Researchers Withheld Medtronic INFUSE Bone Graft Problems
A new report shows that surgeons who received millions of dollars from Medtronic did not report serious side effects and complications experienced by patients receiving the Medtronic Infuse bone graft product.
Published in The Spine Journal, the report found that roughly 10% to 50% of patients who participated in clinical trials experienced Medtronic Infuse problems, such as cancer, pain, infection, and sterility. Notably, these problems did not appear in a number of studies published by researchers who had financial ties to the manufacturer.
The report shows that 15 of the researchers who took part in the noted studies received $62 million from Medtronic over a 10-year period. Though the publications are meant to be peer-reviewed, many of them failed to catch seemingly obvious discrepancies, states the study.
Just days before these findings were released two U.S. senators wrote a letter to Medtronic seeking answers in light of these allegations.
Chair of the Senate Finance Committee, Montana Democrat Senator Max Baucus, and the committee’s ranking member, Senator Charles Grassley (Rep) of Iowa, have asked Medtronic to turn over all communications with medical journals, clinical investigators, physician consultants, and the FDA and its advisory boards that relate to Infuse complications. The senators are also looking for detailed accounts of money remitted to researchers involved with Infuse clinical trials, along with other documents relating to this matter.
Medtronic Infuse is a bioengineered bone morphogenic protein (BMP) that fills gaps between vertebrae by replacing spinal discs and encouraging bone growth. Approved by the FDA in 2002, Medtronic Infuse generated roughly $900 million in sales last year.
It has long been suspected by a number of health care professionals that there is a link between Infuse and male sterility; however researchers sponsored by Medtronic in 2009 found no such link. Their findings came into question by other medical researchers when it was disclosed that Medtronic paid these professionals millions in consulting fees. The study, which concluded that male sterility after anterior lumbar fusion surgeries was the fault of the doctors, did not identify which patients were given Infuse. Later, study researchers disclosed that five of the six men treated were given Infuse.
Medtronic Infuse already has a warning about male sterility on its label. This product has also been linked to serious and potentially fatal complications caused by airway compression when it is used in an “off-label” capacity in the cervical spine.
After experiencing problems with Medtronic Infuse after cervical spine surgery, a number of patients have needed respiratory support tracheotomies, feeding tubes, anti-inflammatory drugs, and additional surgery. In many cases, this was caused by swelling of the neck. These problems led to an FDA warning in July 2008, highlighting at least 38 reports of cervical spine fusion problems with Infuse.
Contact a Medical Device Attorney
If you received Medtronic Infuse during neck surgery and have subsequently experienced negative side effects or complications, you may be entitled to compensation in a defective medical device lawsuit. Contact a medical product liability lawyer today for a free legal consultation.