A growing number of lawsuits have been filed nationwide by people who needed surgery when their Cartiva toe implant failed or caused serious complications.
Need a Texas Cartiva Toe Implant Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were injured or needed surgery for a Cartiva Toe Implant that failed, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is the Cartiva Implant?
The Cartiva toe implant is a medical device that was developed by Cartiva Inc. for the treatment of big toe arthritis (or “hallux rigidus”), a painful condition that destroys the natural cartilage in the joint at the base of the big toe.
The device is also called the Cartiva Synthetic Cartilage Implant (SCI) because it is made of a man-made hydrogel that mimics cartilage.
How Does It Work?
The plug-shaped Cartiva device is implanted into a hole that a surgeon drills into the toe bone. The implant is supposed to stick out of the bone about 2-3 millimeters, providing a slippery gel cushion that is designed to replace the cartilage that was destroyed by arthritis.
Cartiva Toe Implant vs. Toe Fusion Surgery
Before the Cartiva toe implant was approved by the FDA in 2016, the only alternative treatment for people with big toe arthritis was a surgery to fuse the joints in the toe together with screws and plates.
Toe fusion surgery eliminates toe pain due to arthritis, but the problem is that the toe loses all of its flexibility, which can lead to mobility problems. This is a disadvantage for younger, more active patients.
Early Hype Turned to Disappointment and Anger
When the Cartiva implant was first approved, doctors were initially very excited to have an alternative to fusion surgery. The device was simple to implant and had a quick recovery time. The manufacturer also claimed that over 80% of patients were satisfied with the results.
What is the Problem?
Unfortunately, the initial hype soon turned to disappointment and anger, as more and more patients developed serious complications when the Cartiva implant slipped inside the bone and became ineffective, or failed for other reasons that required another surgery.
Doctors May Not Be Aware of Risks
Even more alarming, the manufacturer (Stryker) refused to fully investigate the reports or notify the FDA — leaving surgeons to publish their own case reports and studies to warn other doctors.
Cartiva Toe Implant Fails in 50% of Patients
One of the earliest studies found that about 50% of Cartiva implants failed, according to the University Foot & Ankle Institute. The doctors emphatically warned patients who want to get one of these devices to “NOT GET A CARTIVA IMPLANT until further notice.”
Risk of Cartiva Side Effects May Be Even Higher
Another study published more recently in October 2020 warned that the risk of Cartiva implant failure may be even higher. There was a 4-week failure-rate of 64%, which increased dramatically to a 79% failure-rate by 19 months post-surgery.
The study was published by the journal Foot & Ankle Orthopaedics — “Early Failures of Polyvinyl Alcohol Hydrogel Implant for the Treatment of Hallux Rigidus” by Dr. Yoshiharu Shimozono of the Department of Orthopedic Surgery at NYU Langone Health.
Manufacturer Claimed Cartiva Had Only 13.5% Failure Rate
The official warning label for the Cartiva toe implant claims that the failure-rate is only 13.5%, which is what the manufacturer told the FDA based on a single, limited study based on 236 patients that was called the Motion Study. Despite growing evidence that this may have vastly under-estimated the risk of implant failures, the manufacturer has not launched another safety study to investigate.
What Is Causing Cartiva Toe Implant Failures?
Case reports suggest that the Cartiva toe implant may have design flaws that allow it to loosen, move out of position, shrink, or slip deep inside the toe bone (a complication called subsidence) where it is completely useless for preventing pain caused by big toe arthritis.
What is the Risk?
- Cartiva implant slips inside the bone (subsidence)
- Implant fracture
- Severe pain
- Joint inflammation and swelling
- Nerve damage
- Bone loss (osteolysis)
- Bone spurs or abnormal bone growth
- Loss of flexibility
- Problems walking
- Revision surgery
- Needing other surgeries to fix complications
Patients May Need Multiple Revision Surgeries
When the Cartiva toe implant fails, patients typically need revision surgery. This surgery is painful, costly, and time-consuming, but it is usually necessary if the implant is causing pain or damaging the joint.
Patients may actually need multiple surgeries to removing the Cartiva implant, fix complications, or fuse the toe joint. Some patients are also left with permanent mobility problems that can lead to increased pain in other areas of the body, such as the hips, knees, or lower back.
Cartiva Toe Implant Lawsuits
More than a dozen Cartiva toe implant lawsuits have been filed by patients who accuse the manufacturer of failing to warn them about the true risks of this device. These lawsuits claim that Stryker knew (or should have known), but instead put profits over patient safety.
Can I File a Lawsuit?
You may be eligible to file a lawsuit or join a class action if the following applies:
- You currently have (or used to have) a Cartiva toe implant
- Your implant failed or is causing serious complications
- You needed revision surgery to remove the Cartiva implant
- OR your doctor is recommending surgery
Need a Cartiva Toe Implant Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.