Medtronic Bone Drug Linked to Higher Risk of Cancer

According to information released at a conference of spinal surgeons this week, a popular bone growth product manufactured by Medtronic may increase the risk of cancer in patients, if used in high doses.

According to the New York Times, Medtronic provided the Food and Drug Administration data seeking approval to market a high-strength formulation of its Infuse bone growth product.  However, the data shows that the higher dose combination could increase cancer risks.  Based on this information, the Food and Drug Administration has rejected the high-growth formulation, which is called Amplify.

According to data that was released at the conference, there were a higher number of cancers in persons that were given the Amplify bone growth product, compared to another group of persons that was given a bone graft.  Both Amplify and Infuse have the same base ingredient, a bioengineered bone growth protein called rhBMP-2.

The increased cancer risks come from using Amplify, which is a higher-dose version of Infuse.  However, what really worries defective product attorneys is the fact that many doctors frequently use Infuse at higher-than-recommended dosage levels.  The dosage levels in Infuse, in some cases, can touch those found in Amplify.

The researchers are even more concerned about the possible risks of cancer in persons who received the higher-than-recommended doses of Infuse, and are already at a high risk of cancer.  These people include those who smoke, or suffer from any other health factors that increase their risk of cancer.  According to the findings presented at the conference, morphogenetic proteins are linked to a 2.5 times greater risk of developing cancer about one year after taking the product.  These persons also have a five times greater risk of developing cancer about three years after taking the product.

This is the first time that Infuse has been linked to health problems.  In June, the Spine Journal released a series of reports on complications involving Infuse use, including infections, bone dissolution, male sterility and leg and back pain.  Medtronic says that it is currently sponsoring research to study the safety of the Infuse bone growth product.  The results of the study will come out sometime in 2012.

What personal injury attorneys are really concerned is the widespread off-label use of Infuse.  Infuse has been approved by the Food and Drug Administration for use as part of dental procedures and in spinal fusion surgery.  However, doctors have been using it for a variety of other purposes as well, which are not approved by the Food and Drug Administration.

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