Infuse Bone Graft/LT-Cage, a lumbar tapered fusion device manufactured by Medtronic Inc. (MDT), was discovered to be little better than a regular graft and may come with a range of associated health risks which include cancer.
Infuse is now widely established in the health care industry, however it was thought to be linked to adverse events such as male sterility, infections and even cancer. Before a full scale Medtronic infuse lawsuit was launched, a comissioned review of Medtronic’s Infuse took place in 2011.
Early studies regarding Infuse lead to the conclusion that the product was risk-free, however there have been reports of existing financial ties between the researchers and the innovator company. This leads to the question of integrity in the early data and may in fact have prompted the Medtronic infuse lawsuit.
The Krumholz’s Yale University Open Data Access project reviewed data and findings for Infuse, among other products, and published their findings publicly for other researchers.
Infuse vs Bone Grafts
Two research groups submitted their findings on the issue of Infuse being no better than bone grafts. One of the groups (Oregon review) found that the effects, success and risks of both Infuse and bone grafts were highly similar. For the second group (University of York) found that fusion rates with infuse were better after two years, perhaps with more early pain than later pain. The incidence of cancer was definitely present in a small number of people. However, the risk of developing cancer with Infuse use has still not been firmly established.
Medtronic Infuse and Risk of Cancer
As was mentioned, the rates of cancer from Infuse use were low. Medtronic is considering the occurrence of a small increased risk of cancer associated with Infuse as well as the likelihood of improper usage leading to an elevated cancer risk. For instance, the product is not approved for use at the top of the spine since doing so might lead to complications.
Widespread Use of Medtronic Infuse
In earlier days, the use of Infuse was used everywhere. Physicians believed it carried very little adverse effects and recommended it for a wide variety of conditions. However, at present, doctors seem to have established its’ appropriate use thus its’ administration is significantly more limited.
Although there are a few companies like Nuvasive Inc and Johnson & Johnson who have developed similar products, these have yet to be established in the medical field like Infuse has.