Cartiva Toe Surgery Linked to Persistent Pain, Limited Range of Motion, Other Complications: Study

Individuals who undergo Cartiva toe surgery often face persistent pain, swelling, stiffness and the need for revision surgery, according to the findings of a new study, which warns that doctors have not yet figured out which patients are the most likely to benefit from the implant.

Researchers from the U.K. found that nearly half of all Cartiva toe implant patients suffered complications, and nearly 20% had to undergo reoperations or revision surgery. The findings were published in the medical journal Cureus on November 19.

The Cartiva SCI is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted as a revolutionary toe implant since it was introduced. However, within a few years concerns have emerged about alarming toe implant failure rates, which have caused patients to experience widespread complications, including reports of severe toe pain, loosening, fracture and other problems, often resulting in the need for a surgery to fuse the big toe.

As a result, the manufacturers now face a growing number Cartiva toe surgery lawsuits over failure to disclose known risks associated with the device.

Cartiva implants have been sold as a revolutionary new treatment option for arthritis that has caused cartilage in the big toe joint to degrade, known as hallux limitus or hallus rigidus, which impacts about 2.2 million people in the U.S., and results in severe pain.

The synthetic cartilage implant is designed to provide cushioning to replace the degraded cartilage and provide pain relief, and is considered an alternative to fusing the joint, a procedure known as arthrodesis, which has a longer healing time and is a more complicated surgical procedure.

High Rates of Cartiva Toe Implant Complications

In this latest study, researchers reviewed 22 Cartiva toe surgery procedures between 2016 and 2022 at a hospital in the U.K. They looked for peri-operative complications, implant survival, patient-reported outcomes, functional improvements, and if there were any additional surgeries or interventions needed.

According to their findings, the total complication rates from Cartiva toe surgery, including medical, surgical, and implant complications, were 45.5%, or nearly half. The researchers noted that, at final follow-up, 55% still experienced pain, 15% suffered from neurovascular symptoms, 50% suffered from stiffness or reduced movement, and 10% suffered from swelling.

The researchers noted that the rates of persistent post-operative pain often lead to the need for additional therapies, such as orthotics, debridement and implant repositioning. Four out of the 22 patients, 18.4%, had to have additional surgeries, including two cases of revision surgery to remove the Cartiva toe implants.

Complications included stitch abscesses, superficial infections, oozing wounds, and skin blistering, the researchers noted. They pointed out that the studies they reviewed found only 36.4% of Cartiva toe surgery patients reported being satisfied with the procedure, while 27% reported dissatisfaction.

“The evidence fails to show a significant difference in the benefit of SCI surgery… with other studies demonstrating no difference in benefit between Cartiva and arthrodesis regarding hallus rigidus or hallux valgus severity, gender, age, BMI, symptom duration, prior procedures or intensity of pre-operative pain,” the researchers determined. “The consensus as to who would benefit the most from SCI surgery is still debated and further clarification is required.”

Cartiva Toe Implant Lawsuits

Although the manufacturer suggested the Cartiva failure rates were low, a number of product liability lawsuits point to a study published in November 2020, which found that as many as 64% of individuals who received a Cartiva implant for hallux rigidus experienced failure within four weeks of surgery, and the failure rate increased to 79% after 19 months.

Some reports also suggest that Cartiva failures have left individuals in a much worse position, due to the amount of bone removed during the toe implant surgery. In this scenario, patients have been left with significantly shorted big toes, which can lead to additional foot injuries from the offloading effect.

Such poor patient outcomes will likely result in many more implant recipients seeking settlements or compensation from the manufacturer through the filing of a Cartiva lawsuit, alleging that the manufacturer did not uphold their duty to adequately investigate that the devices were safe and failed to warn patients about the increased risk of implant failure.