Is There a Cartiva Toe Implant Lawsuit?

Yes. Lawsuits are being pursued against the manufacturers of the Cartiva synthetic cartilage implant for individuals throughout the United States who suffered complications that resulted in the need for a toe fusion, revision or replacement surgery.  Cartiva lawsuit payouts may be available as a result of design defects that resulted in a high toe implant failure rates.

In 2016, the U.S. Food and Drug Administration approved the Cartiva big toe joint implant, which was aggressively marketed by the manufacturer as a breakthrough alternative to big toe fusion surgery, for treatment of arthritis in the big toe.  

The Cartiva toe implant surgery was intended to increase mobility of the foot, and improve overall quality of life. However, patients began experiencing much higher rates of pain and complications from Cartiva implant failures than were previously disclosed by the manufacturer during clinical trials.

While Cartiva was approved largely on the perceived benefits and clinical trials that showed only a 13.5% toe implant failure rate, a study was published in 2020 finding the actual rate of Cartiva implants failing in patients within the first several months were as high as 64%.

As a result of the manufacturers failure to adequately research the safety and effectiveness of Cartiva, many patients have been left with severe pain from the big toe implant failing, requiring additional revision or removal surgeries, often causing the big toe to be significantly shortened and stiff due to the amount of bone removed.

What is the Cartiva toe implant and what are its uses?

The Cartiva toe implant is a small, gel-like device that is made of a biomaterial that mimics natural cartilage in the big toe joint.

The Cartiva synthetic cartilage joint is used to replace damaged or deteriorated cartilage in the first metatarsophalangeal joint, to provide cushioning and prevent the joint bones from rubbing together.

Cartiva implants are routinely offered to individuals who suffer from conditions known as Hallux Limitus or Hallux Rigidus, which are forms of big toe arthritis that cause debilitating pain and stiffness in the joint that can worsen over time and limit the mobility of the big toe.

Hallux Limitus is a form of degenerative arthritis that causes a limited range in motion of the big toe.

Symptoms of Hallux Limitus can include difficulty walking normally, pain on weight bearing surfaces, discomforts while turning or sudden movements and often there may be bony growths in the area. However, hallux limitus may progress to hallux rigidus.

Hallux Rigidus is a severe type of degenerative arthritis in which hardly any or no cartilage of the joint remains, and causes a much more painful restricted range in motion of the toe.

Symptoms of Hallux Rigidus can range from difficulty bending the great toe joint when walking to intense pain and stiffness in the joint itself. Stiffness tends to worsen over time, with advanced cases becoming unable to move their toe at all.

Cartiva Implant Failure

Cartiva was first given premarket approval by the FDA in 2016, based on the results of the Motion clinical study, which the manufacturer used to establish a “substantial equivalence” to arthrodesis, and claimed there was only a 13.5% Cartiva implant failure rate.

However, the results of this Cartiva study have never been duplicated and the failure rate is much higher than the Motion study predicted, according to follow-up studies and case reports. In fact, there is evidence that revisions after a Cartiva failure may cause more severe long term foot side effects than originally receiving arthrodesis.

Cartiva Device Associated With 64% Failure Rate after 4 Weeks: Study

According to a study published by the American Orthopedic Foot and Ankle Society in November 2020, researchers found as many as 64% of patients who received Cartiva for Hallux Rigidus experienced device failure within four weeks of the surgery. The number of Cartiva implant failures increased to 79% at 19 months post-surgery.

Specifically, the study found the most commonly reported reason for Cartiva failure was subsidence, which is the sinking of the implant into the bone. This condition has been associated with severe toe pain that often requires revision surgeries.

Additional side effects of Cartiva found in the study included: 

• 40% of patients experienced erosion of the toe bone that is closest to the metatarsals, 
• 57% showed radiologic lucency around the implant, 
• 43% of patients reported no pain or mobility improvement 19 months after surgery.

