Product News and Recalls

Report: Bone growth device a ‘cautionary tale’

A joint report by MedPage Today and the Milwaukee Journal Sentinel takes a look at a bone growth agent called Infuse, made by Medtronic, which has caused a number of health problems in patients who received it.

According to the report: “The story of how the product … went from revolutionary advance to public health alert is a cautionary tale that is equal parts the art of medicine and the art of the deal.”

The report describes the Infuse product as a tapered, metallic fusion cage containing BMP-2, a genetically engineered human protein on an absorbable sponge made of bovine collagen. Once implanted, the protein essentially turns whatever it touches into human bone.

“This was a good thing if it could be confined to the tiny space between vertebrae, but potentially calamitous if it leaked out,” the report says.

The U.S. Food and Drug Administration approved Infuse in 2002. Since then, Medtronic allegedly promoted it for “off-label” uses, or uses that fall outside the purview of its FDA approval. Physicians can legally prescribe medical products for unapproved uses, but manufacturers aren’t allowed to promote them that way.

Widespread lawsuits have alleged that patients who received the off-label procedures weren’t warned of the potential risks, and suffered side effects including chronic pain and uncontrolled bone growth in the spinal canal.

The Medtronic report said studies published since 2002 have confirmed widespread use for unapproved indications, and significant reports of adverse reactions. Concerns range from formation of bone in unwanted locations to Infuse’s potential for fueling the growth of cancer cells or sparking adverse immune system reactions.

One member of a panel of FDA advisers who met in January 2002 to consider whether to recommend approving the product raised a question about the research findings that Medtronic filed as part of its application.

According to the report, that panel member pointed out the fact that nine of the doctors who authored the research submitted to the FDA had a financial stake in the product. Their studies all had findings that were twice as good as studies from researchers who did not have a financial interest in the product.

At the time, according to the report, the FDA glossed over those concerns.

Lopez McHugh is currently investigating Medtronic Infuse lawsuits, based on the above allegations and other information indicating problems with this medical device. If you have ongoing pain after use of a Medtronic Infuse procedure, contact a medical device attorney at Lopez McHugh to find out if you have a claim.

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