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Study Details Medtronic Infuse BMP Problems, Finds Link to Tumor Growth

A study published this month by Duke University raises new concerns about Medtronic’s Infuse bone graft product. Published in the medical journal Neurosurgery, the study examines the potential link between the use of a bioengineered protein called BMP, which is contained in the Infuse bone graft, and cancer. Researchers found that side effects of Medtronic Infuse surgery may include a significant increase in the risk of tumor growth, but that the tumors are typically benign.

Medtronic Infuse BMP problems

The Duke research examined records of more than 4,600 patients who underwent spinal surgery using Medtronic’s Infuse bone growth product, which utilizes recombinant human bone morphogenetic protein 2, or BMP. The data was compared to that of spinal fusion surgery patients whose procedures utilized methods other than the Infuse device— for instance, harvesting bone from a patient’s hip.

The study found that patients who underwent procedures using Infuse had a statistically significant 31% higher chance of developing non-cancerous tumors, including benign growths in the central nervous system and brain. The researchers also discovered that the BMP Infuse patients had an increased risk of developing malignant cancer compared with the patients who received non-BMP treatments – 9.4% to 8.4%, respectively – but the difference noted did not rise to the level of being statistically significant.

The study is “the largest to date examining the association between BMP use and cancer,” according to the Duke University press release.

Side effects of Medtronic Infuse surgery

Medtronic’s Infuse bone growth product has faced its share of controversies since its 2002 approval by the Food and Drug Administration. Numerous lawsuits have been filed in state and federal courts around the U.S. seeking compensation for injuries allegedly caused by complications from Infuse grafts, including patient paralysis, nerve and airway compression, cancer, the inability to urinate, male sterility and retrograde ejaculations, all allegedly caused by uncontrolled bone growth on or near the spine.

Infuse bone graft lawsuits have claimed that Medtronic illegally marketed and encouraged off-label use of the bone growth products – thereby increasing complications for patients – by making tens of millions of dollars in consulting and royalty payments to doctors and researchers who omitted the risks of Infuse surgery from their journal articles. In some cases, Medtronic staff even authored or edited portions of the purportedly independent studies that promoted the off-label procedures linked to Infuse, according to a congressional investigation.

“Reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling. We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits,” said Senator Max Baucus, chairman of the Senate Finance Committee.

BMP bone growth products

These types of bone growth devices work by delivering the BMPs directly to the exact site of a fracture through the use of a bone implant that gradually releases the proteins in order to stimulate bone growth. The implant enables the growth promotion by allowing the localized and prolonged depositing of the BMPs over a period of weeks.

While these implants have been approved for specific lumbar spinal fusion applications, many of the Medtronic Infuse BMP problems and related lawsuits stem from off-label usage, which is allowed once a product has been approved. In fact, reports indicate nearly  85% of all BMP usage is for off-label procedures. The rate of complications – including uncontrolled bone growth around the spine, respiratory complications, and now, according to the new study, tumor growth – appear to increase when the BMPs are utilized in off-label manners not approved by the FDA.

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