Infuse and Amplify Complications

Aug 8th, 2011

If you, or someone you know, was given Infuse or Amplify during spine fusion surgery, you need to know that the Shelton Law Group is representing individuals who have been diagnosed with male sterility, cancer, unwanted bone growth, or nerve damage. Infuse, and its sister product Amplify, are bone-growth proteins made by Medtronic, a Minneapolis-based medical device maker.

Recently, a special issue of the medical journal, The Spine Journal, issued a report criticizing a large number of U.S. doctors who under-reported or failed to report these dangerous complications. The report also criticized numerous doctors who wrote 13 papers between 2000 and 2010, but did not mention, or downplayed, the dangerous side effects of Infuse and Amplify.

Medtronic sponsored these 13 papers, and paid the doctors millions of dollars in royalties and fees during that 10 year period to promote the protein. The papers said that Infuse and Amplify were at least as safe as bone grafts, but The Spine Journal said the risk of these negative side effects was anywhere from 10 to 50 times higher than originally estimated.

This means that many patients were given Infuse or Amplify without knowing the full risks, and were placed at needless risk. However, bone grafts — taken from the patient's own hip — were said to be "at least as safe," but now are understood to have been 10 to 50 times safer.

The alleged omissions have been so troubling to lawmakers that the Senate Finance Committee has begun an investigation. Senator Max Baucus (D-Montana), chair of the committee, calls the possibility that these doctors may have hidden these complications "deeply troubling."

Industry analysts predict Medtronic will make $859 million in the next sales quarter, which is a 2% decline from 2010 sales.

We are asking anyone who was given Infuse or Amplify during spine fusion surgery to contact our hotline at 877-814-5526, or to visit our Medical Malpractice page to schedule a FREE case assessment.