What is Stryker OP-1 Putty?
Manufactured by Stryker Biotech, OP-1 Putty is a surgical putty in a class of devices known as Bone Morphogenetic Proteins (BMP), which are used to promote bone growth. Unlike medical devices that are approved by the FDA after being deemed safe and effective, Stryker OP-1 Putty was approved in 2004 as a “humanitarian use device.” This means that Stryker OP-1 Putty’s effectiveness has not been established, and the device can only be used to treat rare conditions. Even then, it could only be used as specified by the FDA. It also means that permission to use Stryker OP-1 Putty on a patient must be granted by an Institutional Review Board (IRB) prior to use and only after receiving the patient’s consent.
What is Calstrux?
Also manufactured by Stryker Biotech, Calstrux is a bone void filler that is used in orthopedic surgery. It can be used when someone sustains an injury or when a surgical procedure results in a gap in the bone. Stryker Biotech was indicted in 2009 for failing to inform surgeons about possible side effects from Calstrux, such as the device migrating to different parts of the body and growing bone in potentially problematic or dangerous places.
Off-Label Use of Stryker OP-1 Putty and Calstrux
In January 2012, Stryker Biotech pleaded guilty to a misdemeanor and paid a fine of over 15 million dollars for illegally marketing the use of OP-1 Putty. Stryker, through its sales representatives, was charged with encouraging surgeons to mix OP-1 Putty with Calstrux even though the mixture had never been formally tested in clinical trials and had not received FDA approval. This illegal promotion is referred to as “off-label marketing,” and Stryker used this tactic to get surgeons to use the mixture of Stryker OP-1 Putty and Calstrux without establishing the safety and effectiveness of the treatment. Stryker medical sales associates were also charged with falsifying hospital records in order to authorize the use of Stryker OP-1 Putty.
Symptoms Associated With Stryker OP-1 Putty and Calstrux Mixture
- Excessive bone growth
- Migration of bone growth
- Nerve compression
- Severe pain
- Repeated surgeries
- Death (in rare cases)