Infuse Lawyers Orlando and Winter Park

Infuse Lawyers Orlando and Winter Park

Posted By The Maher Law Firm || 26-Jun-2013

Medtronic

Infuse is less invasive than a “traditional” bone graft system. It is a two part system consisting of a protein found in the body and a natural carrier that is a sponge manufactured from a cow type 1 collagen. Infuse acts as the scaffold in a surgical bone grafting procedure. It is manufactured by Medtronic Inc.

Recently two independent reviews found that Infuse works no better than a graft and can carry adverse effects such as a risk of cancer, male sterility and infections. “There is a tremendous amount of uncertainty about the benefit it provides and how safe it is.” Harlan Krumholz, Yale University professor.

Chris O’Connell, president of Medtronic’s Restorative Therapies Group said, the risk of cancer is low and the risk from Infuse is inconclusive. “This is a really important product and it’s one that deserves a lot of attention from the standpoint of clinical research.”

Yale review analyzed findings from two separate research groups. They were given detailed data from 17 spinal studies using Infuse on more than 2,000 patients. “We couldn’t find a clear advantage in terms of benefits, and when you take into account there could be potential risks that should be more carefully evaluated, it tips the scales toward not using it.” said senior author Mark Helfand, an internal medicine specialist at OHSU.

University of York reviews found Infuse fusion rates to be better after two years, with pain early on and less pain later. It also found that cancer may be more common with the use of Infuse.

Medtronic is accused of manipulating information about Infuse by helping to write and edit medical journal articles attributed to outside physicians, which, downplayed the risks of Infuse, according to a report by Senate investigators. The Senate Finance Committee said that Medtronic did not disclose its role in shaping 13 key studies of Infuse, which helped turn the bone graft into an $800 million a year product.

Reuters News Services, “Medtronic paid about $210 million in royalties and consulting fees to the author of company-sponsored studies between November 1996 and December 2010.”

Medtronic disagrees with the findings in the report saying “Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events.” The company’s spinal treatments fell 1.1% to %52.92. However, the shares have gained 39% in past months.

If you believe that you or a loved one has suffered injury or death due to a defective or dangerous pharmaceutical, you may have a right to compensation for your injuries. The Maher Law Firm would like to help. We invite you to contact our trial-tested dangerous drug attorneys today.

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