The Cartiva toe implant is a synthetic cartilage device used to treat arthritis in the big toe. New evidence suggests that these implants are defectively designed and prone to failures that can result in pain, further surgery, and other injuries. Cartiva toe implant lawsuits are now being filed by individuals who experienced a premature failure of their implant.
Cartiva Toe Implant
The Cartiva toe implant is a molded synthetic cartilage implant device made from a unique material called polyvinyl hydrogel. The Cartiva implant is used to treat big toe arthritis, a condition that impacts over 2 million people in the U.S. Arthritis in the big toe gradually degrades the cartilage in the toe joint. This eventually causes the bones to grind against each other, which is extremely painful.
Until recently, the only real treatment option to alleviate the pain of advanced arthritis in the big toe was fusion surgery (arthrodesis).
So the Cartiva toe implant is a medical device that was developed as an alternative treatment for osteoarthritis of the big toe joint to deal with the injury that causes significant pain and mobility issues for patients.
This changed several years ago with the development of the Cartiva implant. The Cartiva implant is tiny and can be inserted into the metatarsophalangeal joint in the toe.
The Cartiva instrumentation is used to create a cavity of the appropriate size in the metatarsal head and to insert the Cartiva toe implant into the cavity.
The defendants claim that joint resurfacing with the Cartiva implant is a simple procedure that does not involve significant removal of healthy tissue. It also results – we were told, anyway – in minimal surgical trauma and a quick recovery time.
Once implanted, the Cartiva is supposed to essentially replace the degraded cartilage in the toe and alleviate the bone-on-bone rubbing.
Big Toe Arthritis
Big toe arthritis, also known as hallux rigidus, is a type of arthritis that affects the joint at the base of the big toe. This joint, called the first metatarsophalangeal joint, allows the big toe to move up and down. This is important to walking, running, and jumping effectively and pain-free.
In people with big toe arthritis, the cartilage that covers the ends of the bones in the joint begins to wear away. This can lead to pain, stiffness, and decreased range of motion in the joint. Over time, bone spurs may also develop around the joint, further restricting movement and increasing pain. Big toe arthritis affects about 2.2 million Americans.
Big toe arthritis is most commonly caused by wear and tear on the joint – the kind of stress with all put on our big toes. Other factors contributing to the development of big toe arthritis include genetics, foot injuries, and inflammatory conditions such as gout and rheumatoid arthritis.
Problems With the Cartiva Implant
The Cartiva toe implant has a very high rate of failure because the implant tends to shrink once implanted. The implant shrinkage causes the Cartiva implant to come loose and migrate from its implant site. When this occurs, it can cause nerve damage and debilitating pain. Patients eventually are forced to undergo additional surgery to have the Cartiva implant removed and the bones fused together.
In addition, problems with the Cartiva implant have resulted in infections, implant fracture, osteolysis, bone over-production, cysts, silastic granulomas, and other complications.
The reason for the high failure rate from shrinkage and migration of the Captiva appears to be related to the material from which the implants are made. The Cartiva implant is a polyvinyl membrane gel (PVA). The PVA material is designed to be biocompatible and mimics the properties of cartilage.
Unfortunately, in some patients, the PVA material degrades rapidly after implantation. The resulting shrinkage causes the implant to loosen and migrate.
The Manufacturer Failed to Disclose the Risks of the Cartiva Implant
The Cartiva toe implant is manufactured and sold by Stryker, an international medical device and healthcare company based in Michigan. FDA approval for the Cartiva implant was obtained through the pre-market-approval process based because the implant was “substantially equivalent” to the existing fusion surgery technique. This is a shortcut that evades full FDA review before approval.
Stryker has suppressed facts from the FDA and the public that the Cartiva implants have a very high failure rate due to shrinkage and implant migration. The initial FDA approval was obtained based on a single, very limited study that significantly understated the failure rate of the implants.
Subsequent studies have shown that the Cartiva has a much higher failure rate and presents numerous complication risks. This has prompted some health insurance companies to deem the Cartiva implant “experimental” and refuse coverage for it.
The warning label for the Cartiva indicates that the implant has a 13.5% failure rate, but evidence suggests that the actual rate of failure is much higher. A total of 144 adverse events involving the Cartiva have been reported to the FDA 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 fully aware of the evidence indicating that the Cartiva implant has an extremely high failure rate, but has failed to disclose this risk to the FDA. Despite the existence of the post-market study suggesting failure rates over 60%, Stryker has not taken any action to recall the Cartiva implant.
Stryker has also not amended its warning label or product information to accurately reflect the true risk level. The post-market studies and adverse event reports suggest that the failure rate of the Cartiva is 7 times higher that the failure rate disclosed in the warning label.
Why Did the FDA Approve Cartivia?
Baumhauer et al. (2016) conducted a study, also known as the “Motion Study,” to evaluate the effectiveness of the Cartiva Synthetic Cartilage Implant for the treatment of big toe arthritis. The study included 236 patients who received either the Cartiva implant or traditional surgical treatment for their condition.
