Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking layoffs.

Medtronic also saw the performance of its cardiac rhythm management division continue to slide, with sales of implantable cardioverter defibrillators down about 2% in the first quarter. Still, that’s an improvement over the same quarter last year which saw a 14% decline MassDevice.com said.

Together the cardiac rhythm and spinal divisions made up a 10% decline for the year ended April 27, MassDevice.com said.

Yesterday, Medtronic announced it was planning to layoff about a 1,000 employees globally. According to MassDevice, around 200 will come from the cardiac rhythm business, but the company isn’t saying what other divisions will be impacted.

Medtronic Infuse Controversy
Over the past year, Medtronic has taken heat over the safety of its Infuse Bone Graft, a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) that is approved for use in a certain type of spinal surgery. Last summer, The Spine Journal raised disturbing questions about the way potential Infuse side effects, including cancer, were reported in clinical trials for the product. According to an article in the journal, 13 Medtronic-sponsored clinical trials downplayed serious Infuse complications, including:

• Ectopic or uncontrolled bone growth at or near the site of the surgery
• Ongoing or chronic radiating pain in the legs or arms
• Male sterility, retrograde ejaculation, or other uro-genital injuries
• Nerve injuries causing severe and chronic pain
• Cancer

A study released last November also linked high doses of rhBMP2 to an increased risk of cancer, including breast, prostate and pancreatic cancer.

After the Spine Journal published its expose, Medtronic took the unusual step of commissioning researchers at Yale University to review Infuse clinical trials. Results from that review are expected later this year.

Medtronic Infuse Lawsuits
Medtronic has also been named in personal injury lawsuits alleging Infuse caused serious side effects when used in off-label procedures. The U.S. Food & Drug Administration (FDA) has only approved Infuse graft for use in single-level anterior lumbar fusion. However, it is known that the majority of procedures that utilize Infuse are off-label . While doctors can use an FDA-approved product in anyway they see fit, manufacturers are legally barred from promoting those uses. Medtronic Infuse lawsuits allege that the company illegally promoted unapproved uses of Infuse.

In 2008, the FDA warned that Infuse and similar products had caused serious and potentially life-threatening problems when they were used off-label in cervical spine (neck) surgeries.