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Cartiva® implant device details: The background and development of a hazardous medical 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–and then in 2018, Wright Medical paid a total of $435 million to acquire Cartiva®.
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.
The Cartiva® Synthetic Cartilage Implant (SCI) is advertised with a variety of benefits that include:
- A reduction of overall joint pain without sacrificing the foot's natural movement;
- The retention of the patient's complete mobility and range of motion; also,
- A patient might possibly return to normal activities faster because of a less restrictive rehab 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 device dangers: What makes this a potentially dangerous medical implant device
The Cartiva® Synthetic Cartilage Implant’s (SCI) pivotal trial demonstrated much higher pain scores, as well as a case series with obvious mixed results and a great deal of online complaints from dissatisfied implant 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.
“While some of the patients are satisfied with Cartiva®, a majority are dissatisfied with many citing pain that lasts longer than they expected," explains Mike Matson, a medtech analyst at Needham & Co.
The Direct Case Justice 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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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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