Medtronic Infuse Linked To Neck Problems In Data Kept From FDA For Years

According to a new investigative report, Medtronic may have hidden away dozens of reports involving problems with Infuse bone growth implants for years, including reports that the the product caused severe swelling and nerve damage in the neck.

In 2016, the Star Tribune reported that the manufacturer withheld from federal regulators more than 1,000 injury reports associated with Medtronic Infuse, which is a bio-engineered bone graft product promoted as an alternative to spinal fusion procedures.

Following a release of data through a Freedom of Information Act request, the newspaper published an updated report last week, which highlights details about 100 of these post-surgical neck problems linked to Medtronic Infuse, including some that involved life-threatening injuries.

Medtronic Infuse is a recombinant human bone morphogenetic protein (rhBMP-2), which is implanted to encourage bone growth and fuse gaps between the vertebrea. The product is designed to avoid the need for bone to be 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.

The recently disclosed data involves a previously “lost” study of postsurgical complications linked to the Medtronic Infuse product, which involved 3,600 subjects. The research was shut down in the spring of 2008, but Medtronic sat on the data for at least five years, without disclosing it to federal regulators as required by law.

An analysis revealed numerous cases of nerve damage, excessive bone growth and breathing problems. Out of data on 1,039 surgical complications, most of which involved the lumbar spine, more than 100 involved procedures in the neck, which is an “off-label” unapproved use. Medtronic cannot promote that Infuse be used for neck procedures, but doctors are legally able to use medical devices and drugs for whatever purpose they deem appropriate.

The manufacturer has faced hundreds of Medtronic Infuse lawsuits in recent years, which alleged that the company 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.

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.