Toe Implants
As people get older, they often develop arthritis. When arthritis develops in a person’s foot, it can impact their ability to get around and their overall mobility. One of the most common forms of arthritis is hallux rigidus, or big toe arthritis, which occurs at the base of a person’s big toe. This condition often causes excruciating pain. Many sufferers undergo toe fusion surgeries to alleviate the pain, but fusing two toes together could reduce their mobility.
In recent years, people have had the option of choosing big toe implant surgery, which is supposed to reduce pain and leave people with almost full mobility. However, the implants can cause additional problems, resulting in further pain and injury.
Cartiva Toe Implants
In 2016, Cartiva, Inc. sought FDA approval for its new product to treat big toe arthritis – the Cartiva Synthetic Cartilage Implant. The Cartiva Implant involved a small, hydrogel implant (made of the same substance as a contact lens) being surgically implanted inside the base of the big toe. The implant would sit several millimeters proud and was supposed to mimic the feel of natural, human cartilage, doing away with the bone-on-bone contact that was causing the patient’s pain and limited mobility and allowing the patient to freely move the joint.
The MOTION Study
To obtain FDA approval, Cartiva commissioned the MOTION study, a prospective, non-inferiority study evaluating the Cartiva implant as compared to the gold-standard fusion. The authors of the MOTION study concluded that Cartiva provided equivalent pain relief and functional outcomes and was an “excellent alternative” to a fusion where patients wished to maintain motion in the great toe. Critically, the MOTION study found that less than ten (10%) of those implanted with Cartiva failed within the first two years.
Unfortunately, these results were not replicated in patients outside of the trial. Thousands of patients began receiving the Cartiva implant, hopeful they would be able to retain their range of motion, run marathons, and wear shoes of their choice. However, the true failure rate of the Cartiva proved to be far higher, and countless patients have suffered, often undergoing additional surgeries to remove the Cartiva, graft the bone loss cause by the Cartiva implant procedure, and have the joint fused.
How Do Cartiva Toe Implants Work?
People undergo toe implant surgery to relieve pain. Cartiva implant surgery is a minimally invasive procedure and the recovery time was not expected to be as long as with traditional surgeries. With implant surgery, doctors install a synthetic implant into the big toe joint, which acts like human cartilage. It allows people to move their implanted joint freely, meaning that a person should be able to resume their normal activities after a successful surgery.
If a patient experiences problems after their toe implant surgery, they should consult with their doctor who could come up with a treatment plan to help relieve their pain. After consulting with their doctors, they may also seek legal assistance to see if the Cartiva toe implant failed and compensation may be appropriate.
A team of dedicated lawyers has experience reviewing medical records and could help a patient better understand the results of their surgery, future expected prognosis, and the likelihood of success with a legal claim.
Cartiva Toe Implant Failures
Since 2016, many patients across the U.S. suffering from big toe arthritis have received the Cartiva implant. Despite the company’s promise that the implant alleviates the pain and mobility restrictions associated with bone-on-bone arthritis, the implant has failed in many patients, resulting in further pain and injury. Indeed, one company designed a product specifically to address failed Cartiva implants naming it after the device, spelled backwards.
Potential Problems with Cartiva Implants
Clinical trials predicted that the Cartiva surgery’s results would be superior to traditional toe fusion surgeries. However, actual patients had more difficulties than expected with the surgery. The surgeries have not been as successful at alleviating pain or increasing mobility for many patients. In addition, several patients have more pain and foot problems from Cartiva.
Common indications a Cartiva implant may be failing include:
- Subsidence
- Implant slippage
- Pain in the joint
- Grinding
- Limited mobility
- Gait affect, such as limping or favoring the other leg
- Cartiva revision and removal surgeries
The Cartiva implant is very smooth and the smoothness of the synthetic implant could cause it to slip. The device is also prone to subsidence. This means it can cave or slip directly into the attached bone. The causes intense pain and mobility issues when subsidence occurs. Some doctors also believe that the device is not very durable and does not hold up well over time, leading to future problems.
Significant Consequences
Many patients with these implants will eventually need additional surgeries to remove the implants or fix the problems. This leads to further pain. The final stop appears to be a fusion of the two bones in the big toe. Here’s what AI created as an image for Arthrodesis of the Big Toe Joint. Put simply, the surgeon attaches the two bones in the big toe.
In many cases, undergoing a fusion after a failed Cartiva is a more difficult surgery with less favorable results than if the patient would have received a primary fusion. This can result in patients undergoing third and fourth surgeries following a failed Cartiva, hardware removal surgeries, and complications due to infection.
Economic Losses on Top of Pain and Suffering
Patients might need to take time away from their jobs while they heal. That lost income may be compensable. The device can also cause unnecessary medical expenses and related economic losses. When third parties cover the cost of these medical treatments, they can have a right to subrogation or a lien, which can come from the injured party’s recover in a lawsuit or claim.
A knowledgeable Cartiva toe implant attorney could help an injured patient recover compensation for this defective product and navigate these complex legal waters.
If Your Cartiva Implant Hasn’t Stopped the Pain or Given Returned Range of Motion, Seek Medical Attention and Consult KBA
If a big toe surgery involving a Cartiva toe implant has caused you problems, you might be eligible to seek compensation or file a Cartiva toe implant lawsuit. Problems include persistent or worsening pain or limited mobility. In such situations, patients should first consult with their doctor to come up with a treatment plan. They may also Contact Us – KBA Attorneys to see if there may be a legal claim related to the failure of the Cartiva implant.
Status Update
From time to time we see lawsuits filed. Seems few and far between. Another just hit the news in April 2024, Orthopedics Maker Faces Migrating Arthritis Implant Lawsuit (bloomberglaw.com). Our analysis is that this lawsuit presents the same complaint as another law firm filed a year or so ago, not much new other than another person hurt by the device.
Learn More About Cartiva Toe Implants from KBA Attorney, Whitney Butcher
KBA Attorneys have an excellent partner working on Cartiva cases, Whitney Butcher (kbaattorneys.com). Ms. Butcher is a medical device trial attorney at KBA with experience in all aspects of medical device lawsuits.
Whitney works with KBA’s experts regularly. She learns the science and medicine to understand how they operate within our legal system. She is leading the Cartiva toe implant matter at KBA with a client-centered focus rooted in the law and cutting-edge strategies to bring clients’ cases to life.
If you believe you are worse after a Cartiva toe implant surgery, call your physician first. Then call us. A seasoned attorney can review your legal options and we can educate you about Cartiva. These implants are medical devices and present complex legal issues. The attorneys at KBA are experienced medical device lawyers. You might be eligible to seek legal relief against the manufacturers of the defective implant that caused you harm. Contact us today to find out.
An attorney may be able to help you obtain damages to compensate you for your physical, emotional, and financial losses arising from the defective implant. Contact us to reach our skilled, compassionate legal team today to learn how to get started on your potential case.
