Stryker's OP-1 Putty Calstrux Mixture Dangerous to Patients and Not Approved by FDA
Stryker’s OP-1 Putty, Calstrux Mixture Not Approved by FDA
OP-1 Putty, which Stryker Biotech manufactures, is a surgical putty in the medical device class called Bone Morphogenic Proteins (BMPs); it is designed to promote bone growth. It was approved by the Food & Drug Administration (FDA) in 2004 under a highly restrictive Humanitarian Device Exemption. One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit.
Calstrux, which also is manufactured by Stryker Biotech, is a bone void filler used in orthopedic surgery, when someone is injured or a surgical procedure creates a hole in bone. Stryker Biotech was indicted in 2009 for failing to inform surgeons about possible side effects from Calstrux, which include the device migrating to different parts of the body and growing bone in potentially problematic or dangerous places. According to prosecutors, the defendants promoted the OP-1 products in a mixture with Calstrux because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products. The indictment also alleges that serious medical problems arose in a number of patients from this untested mix of products.
Side Effects of OP-1 Putty and Calstrux Mixture
In January 2012, Stryker Biotech pleaded guilty to a misdemeanor and paid a $15 million fine for illegally marketing the “off-label” uses of OP-1 Putty. Stryker sales representatives were encouraging surgeons to mix OP-1 Putty with Calstrux, which had never been formally tested and was not approved by the FDA. Also, Stryker medical sales associates were charged with falsifying hospital records to authorize the use of OP-1 Putty.
Symptoms linked to using a mixture of Stryker OP-1 putty and Calstrux:
- Excessive bone growth
- Migration of bone growth
- Nerve compression
- Severe pain
- Death (in rare cases)
Case Study of Stryker OP-1 Putty and Calstrux Mixture Recipient
April Cabana went to the hospital for back surgery in 2008; it was supposed to be a routine procedure, the then-34-year-old was told; an everyday spinal fusion, completed via conventional surgical methods.
But none of that happened. Instead Ms. Cabana was implanted with a mixture of two Stryker medical devices, OP-1 Putty and Calstrux. She was not made aware of this, and she certainly did not offer her consent. And she wasn’t alone. In fact, she was allegedly one of 17 patients operated on in this manner by Pomona Hospital between 2006 and 2011.
Ms. Cabana survived what can be called experimental surgery, but she is not the same, having sustained life-altering and debilitating injuries, such as the unwanted growth of bone in her back, which compressed nerves and caused agonizing pain.
Ms. Cabana was forced to undergo revision surgery to remove the excessive bone growth. But the procedure was not successful and actually wound up causing her even greater pain. She is now permanently disabled. (The names and conditions of the other 16 patients are not known.)
Legal Help for Victims of Stryker Off-Label Complications
If you or someone you know sustained an injury due to off-label use of the mixture of Stryker’s OP-1 Putty and Calstrux, you have valuable legal rights. To learn how our lawyers can help you, please fill out our online form, or call 1-800 YOURLAWYER (1-800-968-7529) to discuss your case with one of our experienced lawyers.