Medtronic is in trouble regarding its Infuse spine surgery product which was approved by the FDA in 2009 but has remained controversial for its off label implementation. About 85% of Infuse use is off-label. A U.S. Senate committee has now also launched an investigation into reports that doctors with financial ties to the medical device company were aware of potentially serious complications when using Infuse.
Medtronic was warned sternly this week not to destroy or make inaccessible any of the documents, data or other related information in the letter signed by committee chairman Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa).
Over the last year a series of medical watchdog journals have raised questions about annual payments made to a core of prominent surgeons around the country who were involved either in the clinical testing of Infuse or co-authoring positive medical journal articles that failed to link the product to serious complications.
Supposedly, last year alone three of the paper’s four authors got about $4 million in various royalty payments from Medtronic. Uh oh.
Baucus and Grassley further wrote in their letter to Medtronic:
“We are also concerned that other severe side effects of Infuse and similar bone-growth products developed by Medtronic may have been unreported or under-reported in clinical literature. Reports have linked Infuse to potentially fatal swelling in the neck and throat and radiating leg pain.”
Infuse has been linked to a variety of other complications since it was approved. Medtronic’s website lists “sexual dysfunction” as one possible risk associated with spinal surgery but does not connect it specifically to Infuse.
In mid-November 2008, Medtronic disclosed that the Department of Justice, (DOJ) was investigating the off-label use of a Medtronic implant. The active ingredient in the Infuse Bone Graft is rhBMP, which is a protein that may be causing various potentially lethal side effects to patients within hours or days of surgery, including swelling of neck and throat tissue that can result in suffocation. Use of the Infuse Bone Graft or rhBMP in the cervical spine surgeries is clearly off-label.
The FDA has received 280 reports of side effects involving the Infuse and about three-quarters of those reports involved off-label use of the Infuse Bone Graft.
The government typically investigates claims of off-label use involving medical devices and pharmaceutical drugs because the government, through insurance programs like Medicare and Medicaid, purchases such health care products. Off-label use of the Infuse Bone Graft would likely not be covered by Medicare and any claims submitted for reimbursement to Medicaid or Medicare might require a representation that the device was used for its intended purpose and not for any off-label purpose. Because the Infuse Bone Graft is not approved for cervical spine surgery, use for that purpose would be considered off-label.
The letter also cites a report from last August linking Infuse to cancer.
Looks like it could be a long summer for Medtronic. We’ll keep you posted.
Medtronic says Infuse has been implanted into more than 500,000 patients and it is used by more than 2,300 surgeons. Its sales amount to several hundred million dollars a year.
Baucus and Grassley wrote in a statement:
“We are extremely troubled by press reports suggesting that doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic were aware that Infuse, a treatment commonly used in spinal surgery, may cause medical complications, but failed to report this in the medical literature. This issue is compounded by the fact that some clinical investigators have substantial financial ties to Medtronic.”
Infuse, also known as bone morphogenetic protein-2, is a powerful biological agent used in spinal fusion surgery. The product stimulates bone growth and eliminates the need to harvest a small amount of a patient’s own bone to create a fusion between two vertebrae. As a result, it is highly popular with spine surgeons.
“These reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling. Information is one of the most important tools patients and doctors have when making medical decisions. Patients have a right to know the risks associated with their treatments and medical device companies have a duty to disclose this information. We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits.”
It has also been reported in a Medtronic-funded study published in 2004 that 75% of patients who got Infuse developed ectopic bone, outside the targeted fusion area. The authors of the study, several of whom had financial ties to Medtronic, concluded that “although not desirable” the bone formation in the spinal canal did not appear to have an ill effect on patients.