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Cartiva® implant details: The background and development of a dangerous medical device
Wright Medical paid a reported $435 million to acquire Cartiva® last year–and, 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.
With almost the same size and shape of a mini-marshmallow, the Cartiva® implant is made from saline solution and polyvinyl alcohol -- the same material as in soft contact lenses.
Other benefits the company has touted include:
- The reduction of joint pain without sacrificing the foot's natural movement;
- The retention of the patient's mobility and range of motion; also,
- Patients typically return to function and daily activities faster than patients who undergo a fusion procedure, due to a less restrictive rehabilitation protocol.
The Cartiva® implant is composed of a biocompatible, durable, low-friction organic polymer designed to function similarly to natural cartilage, and it can be implanted in about 35 minutes–plus, the material compresses and expands much like real cartilage.
Cartiva® implant dangers: Why this dangerous medical device is an injury waiting to happen
Cartiva®'s pivotal trial, known as the MOTION trial, showed statistically significant higher pain scores with Cartiva®, including a Cartiva® case series with mixed results and numerous online complaints from dissatisfied Cartiva® patients.
The following conditions make the Cartiva® medical implant an eventual danger to patients:
- Smooth implant surface. The Cartiva® implant is made of an inert substance that shows very little reactivity in the body–so, because the implant is very smooth on all surfaces, it creates a functional flaw in the design that may lead to serious injury post-operation.
- Violation of the subchondral plate. The loss of the subchondral plate support with no alternative means of support places the Cartiva® Implant into the soft metaphyseal bone and is prone to impaction failure.
- Lack of osseointegration. Osseointegration, or ingrowth of bone into the implant is described as an essential aspect of implant stability.
- Placement in bone too soft for support. The supporting bone is too weak to provide meaningful, long-term support to resist the load applied to the implant.
According to Mike Matson, a medtech analyst at Needham & Co.: "While some of the patients are satisfied with Cartiva®, a majority are dissatisfied with many citing pain that lasts longer than they expected."
The USA Assistance Team believes that patients that received a Cartiva® implant and then suffered a serious medical injury diagnosis should be able to seek justice and compensation from the manufacturer in a court of law.
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