Medtronic Infuse Problems Hidden From Regulators, Report Claims

A new report suggests that Medtronic failed to adequately inform federal regulators about more than 1,000 adverse event reports linked to its Infuse bone growth product for years, including at least four patient deaths. 

Medtronic Infuse is a bio-engineered bone graft product, which has been promoted as an alternative spinal fusion procedure. The recombinant human bone morphogenetic protein (rhBMP-2) is implanted to encourage bone growth and fuse gaps between the vertebrea, providing an alternative to traditional spinal fusions, where bone is harvested from another area of the body or used from a cadaver.

In recent years, a number of serious concerns about problems with Medtronic Infuse have been linked to the product, including instances of bone overgrowth, inflammatory reactions, nerve damage, respiratory compression and other complications, including death.

According to a special report published this week by the Minnesota Star Tribune, Medtronic may have known about the risk of Infuse complications for years, and failed to properly report the issues to the FDA.

The Star Tribune indicates that the medical device manufacturer shut down a study involving 3,600 individuals in the spring of 2008, but failed to inform the FDA about complications experienced within the 30-day time period required by law.

Since the publication of this report, Medtronic has challenged many of the findings in a press release issued the same day, indicating that the information had been unfairly presented.

The manufacturer has faced hundreds of Medtronic Infuse lawsuits in recent years, which alleged that the manufacturer sold an unreasonably dangerous and defective product, failing to adequately warn consumers and the medical community about the risks associated with receiving the bone growth product.

The FDA only approved Infuse rhBMP-2 for limited use during spinal fusion procedures where the lumbar spine is approached through the front and the product is applied to an absorbable collagen sponge that is placed within an “LT-Cage” that is implanted to encourage bone growth and fuse the gaps between the vertebrae. However, the product has been widely used off-label during other types of spinal surgery, and many users have reported suffering catastrophic complications due to excessive bone growth around the spine.

Medtronic Infuse has been used on more than 1 million patients, according to the manufacturer. The study that is the focus of the Star Tribune article occurred between 2002 and 2006. However, it took the company five years to inform the FDA about the earlier complications reported by doctors during the retrospective chart review (RCR).

“Medtronic has acknowledged that at the time the RCR was discontinued back in 2008, it was not properly archived and the information collected was not fully assessed for reportability to the FDA,” the company admitted in its press release. “We have taken a number of steps to update our clinical policies and our training to enhance our reporting practices.”

The company claims the article falsely suggests the company was trying to conceal the information. However, the company has a history as a “bad actor” in how it conducts clinical trials and influences medical studies.

In 2012, a congressional investigation determined that Medtronic paid $210 million to study authors that failed to include data on complications linked to its Infuse bone growth product in their reports. Those authors not only failed to disclose links to Medtronic, but the investigation also determined that Medtronic employees secretly edited and sometimes wrote parts of the studies before they were published, which encouraged the off-label use of Infuse.