The study found that patients who received the Cartiva toe implant experienced significantly greater improvement in pain and function compared to those who underwent traditional surgical treatment. Specifically, patients who received the Cartiva implant reported a 91% reduction in pain and a 128% improvement in joint function at two years post-surgery.
The study also found that patients who received the Cartiva implant had a lower rate of complications compared to those who underwent traditional surgical treatment. Specifically, the Cartiva group had a 7.3% rate of complications, compared to a 16.3% rate of complications in the traditional surgical group.
A follow up Motion Study showed similar results. Based on the results of these studies, the Cartiva toe implant was approved by the FDA for the treatment of big toe arthritis in 2016. But the clinical experience could not have been more different from the Motion Study. A follow-up study found failure rates as high as 64%. That was an admittedly small study but it is consistent with the high failure rate doctors were seeing on the ground.
What was the deal with the Motion Studies? We have to figure that out. But we know that the lead author of the Motion Studies also saw failures due to the implant slipping into the bone. His clinic longer uses Cartiva because he an unacceptable failure rate of these toe implants.
Cartiva Implant Failure Lawsuits
Individuals who experienced a failure of their Cartiva toe implant are now bringing product liability lawsuits against the manufacturer. These Cartiva implant lawsuits allege that the implant was defectively designed due to the issues with the PVA material. They also allege that the manufacturer knew or should have known about the high failure rate and other problems with the Captiva, but failed to disclose these risks in the warning label.
A growing number of Cartiva implant lawsuits have already been filed across the country. Many more Cartiva lawsuits are expected to be filed as patients experience premature failures and complications. If a high volume of these cases get filed over the next few months, they could potentially be consolidated into a new class action MDL.
Here’s an overview of the development of the Cartiva Toe Implant:
- In the early 2000s, Cartiva, a medical device company based in Alpharetta, Georgia, began working on a synthetic cartilage implant that could be used to treat osteoarthritis of the big toe joint. The goal was to create a device that would provide the same cushioning and shock absorption as natural cartilage, while also being durable and long-lasting.
- The Cartiva Toe Implant was developed using a proprietary polymer material that is similar in structure and function to natural cartilage. The implant is a small cylindrical device that is inserted into the big toe joint to replace damaged cartilage. It is designed to preserve joint motion and function, reduce pain and swelling, and improve overall quality of life for patients.
- Clinical trials of the Cartiva Toe Implant began in the mid-2000s, and the device received FDA approval in 2016. The approval was based on the results of two randomized controlled trials, which showed that the Cartiva Toe Implant provided significant pain relief and improved joint function compared to traditional fusion surgery.
- Since its approval in 2023, the Cartiva Toe Implant has been used in thousands of procedures in the United States and other countries.
- A post-market study suggested the failure rate with Cartiva toe implant may be as high as 64%.
Last year, lawyers began to file Cartiva toe implant lawsuit.
Pending Cartiva Implant Cases
At least 5 Cartiva toe implant lawsuits have been filed in federal courts across the country over the last 6 months. The table below lists these Cartiva product liability lawsuits, each of which was filed in a different federal district court. Interestingly, 4 of the five cases were voluntarily dismissed in September, which suggests that they may have been settled out of court.
|Gesmer v. Cartiva, Inc. et al
|Northern District of California
|Thompson v. Cartiva, Inc. et al
|Eastern District of California
|Neil v. Cartiva, Inc., et al.
|Western District of North Carolina
|Peterson v. Cartiva Inc., et al.
|Eastern District of Wisconsin
|Atkinson v. Cartiva Inc., et al.
|Western District of Texas
The Complaint filed in Peterson v. Cartiva, et al. (2:22-cv-685) in the U.S. District Court for the Eastern District of Wisconsin is typical of those filed in all of the other cases. It contains a long section detailing the development history of the Cartiva toe implant and the FDA short-track approval process.
Next, the Complaint contains a short section with detailed factual allegations regarding the plaintiff’s experience with the Cartiva implant. According to the Complaint, Peterson had the Cartiva implant surgically inserted in January 2018. The Complaint does not allege a specific failure of Peterson’s implant but claims that it was defective and failed to alleviate Peterson’s pain resulting in surgical removal and medical expenses.
Sample Cartiva Lawsuit
An example of a Cartiva implant case that may have recently settled is Atkinson v. Cartiva, Inc.- 1:22-cv-01037 (W.D. Texas). The plaintiff in that case had the Cartiva implant installed in her toe in November 2018. She subsequently experienced continuing pain and limited range of motion and just 2 years later she was told that the device was defective and it was surgically removed. Atkinson filed her lawsuit against Cartiva in the Western District of Texas in October 2022.
Last month, a notice of voluntary dismissal was filed in the case. The voluntary dismissal strongly suggests that there was a confidential settlement agreement reached in the case.
Contact Our Cartiva Implant Lawyers
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 reach out for a case evaluation online.