Navigation Links
Yale Releases the Findings of the Medtronic-Commissioned Infuse Bone Graft Study; Parker Waichman LLP Comments

New York, New York (PRWEB) June 18, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that the results of Yale University’s independent review of Medtronic’s Infuse bone graft products are now available. Published this week in Annals of Internal Medicine, a medical journal, the two studies serve up two key findings: There is “little to no difference in effectiveness” when comparing Infuse and the traditional bone graft; and there is “substantial evidence” that the initial Medtronic Infuse research was biased, according to a June 18 report in the (Minneapolis) StarTribune.

Specifically, the early research underreported side effects and emphasized favorable results, noted a June 17 Reuters report.

As for the supposed “underreported side effects,” Infuse allegedly poses potential health risks for patients: a small, increased risk of cancer, according to one team, headed by scientists at Oregon Health and Science University, the New York Times reported on June 17. Infuse also may possibly be linked to retrograde ejaculation, a cause of male infertility that occurs when semen is redirected to the urinary bladder rather than ejaculated via the urethra, according to a June 17 report on the Milwaukee-Wisconsin Journal Sentinal’s website.

And while Medtronic’s product did fuse spinal vertebrae more quickly than a traditional bone graft, the speed factor “appeared to lack clinical relevance,” according to the other team, led by researchers from the University of York in England, as the New York Times article reported.

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

“The research released this week on Medtronic’s Infuse is revealing,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “There may be no real advantage to using Infuse, except for the speed factor. At the same time there is a possibility that Infuse may cause cancer or, if you’re a male, sterility.”

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 about $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.

The U.S. Food and Drug Administration (FDA) approved Infuse in 2002 for use in fusing damaged vertebrae in the lower spine; Infuse was not approved for use on the upper, or cervical, spine, where it is now widely used, according to Bloomberg Businessweek report. In fact, the report added, the FDA released a July 1, 2008 notification warning that the Infuse Bone Graft had been associated with serious complications – including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing and nerve damage – when used in cervical spinal fusions.

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 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

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. AGA releases first independently developed ABIM-approved Practice Improvement Module in GI
2. Markle releases new resources for health information sharing implementation
3. ASCO releases studies from upcoming annual meeting
4. Boys Town Releases 5 Signs of Heat Stroke in Kids
5. MTSS-mba Membership Benefits Administration Software for Private and Taft-Hartley Employee Benefit Funds Releases New Pension Modules
6. Muscular Development Store Releases the Optimum Performance Workout for High Intensity Training
7. Premier global health journal, The Lancet, releases series on universal health coverage
8. Institute for Population Health Improvement releases buyers guide for health information exchange
9. CSHL Press releases new book on the biology of drug addiction
10. Nathan Wells Releases Audiobook Detailing Battle with Undiagnosed Medical Condition
11. Probiotic Action Releases a Statement in Regards to a Recent Miami Herald Article on Minimizing Scars
Post Your Comments:
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer ... through a fitness app. The fitness app plans to fix the two major problems leading ... a one size fits all type program , They don’t eliminate all the ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... Canada (PRWEB) , ... June 25, 2016 , ... Conventional ... pursuit of success. In terms of the latter, setting the bar too high can ... risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... 2016 Story Highlights: ... within the health care industry is causing providers to ... , Deloitte offers a suite of solutions for health ... efficient cost optimization: labor resource analysis, revenue cycle optimization ... better outcomes and better economics ...
(Date:6/24/2016)... 2016   Bay Area Lyme Foundation , ... Center for Tick Borne Illness , Harvard Medical ... Hacking Medicine, University of California, Berkeley, and the ... five finalists of Lyme Innovation , the ... 100 scientists, clinicians, researchers, entrepreneurs, and investors from ...
(Date:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
Breaking Medicine Technology: