market approval process based on the belief that it is “substantially equivalent” to the current fusion surgery procedure. This pre-market approval is a shortcut procedure that bypasses a complete FDA review before approval.
Stryker has not yet fully revealed to its FDA or the general public the facts about the high rate of failure and the issues related to the Cartiva implant. The initial FDA acceptance of Cartiva was based on one extremely limited study, which significantly understated the rate of failure for the implant.
The subsequent studies have shown that Cartiva implants have a substantially greater failure rate and carry multiple complication risks. The failure rate and the issues associated with Cartiva’s implant Cartiva implants are so severe that several health insurance companies have classified the device in the category of “experimental” and refused to accept it as a medical procedure.
The label on the Cartiva implant product states that it has the lowest failure rate, which is 13.5 per cent. This isn’t true and is a vast understatement. Research suggests that the actual rate of failure of the Cartiva implant maybe six times greater.
The FDA has reported a total of 144 adverse events related to the Cartiva since the first time it was approved. Most of these incidents resulted in the displacement of the implant as a result of shrinkage. A post-market study revealed that patients using the Cartiva implant experienced failure rates of up to 64 per cent.
Stryker is informed of research suggesting that the failure risk of Cartiva is much higher than previously reported. The Cartiva implant is more than what is disclosed. However, despite this evidence, Stryker has refused to admit the issue, change the warning label on its product, or reveal the risk to the FDA. Stryker has not provided any indication of whether or not it will start a recall for Cartiva.
The signs of a failing Cartiva implant can be seen in the following:
The class action suit regarding the Cartiva implant has yet to be filed on May 8, 2023.
You could earn more money if you file an individual lawsuit instead of an action class.
Contact us now for a complimentary consultation. We will discuss whether it’s best to file a personal lawsuit or an action for a class.
The lawsuits seek the costs of those whose failures of Cartiva implants have afflicted. They claim that Stryker:
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We are currently seeking Caritva Implant cases from any person who’s had an implant, like the Cartiva toe implant, installed surgically and then experienced malfunction or other issues related to the implant. Call
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