Products Liability
The Cartiva is an artificial cartilage toe implant that is designed to help treat and relieve the symptoms of arthritis in the large toe. It has recently been determined that the Cartiva implants may be defective in design and have a very high rate of failure. Failure of the Cartiva implant causes significant pain, loss of motion, and eventually requires additional surgery.
Our firm is currently seeking Cartiva implant lawsuits across the U.S. from individuals who suffered a premature failure of a Cartiva toe implant. Call us today at 800-553-8082 for a free consultation.
Big Toe Arthritis
Big toe arthritis (hallux limitus) is a medical condition that causes stiffness and pain in the joint located at the base of the big toe. The big toe joint is commonly referred to as the first metatarsophalangeal joint. It plays an important role – a much bigger role than people think – in maintaining balance and facilitating walking. Over time as we age, it takes a pounding from stress and pressure.
The primary cause of big toe arthritis is typically attributed to wear and tear on the joint, which can lead to the development of bone spurs and cartilage loss. As the joint becomes damaged, it can become inflamed, leading to symptoms such as pain, swelling, and stiffness. With time, the range of motion of the big toe can become limited, which can make it challenging to engage in physical activities like walking and running.
In addition to wear and tear, other potential causes of big toe arthritis can include trauma, infection, or inflammatory conditions like gout or rheumatoid arthritis. It is crucial to seek medical attention from a healthcare provider if you experience pain or stiffness in your big toe joint, as early diagnosis and treatment can prevent further damage.
The traditional treatment options for big toe arthritis may include non-surgical approaches such as physical therapy, anti-inflammatory medications, or custom orthotics to support the foot. In some situations, surgical interventions like joint fusion or joint replacement may be necessary to alleviate pain and restore function. Cartiva came along with what was purported to be a revolutionary break through to treat big toe arthritis.
About the Cartiva Implant
The Cartiva is a new and unique type of implant device that is implanted in the big toe to treat the painful symptoms of big toe arthritis. Big toe arthritis is primarily caused by degrading of the cartilage in the big toe joint.
The Cartiva implant was specially designed to act as a synthetic replacement for the degraded cartilage in the big toe. It is a specially molded implant about the size of a pea. The Cartiva is made from a special material called polyvinyl hydrogel (PVA hydrogel). PVA hydrogels have been around for a long time and they are widely used in the medical device field because of their unique properties.
Prior to the Cartiva, the only real treatment option for big toe arthritis was fusion surgery (arthrodesis), in which the bones in the toe joint are surgically fused together to prevent friction. This is a difficult surgery and it leaves the individual with limited mobility in the toe.
The Cartiva was developed as the first alternative treatment for big toe arthritis. The Cartiva implant is very small (about the size of a pea) and designed to be inserted into the metatarsophalangeal joint in the toe. To insert the Cartiva, special instruments are used to open a cavity in the metatarsal joint into which the implant is implanted.
Once properly implanted into the joint, the Cartiva implant is supposed to serve as a synthetic replacement for the degraded cartilage and alleviate the bone on bone friction.
Cartiva Implant Problems
Since it was first released on the market, the Cartiva implant has proven to be very problematic and it is now clear that the implant has an abnormally high rate of failure. The primary reason for the high failure rate of the Cartiva is that the PVA hydrogel material that the implant is made out of has a tendency to shrink and compress after being implanted.
Shrinkage of the Cartiva implant after insertion causes the implant to become mobile and move out of its original implant position. Migration of the Cartiva implant can impact nerves and cause extreme pain. When migration of the implant occurs that patient must undergo corrective surgery to have the implant removed to alleviate the pain.
These issues with the Cartiva implant have also resulted in infections, implant fracture, osteolysis, bone over-production, cysts, silastic granulomas, and other complications. The reason for the post-implantation shrinkage and migration of the Captiva appears to be related to the material from which the implants are made.
The Cartiva is made from a polyvinyl membrane gel that is designed to be biocompatible and mimic the properties of human cartilage. In certain patients, however, the polyvinyl material rapidly erodes after implantation and loses its structural integrity. The resulting shrinkage is what causes the implant to loosen and migrate.
The Risks of the Cartiva Implant Were Not Fully Disclosed
The manufacturer of the Cartiva toe implant is Stryker, a global medical device and healthcare product company headquartered in Michigan.
The Cartiva implant was approved by the FDA via the pre-market-approval process on the grounds that the Cartiva implant was “substantially equivalent” to the existing fusion surgery technique. This pre-market-approval is a shortcut process that avoids full FDA review before approval.
Stryker has not fully disclosed to the FDA or the public the facts regarding the high failure rate and problems with the Cartiva implant. The initial FDA approval for Cartiva was obtained based on a single, very limited study. That study significantly understated the failure rate of the implants.
Subsequent studies have demonstrated that the Cartiva implants have a significantly higher failure rate and present numerous complication risks. The failure rate and problems with the Cartiva implant are so significant that many health insurance companies have classified the implant as “experimental” and refused to cover it.
The product label for the Cartiva implant claims it has a failure rate of just 13.5%. This is not accurate and represents a drastic understatement. Evidence suggests that the actual rate of failure for the Cartiva implant could be 6 times higher.
The FDA has received a total of 144 adverse events involving the Cartiva since it was first approved. Almost all of these events involved the migration of the implant due to shrinkage. A post-market study found that patients with the Cartiva implant reported failure rates as high as 64%.
Stryker is well aware of the evidence indicating that the failure rate for the Cartiva implant is much higher than disclosed. Despite this evidence, however, Stryker has refused to acknowledge the problem, revise its warning label, or disclose the increased risk level to the FDA. Stryker has also not given any indication that it might initiate a recall of the Cartiva implant.
Cartiva Implant Lawsuits
Individuals who had the Cartiva implant inserted in their toe and subsequently suffered a premature failure of that implant have been bringing product liability lawsuits across the country. These Cartiva lawsuits allege that the implant was defectively designed and that Stryker knew about the increased failure rates but negligently failed to warn about them.
The number of Cartiva implant failure lawsuits filed across the country has slowing been growing over the last year. The volume of Cartiva product liability cases is expect to increase significantly as more of these implants fail prematurely. At this stage, there are not enough Cartiva cases pending to warrant consolidation into a new class action MDL. That could certainly change if more cases start to get filed.
Contact Us About a Cartiva Implant Lawsuit
Our firm is currently seeking Caritva implant cases from anyone who had the Cartiva toe implant surgically installed and subsequently experienced a failure or other complications with the implant. Contact us at 800-553-8082 for a free consultation or contact us online.