Cartiva Toe Implant

Foot X-Ray

Neumann Law Group is accepting claims against Cartiva, Inc, Stryker, and Wright Medical Group related to their defective Cartiva toe implant, designed to treat big toe arthritis (formally known as hallux rigidus). Cartiva toe implants are designed to act as artificial cartilage and prevent bone rubbing. Typically ation can also contribute. The goal of a Cartiva toe implant is to relieve pain, swelling, and stiffness due to stress and pressure placed on that toe over time. Prior to Cartiva, the only options for treatment were joint fusion, therapy, pain medication, and splints. The Cartiva toe implants was believed to be a groundbreaking solution to big toe arthritis and would allow relief without loss of movement of the toe.

Most people do not take into consideration the importance of the big toe. It is vital for creating leverage for balance, walking, and standing. Over time, when arthritis develops, one can experience serious pain and limited ability to perform daily activities. Almost all of our foot control comes from the big toe. 

Where Did the Cartiva Toe Implant Go Wrong?

Cartiva Implant

The Cartiva toe implant is made with a substance called polyvinyl alcohol (PVA) which is designed to mimic the bodies natural cartilage. When someone receives a Cartiva toe implant, the procedure is minimally invasive, and a very small implant is placed in the joint. The chemicals used to produce the Cartiva toe implant are supposed to be compatible with human biology; however, it has been found that gel rapidly erodes or shrinks and causes the loss of reliable function. The implant will move from its original position resulting in serious complications.

As a result of these Cartiva toe implant failures, many people require painful revision surgeries which can prevent all movement of the big toe.

Manufacturers Had Prior Knowledge of Defects in Cartiva Toe Implant

The Cartiva toe implant was ‘fast tracked’ for approval through the Food and Drug Administration (FDA). This approval was based solely on the alleged benefit of the implant versus fusion surgery. Further, this approval was given after the review of one very inadequate scientific study. The manufacturers of the Cartiva toe implants have the results of studies that prove a high failure rate; however, its warning label states that there is only a 13.5% chance of failure. The manufacturers of the Cartiva toe implant have—and continue to— intentionally hide information from the FDA and patients that their failure rate is much higher.

Later studies confirmed that the risk of failure of a Cartiva toe implant is indeed much higher than Cartiva reported. One study found that the failure rates were as high as 64%! Some health insurance companies, including Medicare, have stopped coverage for Cartiva toe implants due to the severity of the danger of this product, classifying it as experimental.

As a result, legal claims are being evaluated regarding Cartiva toe implants claiming that this product with sold with knowledge of defects in design, manufacturing, and marketing defects. The legal claims also allege that Cartiva and its manufacturers have refused to admit the dangers of the Cartiva toe implant and continue to market it to patients and their doctors as safe and effective. There is still no indication of a possible recall.

As of July 2023, there were around 240 reports of failures from the Cartiva toe implant. A comprehensive study of results from 2016-2023 found that the majority of those who reported issues with their Cartiva toe implant were to have revision surgery. Evaluation of 102 revisions showed that 70% of those revisions required a total fusion of the toe joint.

Cartiva Device Study Chart 1
Cartiva Device Study Chart 1

The FDA should have performed a thorough evaluation of the Cartiva toe implants prior to approval. There is high pressure on patients to utilize these devices due to heavy marketing and claims of success. Patients and their physicians should be provided with accurate and non-deceptive information regarding their potential health outcomes. These manufacturers are driven by their profits, not by patient care.

Who May be Eligible to Bring a Claim Against Cartiva?

You may be eligible to file a Cartiva toe implant lawsuit if you or a loved one have:

  • Received a Cartiva toe implant for arthritis;
  • Had a premature failure of the implant
  • Have complications from the implant, including severe pain and surgical revision.

Do You Feel That You or a Loved One Have Been Injured by a Cartiva Toe Implant?

Schedule a Free Consultation with Neumann Law Group’s Experienced Defective Medical Device Attorneys in Traverse City, Grand Rapids or Detroit

When one seeks relief from a painful condition, they typically take the word of a device manufacturer and their doctors regarding its safety. If the device manufacturer conceals information from governmental agencies and physicians, this trust can be broken, and people can be seriously injured. If your family finds itself in this challenging situation, Neumann Law Group’s attorneys maintain a wide range of skill and expertise in order to bring claims against product manufacturers. To receive the most compensation for your injuries, medical expenses, lost wages, pain and suffering, and other damages you should be represented by educated and involved attorneys.  

Neumann Law Group is dedicated to serving our clients with a range of legal services including Mass Torts and Personal Injury throughout Michigan, as well as in New York, California, and Massachusetts. Contact us at 800-525-NEUMANN or via our online form for a free consultation with a product liability attorney.

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