Half of Cartiva Recipients Experience Stiffness and Limited Mobility

In a study published in the medical journal Cureus on November 19, 2023, researchers from the U.K. found that 45.5% of Cartiva recipients experienced complications related to the medical procedure, surgical process, and the implant itself. Additionally, a 55% reported persistent pain at their final follow-up appointment while 50% experienced stiffness or limited mobility, and 10% reported persistent swelling.

The study also pointed out that ongoing pain was a frequent issue, leading to the need for additional interventions such as orthotics, debridement, or repositioning of the implant. Researchers found that nearly 20% of individuals required subsequent surgeries to correct or remove the implant.

Cartiva Implant Failures Worsen Patient Outcomes

While Cartiva implants have been marketed as a safe and beneficial alternative to big toe fusion surgery, medical experts have challenged these claims, suggesting that when a Cartiva implant fails, it may actually cause a patient more harm than initially receiving a toe fusion.

The Mayo Clinic reported salvage surgery to repair a failed Cartiva implant creates significant reconstructive problems because joint replacement surgery requires a large amount of bone to be removed.

As a result, reports suggest many are left with a significantly shortened great toe that can lead to a condition known as transfer metatarsalgia. This condition creates excessive offloading and typically causes the big toe to stick up, not touching the floor.

Why Does The Cartiva Implant Fail?

Medical experts from the University Foot and Ankle Institute have offered several theories on why the Cartiva synthetic cartilage implant can fail, all of which revolve around a suggested faulty and defective design that makes them prone to loosening and allowing the gel-like device to slip into the bone, known as subsidence.

Improperly Textured Design

Medical experts theorized that Cartiva implants were improperly designed with a smooth surface on the surrounding sides, rather than containing some form of irregularity, which may allow them to move or sink out of place.

The University Foot & Ankle Institute has suggested this exceptionally smooth design creates a functional flaw that makes the implant prone to loosening, especially when routine force is applied to the area.

Cartiva Implant Shrinking

The Institute has also theorized that Cartiva implants may shrink after they are implanted due to the lack of hydration. Dr. Baravarian from the Institute stated in an article published in Podiatry Today, that the Cartiva implant is largely water-based and is soaked in a water medium prior to being implanted.

Experts theorize that after Cartiva is implanted it may lack hydration from the surrounding joint, allowing it to shrink and slip into the bone.

Bone Weakening Around The Implant

The University Foot & Ankle Institute has also suggested the Cartiva implant may fail due to the bone surrounding the implant being too weak, and failing to provide adequate support. The smooth surfaces of the implant combined with a lack of support to hold the implant in place could allow loosening and implant slipping.

Cartiva Implant Failure Symptoms

Some of the most common symptoms of Cartiva failure include;

Cartiva Implant Failure Lawsuit Settlements

As a result of the manufacturer’s apparent faulty design of the Cartiva SCI decision and desire to profit before the health and safety of patients, Cartiva lawsuit settlements may be available.

The product liability lawyers at Saiontz & Kirk, P.A. are actively investigating Cartiva lawsuits for individuals who have suffered complications resulting in the need for revision or replacement surgery.

How Much Is A Cartiva Settlement Worth?

The value of potential Cartiva settlements could vary depending on several factors. Individuals who suffered injuries resulting in permanent disability may be entitled to higher settlement payouts than those with successful revision surgery.

In determining the amount of any individual Cartiva lawsuit payout, the following are some of the common factors that will be taken into consideration when negotiating or evaluating any offers:

• How many Cartiva implants an individual received;
• The specific injuries caused by Cartiva;
• The amount of any past or future medical expenses;
• The amount of any lost wages or loss of earning capacity;
• The level of impact Cartiva has caused on the individual’s overall physical and mental health or well-being;
• The past and future amount of pain and mental anguish suffered by the individual;

Are there any costs to hire a Cartiva toe implant lawyer?

There are absolutely no out-of-pocket costs to hire our Cartiva lawyers for your toe implant failure case. Potential claims are evaluated for individuals throughout the United States, and all cases are handled on a contingency fee basis. Through the use of contingency attorney fees, individuals have access to the experience and resources of our national law firm for their Cartiva lawsuit — regardless of their individual financial resources.

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