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INFUSE Bone Graft Problems

INFUSE bone graft problems

Damaged or diseased bones are often held together by a synthetic, concentrated protein called a “bone graft.” In 2002, the U.S. Food and Drug Administration (FDA) approved the Medtronic INFUSE Bone Graft made from synthetic protein mixed with cow collagen for use in spinal fusion procedures. In addition to spinal fusions, INFUSE bone grafts are used in everything from tibial fracture repair to sinus cavity dental procedures. It is estimated that this type of bone graft is used in approximately 100,000 spinal fusions each year, with sales topping $900 million. Medtronic quickly became the leading industry supplier of bone grafts, accounting for 44 percent of the $1.9 billion market. Despite the impressive statistics, there have been a number of reported INFUSE bone graft problems over the years that left patients with debilitating injuries and complications.

Who needs Medtronic INFUSE bone grafts?

About 84 percent of bone grafts are used in back surgery to relieve arthritis or degenerative disease in the 432,000 spinal fusion procedures done in the United States each year. Surgeons fuse together damaged vertebrae to form one solid bone mass and alleviate chronic nerve irritation in the spine. However, the surgery is notoriously risky. Doctors typically remove bone from another part of the patient’s body for the procedure. Patients complain of pain at the harvest site and suffer additional risks of infection, pelvic fracture and disease. Medtronic promoted its INFUSE bone grafts as a safer alternative to the traditional method.

Common INFUSE bone graft complications

At the bare minimum, patients reported adverse INFUSE bone graft side effects such as:

  • Inflammation
  • Infections
  • Urinary problems
  • Back and leg pain
  • Male sterility
  • Radiculitis (shooting pain spreading through spinal nerves)
  • Retrograde ejaculation (where semen travels into the bladder)

More severe complications with INFUSE bone grafts

However, there were also reports of very severe and life-threatening complications, including:

  • Implant displacement
  • Cancer
  • Ectopic bone formation
  • Difficulty swallowing, speaking or breathing
  • Degeneration of bone tissue
  • Death

INFUSE bone graft problems prompt federal investigations

Due to the pervasiveness of the INFUSE bone graft problems, investigators began looking into the root cause of the adverse reactions. The U.S. Department of Justice accused Medtronic of paying illegal kickbacks to doctors who used INFUSE bone grafts between 1998 and 2003. Medtronic reportedly used “lavish retreats to desirable locations” to win over medical professionals. The company paid $40 million in a civil suit against them to settle these charges.

The FDA issued a Public Health Notification warning health care providers about “life-threatening complications” arising from off-label use of INFUSE bone grafts on July 1, 2008. According to the letter, the FDA received at least 38 reports of complications during a four-year period. “These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking,” the report stated. Furthermore, they indicate that “treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomy and most commonly second surgeries to drain the surgical site.”

In 2011, Dr. Eugene J. Carragee published a scathing editorial that revealed Medtronic’s failure to disclose any adverse INFUSE bone graft side effects following their own sponsored studies. The study also revealed that researchers had been paid anywhere from $1 million to $23 million a year in royalties and consulting fees for their implicit cooperation in the studies. The U.S. Senate launched their own investigation in June 2011. In 2012, Medtronic agreed to pay a settlement of $85 million to resolve claims that 85.2 percent of their profits came from “off-label uses.”

Studies reveal high rate of INFUSE bone graft complications

Early clinical studies reviewed by the FDA showed that the most common INFUSE  bone graft problems included inflammation of nearby tissue and bone. This, in turn, caused urinary problems and stimulated cancer in many cases. Dr. Carragee found that Medtronic’s product had a 43 percent higher complication rate than products made without bone morphagenetic protein. Compared to traditional surgery, which removed bone from the patient’s hip,  the rate of complications was the same or greater, despite being promoted as a “better solution.” The second most common complication was leg and back pains, reported in 15 to 20 percent of all INFUSE bone grafts. By April 2011, the FDA had received hundreds of reports of adverse infuse bone graft side effects.

Injured patients file lawsuits against Medtronic

It is estimated that several thousand people have been injured by Medtronic’s INFUSE bone grafts since 2002. So far, at least 100 victims have sought damages by filing an INFUSE bone graft lawsuit against the company.  One plaintiff, April Cabana, filed suit in July 2011 for injuries she suffered as a result of her bone graft procedure. After the initial surgery was unsuccessful, she underwent two subsequent operations to treat her lower back pain. At the young age of 34, she found herself in such debilitating pain that she was unable to work and was forced to go on disability.

A similar claim filed in October 2011 alleged that a woman underwent a spinal implantation procedure in February 2009, which caused her to suffer a burning pain down her right leg that later spread to her left side and rendered the plaintiff unable to work. The lawsuits accuse the company of failure to warn, negligence for faulty design, failure to recall the product, fraud for misrepresenting the benefits of the product, designing and distributing defective medical devices, as well as breach of express and implied warranty.