cialis online

Senators Seek Info On Medtronic Infuse

AddThis Social Bookmark Button

In the midst of probes, shareholder lawsuits, and broad criticism concerning its Infuse bone growth product, Medtronic is making headlines again. This time, three senators are asking for information on Medtronic’s Infuse product.

Senators Charles Grassley (Republican-Iowa), Herb Kohl (Democrat-Wisconsin), and Richard Blumenthal (Democrat-Connecticut) asked, in a letter described by The Star Tribune as having an “investigational tone,” for very specific information on how Medtronic monitors its products once they are released and for information on Infuse.

The six-page Medtronic letter is one of five similar letters sent to other medical device makers whose products have failed after being released to the market, said The Star Tribune. The three senators also introduced legislation to mandate device makers conduct clinical studies of their products after release to the market for all products released via the controversial fast-tracked 510(k) approval process that allows device makers to skip intense pre-market testing that involves, for instance, human trials.

The senators discussed potential conflicts of interests in the letter to Medtronic, specifically concerning Infuse. “A researcher at Stanford University School of Medicine found a higher risk of cancer associated with Infuse, and there have been allegations that researchers who received funds from Medtronic, sometimes millions of dollars, did not report negative findings from clinical trials,” the letter states, wrote The Star Tribune.

Meanwhile, NewsInferno just wrote that a shareholder lawsuit alleging that Medtronic illegally promoted Infuse off-label has been granted class action status. The lawsuit was filed by a number of institutional investors on behalf of Medtronic shareholders who purchased or acquired the stock during November 2006 – November 2008 and who suffered financial losses.

This summer, said NewsInferno, Medtronic was accused of downplaying Infuse’s more serous side effects and, recently, a renowned researcher warned that Infuse may be linked with increased cancer risks. Also, said NewsInferno, in Medtronic’s recent 10-Q filing with the U.S. Securities and Exchange Commission (SEC), Medtronic disclosed that California’s Attorney General’s Office issued a subpoena to Medtronic in October as part of its Infuse investigation. Infuse is also the focus of a U.S. Justice Department probe spearheaded by the U.S. Senate Finance Committee, said NewsInferno

Infuse bone graft is made from the genetically engineered rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), a material that stimulates bone growth and which was approved by the U.S. Food and Drug Administration (FDA) in 2002 for use in one type of spine surgery: lumbar fusion, NewsInferno explained. Subsequently, Infuse was approved for use in two types of dental surgeries; however many patients have undergone spinal fusion surgeries and received Infuse bone graft implantation in which nonapproved methods were utilized or in which other spinal parts, for which Infuse was not approved, were involved. NewsInferno pointed out that in July 2008, the FDA warned that Infuse and other, similar bone growth products, were know to cause significant problems when used off-label in spinal procedures.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com