Cartiva Implant Lawsuit: A Comprehensive Guide (2024)

What is the Cartiva Implant Lawsuit?

A Cartiva implant is a synthetic cartilage device that is biomechanically engineered to mimic the function of natural cartilage. It is commonly used to treat osteoarthritis in the big toe, a condition known as hallux rigidus, where the cartilage wears out and leads to joint pain and stiffness.

An estimated 40% of the U.S. population have some kind of foot problems, according to a 2017 study published in the National Library of Medicine. Hallux rigidus affects an estimated 2.5% of Americans over the age of 50.

Unlike traditional treatments that often involve fusing bones to alleviate pain, the Cartiva implant allows for more movement and quicker recovery times. The implant is made of a biocompatible, durable material that provides a low-friction surface, aiming to reduce pain while maintaining joint mobility. It is small and round, similar to the size of a jellybean, and is inserted into the joint space after damaged cartilage has been removed.

History of The Cartiva Implant

The Cartiva implant, manufactured and sold by Stryker, was developed as an alternative to more invasive procedures that restrict movement. Over the years, it has become a preferred treatment option for its design focusing on preserving joint motion. The implant received approval from the U.S. Food and Drug Administration (FDA) in 2016 after clinical trials demonstrated its ability to reduce pain and improve physical function for patients with osteoarthritis in the toe.

How Effective and Safe Is the Cartiva Implant?

The summary of safety and effectiveness data issued by the FDA in 2016 revealed that nearly 89% of Cartiva subjects experienced a significant decrease in pain and 87.7% of the subjects had a clinically significant increase in function.

However, Stryker obtained FDA approval for the Cartiva toe implant through the pre-market approval process, which is considered a shortcut to approval that evades a comprehensive review by the federal agency.

The effectiveness and safety of the Cartiva implant have come under increased scrutiny as a large number of users reported high failure rates caused by implant shrinkage and migration. Plaintiffs in a typical Cartiva implant failure lawsuit alleges that Stryker suppressed facts from both the public and the FDA about problems with the implant to minimize the actual failure rate.

Why Do Cartiva Implants Fail?

Like any medical device, Cartiva implants come with the risk of complications or failure. Some reasons for implant failure include:

• The development of scar tissue around the implant, which can restrict movement;

• Shrinkage of the implant due to the lack of hydration;

• Infection around the implant site;

• Implant dislocation or loosening, potentially caused by high-impact activities or improper placement during surgery;

• Bone weakening around the implant; and

• Continuous pain post-surgery, which could indicate that the body is not responding to the implant as expected.

When these issues occur – specifically implant shrinkage and loosening – patients are likely to suffer debilitating pain and serious nerve damage. This may require a patient to undergo an additional surgery to remove or replace the implant. In some patients, Cartiva implant failure may also result in complications such as infections, osteolysis, cysts, bone over-production, and other problems.

If a patient experiences symptoms of Cartiva implant failure, they should consult their orthopedic surgeon to discuss treatment options, which may include removal or replacement of the implant. If the failure was caused by Stryker’s failure to disclose the known risks of the implant or other forms of negligence on the part of the manufacturer, you could be entitled to financial compensation through a Cartiva toe implant lawsuit.

Can You File a Cartiva Lawsuit?

Patients who have experienced significant complications or failures with their Cartiva implants may consider legal action against Stryker. Grounds for a Cartiva implant lawsuit could include:

• Faulty implant design

• Inadequate warnings or instructions provided with the implant

• Manufacturing defects

If you believe your complications are due to one of these issues, you should seek legal advice from a lawyer experienced in drug and medical device litigation. A lawyer can offer guidance on your rights and potential next steps, including the possibility of receiving compensation for medical costs, pain, and suffering resulting from a failed implant.

Cartiva Implant Failure Symptoms (2024)

The Cartiva Implant Lawsuit has brought to light a multitude of serious complications that patients have experienced following the implantation of the Cartiva device. Despite the initial promise of the implant as a revolutionary solution for big toe arthritis, the reality has proven far less rosy for many patients.

One of the most common complications reported is severe and persistent toe pain, which not only limits the mobility of patients but also significantly impacts their quality of life. This pain is often a result of the implant loosening within the joint or fracturing, both of which can cause the joint to fail.

Subsidence, a condition in which the implant sinks into the bone, has also been frequently reported. This can result in further pain and necessitate additional surgeries to correct the issue.

More worryingly, some patients have reported nerve damage and debilitating pain due to the Cartiva implant shrinking once implanted. This shrinkage can cause the implant to migrate from its original position, leading to serious complications.

Toe Pain

One of the most common complications reported is severe and persistent toe pain, which not only limits the mobility of patients but also significantly impacts their quality of life. This pain is often a result of the implant loosening within the joint or fracturing, both of which can cause the joint to fail.

Subsidence

Subsidence, a condition in which the implant sinks into the bone, has also been frequently reported. This can result in further pain and necessitate additional surgeries to correct the issue.

Nerve Damage

More worryingly, some patients have reported nerve damage and debilitating pain due to the Cartiva implant shrinking once implanted. This shrinkage can cause the implant to migrate from its original position, leading to serious complications.

Additional complications reported in the lawsuit include infections, implant fracture, osteolysis (the destruction or disappearance of bone tissue), bone over-production, cysts, and silastic granulomas. These complications often necessitate further surgeries, increasing the patient's suffering, medical costs, and recovery time.

At ConsumerShield, we believe that patients deserve justice and compensation for these complications. We meticulously connect individuals with our network of skilled lawyers, handpicked for their expertise in class action lawsuit claims like the Cartiva Implant Lawsuit. Our commitment goes beyond just making connections. We provide a partnership in your journey towards justice, offering guidance and support every step of the way.

Several studies that have raised concerns about the Cartiva implant's efficacy and safety:

• November 2022 Study: Preliminary findings of an ongoing study published in a medical journal found that patients who received the Cartiva toe implant reported more post-operative pain. The study reviewed 50 patients who underwent Cartiva hemiarthroplasty, arthrodesis (fusion of the joint), or interpositional arthroplasty. It found that Cartiva patients reported a worse overall combination of postoperative pain, function, and alignment compared to patients who received the alternative treatments.

• October 2020 Study: A study published by the American Orthopedic Foot and Ankle Society indicated a high failure risk for patients receiving Cartiva implants for the treatment of hallux rigidus. Within two years of receiving the implant, there was a 79% implant failure risk. Furthermore, 64% of patients who received a Cartiva implant experienced device failure within four weeks of the surgery. The most commonly reported reason for Cartiva failure was subsidence, where the implant loosened and sank into the toe bone, resulting in severe toe pain and revision surgery in some cases.

• October 2019 Study: Researchers from Cedar Sinai Hospital found that 30% of Cartiva Synthetic Cartilage Implant (SCI) recipients were either dissatisfied or very dissatisfied with the outcomes of the procedure. The study found 50% required a corticosteroid injection after receiving the implant. The researchers concluded that the Cartiva implant only yielded modest patient satisfaction, with a large proportion requiring further treatment and workup postoperatively.

If you or a loved one has experienced any of these complications following the implantation of the Cartiva device, reach out to ConsumerShield. We're here to help you understand your rights and to support you in your claim for compensation. You do not have to navigate this complex legal landscape alone. With ConsumerShield, you have a partner committed to helping you seek the justice you deserve.