Cartiva Big Toe Implant Lawsuit

All surgical procedures, regardless of how simple or complex, carry an element of risk. People having surgery should be made aware of the health risks and the rate of success of the procedure, allowing them to decide whether they should go ahead with it or not. Both of these elements – patients knowing the risks and rate of success – are acutely relevant to the current Cartiva toe implant lawsuits. Cartiva, a medical device company specializing in implants to treat osteoarthritis, offered an implant solution to treat big toe arthritis, a type of arthritis suffered by around 1 in 40 Americans over the age of 50. However, after undergoing the surgery, many patients experienced problems with the implant, seeing their pain increase and suffering other long-term health issues. Above all, the success rate of the implant seems to be much lower than studies overseen and advertised by Cartiva, with a 2020 study by the American Orthopedic Foot and Ankle Society showing that up to 79% of Cartiva big toe implants fail after 19 months, causing heightened pain in patients and forcing some of the recipients of the implant to have corrective surgeries. Those who underwent the procedure are now fighting back, filing lawsuits against Cartiva that allege the company has created a defective product that puts patient health at risk.

Cartiva, founded in 2011, offers what it promotes as a revolutionary way to treat big toe arthritis through its Cartiva Synthetic Cartilage Implant (SCI) procedure, which gained FDA approval in July 2016. As an alternative to joint fusion surgery, which is considered a more complex surgery, Cartiva’s procedure uses a synthetic cartilage implant to replace the cartilage in the arthritic big toe. The implant is made of PVA (polyvinyl alcohol), formed as a gel-like substance. The idea is that it mimics the natural bone structure, so, in theory, it should be much more comfortable than other implant materials, for example, a metal implant. The SCI procedure can be carried out in around 35 minutes. These factors contributed to the initial success of Cartiva as a company, prompting it to be bought out by Wright Medical for $435 million in July 2018. However, many patients have reported problems with Cartiva implants, leading to claims that the product is defective and was falsely promoted as being safe. As such, 100s of lawsuits have been filed against Cartiva manufacturers. This includes the parent of Wright Medical, which was purchased by Stryker Corporation in 2020.

• August 1, 2024 - Litigation involving the Cartiva synthetic cartilage implant, used in treating arthritis in the big toe, is ongoing. Plaintiffs allege complications and failures with the implant, leading to further medical issues.
• June 1, 2024 - Wright Medical Buys Cartiva to Boost Lower Extremities Unit.
• February 1, 2024 - Arthrodesis vs arthroplasty for moderate and severe Hallux rigidus.
• January 1, 2024 - The Cartiva Synthetic Cartilage implant led to restrictions in the use of big toe.
• December 1, 2023 - FDA Post-Approval Studies (PAS) Database: Cartiva, Inc - Cartiva Synthetic Cartilage Implant.
• July 1, 2023 - Cartiva Implant Surgery: This leaflet explains the Cartiva implant procedure to treat arthritis in the big toe joint, also known as hallux rigidus.
• June 1, 2023 - Cartiva Inc. - Company Profile and news - The Company manufactures cartilage implants, synthesized polymers, hydrogels, and other products for cartilage repair and joint relief. Cartiva has customers in over 100 countries.

Cartiva is a cartilage implant made of synthetic material that is used for treating arthritis in the joint of the big toe, also known as hallux rigidus. Cartiva implants are effective at relieving pain for many patients and improving joint function. However, as with any medical device or procedure, they can fail or cause complications. Cartiva implants can fail and cause complications.

Device Wear and tear

The Cartiva implant can wear out over time. This may lead to a decrease in effectiveness for cushioning the joint, and reducing the pain. The big toe can become stiff and painful again.

Infection

As with any surgery, infection can occur after Cartiva implant surgery. Infections can cause swelling, pain and redness. They may also require the removal of the Cartiva implant.

Device Dislocation or Migration

Cartiva implants may move or shift from their original position in the joint. This can cause discomfort and reduce the implant's effectiveness.

Allergic reaction or hypersensitivity

Certain individuals may experience allergic reactions or hypersensitivity due to the materials in the Cartiva Implant, resulting in inflammation, pain and other complications.

Cartiva Implants may not alleviate pain in all patients

Cartiva implants were designed to improve joint function and reduce pain, but they might not achieve the desired result for some patients. Some patients may still experience pain or limited mobility after the implant.

Scar tissue formation

After the Cartiva implant is placed, it can cause excessive scar tissue to form. This may limit joint movement and cause discomfort.

Revision Surgery may be required if the Cartiva implant fails, or if complications occur.

