The FDA approved the Infuse Bone Graft manufactured by Medtronic specifically for lumbar spine procedures. But according to recent whistleblower and personal injury lawsuits, the company has allegedly marketed the Infuse Bone Graft for use in the cervical spine. The off-label use of the bone graft has caused ectopic bone growth for several patients. Even before the product was approved for sale, there had been concerns regarding safety, and the FDA approved use of the Infuse Bone Graft for patients with very specific cases. However, the off-label misuse of the product has caused severe damage in numerous patients. If you have been treated with the Medtronic Infuse Bone Grafts and have suffered from ectopic bone growth, please contact an attorney regarding your right to take legal action.
Medtronic Infuse Bone Graft
While the bone morphogenetic protein-2 being developed by Medtronic was still undergoing clinical trials, CT scans revealed that 70 percent of patients developed unwanted bone growth within a few months of treatment. But rather than acknowledging the dangers, the study was finally published in 2004 by doctors with financial ties with Medtronic, downplaying the dangers of the excessive bone growth, called ectopic bone formation. After it’s approval by the FDA, doctors, especially those that have received severances from Medtronic, illegally promoted the product for off-label use, causing serious complications in patients trying to recover from spinal injuries.
Symptoms of Ectopic Growth
Identifying ectopic bone growth early is a crucial part of increasing the patient’s chances of a full recovery. Signs and symptoms of ectopic growth due to off-label use of Infuse Bone Graft include:
- Loss of sensation
- Reduced range of motion
- Swelling and other inflammatory responses
- Respiratory problems
- Nerve damage.
Patients who suspect complication are encouraged to contact their doctors immediately. The abnormal bone growth can usually be identified with an X-ray or CT scan.
Medtronic Product Liability
Medtronic has not only released a product that had shown dangerous side effects, but may have also had a hand in the widespread misuse of the product. There have been more than 280 reports of adverse events filed with the FDA, most of which (75 percent) involve off-label use of the Infuse Bone Graft. Spinal cord injuries are difficult to recover from even without the added injuries the graft can cause. Patients who have been harmed by Medtronic’s blatant disregard for safety have a right to seek compensation for related:
- Medical bills
- Lost wages
- Pain and suffering
- Reduced earnings capacity.
Seek Legal Help
Large companies like Medtronic have extensive resources available to them to protect their products and brand. If you are considering legal action, it is important to have the professional legal representation of a defective medical device lawyer who has the legal skills and finances to ensure you are not made to settle for anything less than you deserve. The Medtronic Infuse lawyers at Estey Bomberger can help you secure the compensation you are entitled to by aggressively negotiating and defending your rightful claim. For a free case evaluation, please contact us today.