Under the law, manufacturers of drugs sold to consumers or medical devices used during surgical procedures are required to disclose any and all possible dangers or side effects associated with the product. They are also mandated to be truthful about whether the product actually does what it’s intended to do so. Companies that misrepresent a product’s effectiveness will face scrutiny, criminal or civil liability.
A case in point involves the Infuse spinal fusion product manufactured by Medtronic, a leading medical device maker.
The Infuse bone graft
The Infuse product, also referred to as bone morphogenetic protein-2, was manufactured by Medtronic, a leading medical device maker, and approved for use by the FDA in 2002. It helps fuse human vertebrae after the removal of a degenerated disc and aids in mitigating pain and reducing overall healing time.
Medtronic touted the product as the best brand on the market with minimal-to no risk and maximum benefit.
However, U.S. spinal experts weren’t so sure, particularly after reports surfaced that the product had allegedly increased pain due to excessive bone growth along the spinal cord. Some medical professionals indicated that Medtronic was misrepresenting the product and wasn’t truthful to consumers about its effectiveness.
Subsequently, Medtronic hired researchers from Yale University to investigate and conduct an independent study on the product and to help debunk the allegations. The results, published in a recent addition of the Journal Annals of Internal Medicine, were not exactly what Medtronic had hoped.
Independent research results
To help in the study, Yale researchers reached out to individuals from the University of York in England and the Oregon Health and Science University for assistance.
Researchers concluded that the product was essentially not any better and provided no added advantage than its older competitor. (This, not surprising since they also concluded that there was “substantial bias” in previous studies on Infuse. Overinflated information was found reported on the product by Medtronic sponsored publications.)
Researchers also concluded that the results of the findings showed that the use of Infuse posed an increased risk of cancer-information not previously disclosed by Medtronic after its FDA approval.
According to Journal’s Editor in Chief Dr. Eugene Carragee, the findings present a “take-home message.” He indicated that more oversight against potential biased findings is needed before the results of any medical study are used to allow the public to make decisions.
To date, the Infuse product has been used in more than 1 million cases worldwide.