You or your loved one may be eligible for compensation if you suffered complications following a Cartiva joint implant. Select Justice may be able to help you recover compensation if:

• Medical expenses - past and future
• Pain and suffering in the past and future;
• The loss of wages.
• Additional economic losses resulting from your injury

The Cartiva implant can fail for a number of reasons including those related to the design of the implant. One such problem is termed subsidence, which essentially means the synthetic cartilage has slipped into the bone. This can cause a world of problems, including heightened pain and exasperation of the initial arthritis symptoms. As a result, many of those patients who have had failed Cartiva implants have had no choice but to remove the implant, often in conjunction with follow-up surgery to insert a conventional metal implant.

What are the symptoms of Cartiva implant failure? Those who have had the procedure may feel increased pain, movement problems in and around the big toe, stiffness, irritation, inflammation, infection, nerve damage, and permanent bruising.

The key issues in the Cartiva implant lawsuit seem to lie in the disparity between the rate of failure in independent studies and those studies sponsored by Cartiva. There have been several investigations that have come up with widely varied success rates, ranging from 20% to 50%. One of the most comprehensive studies, published by the American Orthopedic Foot and Ankle Society, showed a 64% failure rate after four weeks and a 79% failure rate after 19 months post-surgery. Regardless, they are much lower than the 86.5% success rate promoted by Cartiva.

Problems with Cartiva implants have been a common topic of discussion on patient internet forums. While some patients have reported no Cartiva implant problems post-surgery, there is a growing consensus that the success rate is much lower than that purported by Cartiva and that many patients do suffer from implant problems. This is one of the driving factors behind the Cartiva big toe implant lawsuits.

Of all the complications reported with Cartiva implants, subsidence – the synthetic cartilage slips into the bone – seems to be the most common adverse event. This will usually cause severe pain in the big toe, and it normally requires corrective surgery. Other reported Cartiva complications include fragmentation/implant fracture and misalignment (the implant breaks up or moves), infection, foreign body reaction (the body rejects the implant), osteolysis (destruction of bone tissue), joint removal, cysts, and heightened pain.

Cartiva implant infection is among the most common side effects, cited in around 14% (according to one study) of patients who have had an adverse event relating to the procedure. Importantly, the FDA points out that infection is often caused by other Cartiva complications and adverse reactions, such as the fragmentation of the implant.

The Cartiva big toe implant gained PMA (Premarket Approval) from the FDA in August 2016. This was the first-ever approval for a cartilage implant for osteoarthritis.

There has not yet been an FDA recall for Cartiva. However, the government agency has updated its website to highlight the reports of adverse events related to the implant procedure.

If you have had a Cartiva implant, then you may be eligible for compensation through the Cartiva lawsuits. Qualifying factors will include having an adverse reaction to the implant, including suffering increased pain, infection, loss of mobility or any of the other Cartiva complications mentioned previously. There are also economic factors, including the cost of corrective surgery, loss of earnings through missing work, and any other past, present, or future medical expenses. If any of these apply to you, then you could be eligible to join the Cartiva big toe implant lawsuits. Speak to a lawyer for more information on how you could be due compensation.

At the moment, the Cartiva lawsuits have not been consolidated into a mass tort or class action lawsuit. However, it is highly possible that the lawsuits will be combined into a single action for reasons of expediency, particularly if more people come forward claiming damages due to defective Cartiva implants.

What is a Cartiva big toe joint implant?

The Cartiva big toe joint implant is a synthetic implant used to treat big toe arthritis. The procedure is performed as an alternative to joint fusion surgery.

Why does Cartiva fail?

Reports have cited that the Cartiva implant has failed for a variety of reasons. Most notably, there is the issue of the implant slipping into the bone (subsidence), breaking up, or moving. This can lead to other complications, including increased pain and infections.

How long does Cartiva implant last?

The implant is supposed to last indefinitely. However, it’s important to point out that Cartiva implant is a relatively new procedure (first gaining FDA approval in 2016), so data for long-term health outcomes is not yet available.

Is Cartiva FDA approved?

Yes. Cartiva gained FDA approval. However, the FDA has updated its guidance to provide warnings of risks associated with Cartiva implants.

How successful are Cartiva implants?

This is a bone of contention. Initial studies sponsored by Cartiva claimed a success rate of around 87%. Yet, other studies have shown success rates of around 20%. This discrepancy is a key factor in the Cartiva implant lawsuits.

How to lessen pain from Cartiva?

If you are experiencing pain from Cartiva implant surgery, you should contact your healthcare provider for more advice. 

Who manufactures Cartiva implant?

Cartiva was acquired by Wright Medical in 2018, which was in turn acquired by Stryker in 2020. However, it still operates under the Cartiva brand name, and all manufacturers of Cartiva are cited in the lawsuits.