Parker Waichman LLP Asks: Why Is Medtronic’s Infuse Bone Graft Product Still Available if Clinical Studies Say It Is Lacking Benefits and Potentially Harmful?

July 2, 2013

Two independent clinical studies of Medtronic’s Infuse Bone Graft device revealed that the product offers no benefits and could potentially cause harm to those implanted with it. In view of these findings, Parker Waichman LLP asks: Why has the product not been pulled from the market?

New York, New York (PRWEB) July 02, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that Medtronic’s Infuse bone graft product should be pulled from the market immediately, in light of two independent clinical studies overseen by Yale University that offer strong evidence that the product does not work and could potentially cause cancer and other medical problems.

Published on June 18 in the medical journal Annals of Internal Medicine, the two studies* offer several key findings, namely that there is no difference between using Infuse and a traditional bone graft; that the initial Medtronic Infuse research was biased, and that there is a small, increased risk of developing cancer or, in men, retrograde ejaculation, a cause of male infertility.

(*http://annals.org/article.aspx?articleid=1696646; http://annals.org/article.aspx?articleid=1696645)

Dr. Harlan M. Krumholz, a Yale professor who oversaw the reviews, noted that while the findings of the two teams slightly varied, they still pointed toward the same results. “The general, overall picture is that they failed to find a big benefit” for Infuse, Dr. Krumholz told the New York Times in a June 17 article. “And they found there might be some harms.”

“If this medical device offers no key benefit, then why is it on the market?” said Gary Falkowitz, Managing Attorney from Parker Waichman LLP. “If there is even the slightest chance this product will cause someone to develop cancer or, if you’re a male, develop infertility, then why in the world would a patient choose this device as opposed to an option that is not only just as effective, but probably safer?”

Medtronic approached Yale University researchers after a June 2011 study published in The Spine Journal disclosed that Medtronic-paid researchers had failed to report serious potential complications from use of Infuse bone graft products in spinal surgery.

In addition, as noted in an Oct. 25, 2012, Bloomberg Businessweek report, the U.S. Senate Finance Committee found problems with most of the initial Medtronic-supported Infuse research used to promote the product. The article noted that doctors and researchers who authored at least 11 medical journal reports about Infuse were paid approximately $210 million in royalties and consulting fees. Senate investigators also charged that Medtronic deliberately manipulated studies to mitigate any adverse reactions to Infuse side effects, as well as to promote off-label use.

Parker Waichman LLP is currently offering free legal consultations to victims of Medtronic Infuse Bone Graft Injuries. If you or a loved one suffered a serious complication or injury after receiving Medtronic Infuse, please contact their office by visiting the firm's Medtronic Infuse injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).


Parker Waichman LLP

Gary Falkowitz, Managing Attorney

(800) LAW-INFO

(800) 529-4636


For the original version on PRWeb visit: http://www.prweb.com/releases/medtronic_infuse_remove/MM/prweb10896717.htm

Source: prweb

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