The Senate Finance Committee has launched an investigation into the physicians who consulted with Medtronic on its Infuse after a recent study published in The Spine Journal showed a stronger correlation between the product and male infertility than was originally reported, according to a Wall Street Journal report.
The investigators are examining the company-sponsored clinical trials showing several complications, which went unreported in the research papers describing the trials. A study slated for publication next week examines the data from the clinical trials and the reports to the FDA, which may have failed to disclose potentially fatal complications, according to the report.
Medtronic maintains that the company provided data about the adverse events to the Food and Drug Administration, which approved the product in 2002 only for fusions in the lower spine using the anterior approach. In 2008, the FDA issued a safety alert concerning the off-label use of the product for cervical fusions.
Spine surgeon authors of these papers received millions of dollars from Medtronic in consulting fees or royalty payments, according to the report.
Read the report on the investigation of Medtronic's Infuse.
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The investigators are examining the company-sponsored clinical trials showing several complications, which went unreported in the research papers describing the trials. A study slated for publication next week examines the data from the clinical trials and the reports to the FDA, which may have failed to disclose potentially fatal complications, according to the report.
Medtronic maintains that the company provided data about the adverse events to the Food and Drug Administration, which approved the product in 2002 only for fusions in the lower spine using the anterior approach. In 2008, the FDA issued a safety alert concerning the off-label use of the product for cervical fusions.
Spine surgeon authors of these papers received millions of dollars from Medtronic in consulting fees or royalty payments, according to the report.
Read the report on the investigation of Medtronic's Infuse.
Related Articles on FDA Investigations:
FDA Sends Warning Letter to Anulex for Inappropriate Testing of Spinal Product
Federal Government Launches Investigation Into Adult Scoliosis Treatment
Medtronic Receives Subpoena Related to Marketing and Reimbursement Support of Neurostimulator