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Cartiva® implant details: Background and development of a possibly dangerous medical implant device
The FDA approved the Cartiva® Synthetic Cartilage Implant (SCI) in July 2016 for treating mid-stage to advanced arthritis at the base of the great toe.
In 2018, Wright Medical paid an estimated $435 million to acquire Cartiva®.
The Cartiva® Synthetic Cartilage Implant (SCI) is composed of saline solution and polyvinyl alcohol, which is the same material found in soft contact lenses–and it’s almost the exact same size and shape of a mini-marshmallow.
The company has touted a variety of benefits that include:
- The reduction of joint pain without sacrificing the foot's natural range of motion;
- The retention of the patient's mobility and movement; also,
- Patients may return to daily activities faster than patients who undergo a traditional fusion procedure, because of a less restrictive rehabilitation protocol.
Composed of a biocompatible, durable, low-friction organic polymer, the Cartiva® Synthetic Cartilage Implant (SCI) is designed to function muchi n the same way that natural cartilage does because it compresses and expands very similarly to real cartilage.
Plus, the Cartiva® Synthetic Cartilage Implant (SCI) can be implanted in about 35 minutes.
Cartiva® implant dangers: Why this dangerous medical implant device could be an injury waiting to happen
Known as the MOTION trial, Cartiva®'s pivotal trial showed significantly higher pain scores, including a case series with mixed results and numerous online complaints from dissatisfied implant patients.
The following characteristics make the Cartiva® Synthetic Cartilage Implant (SCI) a potential danger to patients after surgery:
- Smooth implant surface. Because the Cartiva® Synthetic Cartilage Implant (SCI) is very smooth on all surfaces, there exists a functional flaw in the implant design with the potential to lead to serious injuries post-operation.
- Subchondral plate violation. Without subchondral plate support and with no alternative means of support, the Cartiva® Synthetic Cartilage Implant (SCI) must be fixed into the soft metaphyseal bone–this could make it prone to impaction failure.
- Little to no osseointegration. Ingrowth of bone into the implant is required as an essential aspect of implant stability–the absence of which is detrimental to surgical success and life after implant.
- Placement in soft bone offers little support. Implant of the Cartiva® Synthetic Cartilage Implant (SCI) into the supporting bone makes the entire structure too weak to provide the meaningful, long-term support required to resist the load applied to the implant.
“While some of the patients are satisfied with Cartiva®, a majority are dissatisfied with many citing pain that lasts longer than they expected," reveals Mike Matson, a medtech analyst at Needham & Co.
The Shield Justice Online team believes that patients that received a Cartiva® Synthetic Cartilage Implant (SCI) and then was diagnosed with a serious medical injury should be able to seek justice and compensation from the manufacturer in a court of law.
Our network of attorneys have a track record of success.
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Please seek the advice of a medical professional before making health care decisions. This advertisement is not associated with Cartiva® or any government agency.
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