The U.S. Food and Drug Administration (FDA) has officially announced that the Infuse bone graft and other bone graft systems are unsafe for pediatric patients. On Jan. 21, 2015, the FDA stated that children under the age of 18 should not be treated with this medical device because of the potential bone graft complications they could suffer in adulthood.

In the safety announcement, the FDA explained that only specific patients should be allowed to use bone grafts for specific spinal and dental surgeries, which are only approved by the agency. Additionally, only patients who are “skeletally mature” or have completed their growth should use bone grafts, because bone graft complications can occur in developing spines. The FDA’s medical experts state that patients who are over 18 have completed their skeletal development and would be able to handle the bone graft process.

The FDA continued on in its explanation by mentioning several side effects that pediatric patients suffered after using bone graft products. These young patients typically suffered rare bone growth disorders and required extreme medical remedies. Unfortunately, the patients experienced ectopic bone growth, fluid accumulation, inhibited bone healing, and swelling. While these side effects also occurred in adult patients, the FDA found the pediatric patients more concerning because these injuries could have permanent side effects that follow these patients into adulthood.

Furthermore, the FDA’s warning specifically addressed Medtronic’s Infuse Bone Graft, stating that it now may be liable for any pediatric patients who used the Infuse Bone Graft System. Considering that a number of Infuse Bone Graft injury reports were from patients who used the product for an off-label purpose, after Medtronic Inc. allegedly advertised Infuse for such purposes.

Ultimately, the FDA advised healthcare providers to find alternative bone graft remedies for pediatric patients. Sadly this does not change the fate of the patients, pediatric or otherwise, who have already suffered the complications from Infuse or other bone grafts.

Overview of Infuse Bone Graft Complications

The Infuse Bone Graft is made up of synthetic bone morphogenetic protein (rhBMP-2) and a sponge material made from cow collagen. It is designed to be directly implanted into the damaged portion of the spine, making it less invasive than harvesting extra bone marrow from another area of the body. It allows for less hospital recovery time and is not as invasive, compared to traditional spinal fusion surgery.

Bone graft systems, like Infuse, become necessary if a patient has suffered some form of spinal damage, which requires stimulating or implanting bone marrow when it is needed. This has become widely popular among patients who need spinal fusion surgery because it is less invasive and requires less hospital recovery time. However, many companies, like Medtronic, are marketing bone graft systems for off-label purposes, thus opening the doors to bone graft complications including immobility, severe pain, and ectopic bone growth. This practice has led to bone graft systems like Medtronic’s Infuse to gain an adverse reputation due to the bone graft complications many patients have reported.

As previously mentioned, Medtronic Inc. came under fire for allegedly marketing the Infuse Bone Graft for off-label purposes. Infuse was originally approved in 2002 to treat specific lower lumbar procedures that were approved by the FDA, but Medtronic had allegedly claimed Infuse could be used on the cervical area of the spine when it was not approved to do so. This has led to a long list of allegations and injury reports that patients claimed were a direct result of using the Infuse Bone Graft.

In 2011, the U.S. Senate launched an investigation against Medtronic, after hearing of these allegations. It was found that the company had paid doctors to write positive reviews of the Infuse Bone Graft System in medical journals, and neglected to mention the dangerous side effects. The company had also reportedly set up fraudulent agreements and royalty arrangements, which involved kickbacks to the doctors who used the Infuse Bone Graft System. While Medtronic settled the case, it is now facing a number of Infuse bone graft lawsuits from those who allegedly suffered bone graft complications using the Infuse bone graft system.