Medtronic’s Infuse Bone Graft, a potent substance used in spine-repair surgery to promote bone growth, has been linked to life-threatening complications in dozens of patients. The Wall Street Journal reports that many of the potentially deadly reactions have occurred during “off label” uses, when surgeons use it in ways that haven’t been approved by the Food and Drug Administration.
The FDA warned surgeons in July that it had received reports of life-threatening complications associated with using the product in surgeries on the cervical spine, around the neck. The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries, according to reports filed with the agency, the Journal reports.
The FDA’s alert about Infuse was specific to neck surgeries. But a review of FDA records and medical literature shows there have been scores of other cases in which serious complications arose after the product was used in other off-label situations. Many of these cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites. That can lead to pain, repeat surgeries and, in some cases, emergency intervention.
Three “whistleblower” lawsuits brought by former employees have alleged illegal marketing, seeking refunds for the federal government on Medicare and Medicaid payments to the company, the Journal reports. The former employees, who share in any recovery under federal law, asserted in the suits that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, which were filed in federal district court in Memphis, Tenn., without admitting wrongdoing.
One of the whistleblowers has challenged the company’s agreement with the federal government, saying the sum is too small. The lawsuit that hasn’t been settled was filed last year in federal district court in Boston by two former Medtronic employees. It alleges that the company illegally marketed Infuse for off-label purposes through doctors who were paid inflated consulting fees and bogus royalty payments. Marketing off-label uses is not allowed under FDA regulations.