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INFUSE Bone Graft Problems

The use of bone grafts is a critical step in many different types of surgeries. Bone grafts are implanted by the surgeon to replace damaged, diseased, or lost bone mass, and to facilitate the healing of the existing bone structure. Although every procedure has risks of complications, some medical professionals and patients have noted that INFUSE bone grafts, manufactured by Medtronic, are especially prone to serious complications, ranging from infections to life-threatening cancer.

An overview of bone grafts

There are several different types of bone grafts. An autograft is a commonly used type of bone graft in which the surgeon harvests bone from one part of the body, such as the pelvic bone, and implants it into another body part, such as the spine. While autografts taken from the pelvic bone have a longstanding track record of success, there are certain downsides. An autograft raises the risk of fracture in the harvested area of bone, since there may be insufficient bone mass from which to harvest a graft, and patients often report significant, long-term pain.

Another type of bone graft is an allograft, in which processed bone from a cadaver is used. While this minimizes certain complications, an allograft may not be the best choice in some cases because cadaver bone does not regrow new bone.

Medtronic introduced its INFUSE bone graft in 2002 for the purpose of providing an alternative to allografts and autografts. The INFUSE bone graft is made from synthetic material and it was proposed as a safer method of boosting bone structure.

There are two main components to the Infuse bone graft. A sponge is manufactured from bovine collagen to act as a carrier, or a framework for the new bone growth. Over time, the bovine collagen is absorbed into the body and is replaced by the new bone growth. It also contains a protein, rhBMP-2, or recombinant human bone morphogenetic protein-2. This genetically engineered protein is intended to control the healing and growth of bone. The bovine collagen releases the protein over time.

FDA warning letter about off-label use

The INFUSE bone graft was approved by the FDA for use in the U.S. in 2002. It quickly became a bestseller and has been used in more than half a million patients. In 2011, it resulted in sales of $800 million for Medtronic. It was approved for use in dental, oral, and spinal procedures. However, physicians began using the bone graft in off-label procedures on areas such as the cervical spine and neck. This off-label use has resulted in numerous reports of bone graft problems, some of which have required revision surgery.

In July 2008, the FDA issued an open warning letter to healthcare professionals that linked the bone graft to life-threatening side effects. The letter was prompted by the 38 reports of side effects following cervical spine surgeries the FDA had received inside of just four years.

Medtronic faces growing litigation

The growing public outcry over the severe side effects and the improper off-label use of Medtronic’s bone graft products have resulted in Infuse lawsuits filed against the manufacturer. Plaintiffs often note that they were unaware that the manner in which INFUSE grafts were used was considered an off-label use, and that they never would have consented to the surgery had they been properly informed of the risks.

In some cases, off-label use of INFUSE involved surgeries other than cervical spine procedures, such as lumbar spine surgeries.

INFUSE lawsuits filed due to bone graft complications

  • Dr. Cristina Ramirez sued Medtronic after undergoing a lumbar fusion procedure in March 2009. She experienced significant, ongoing pain, uncontrolled bone growth, and nerve impingement at the location of the INFUSE bone graft. Her lawsuit claims Medtronic failed to notify the FDA of the potential for severe complications when used in an off-label manner.
  • Jennifer English received the INFUSE bone graft in August 2007, yet was later diagnosed with ectopic bone growth and nerve compression, and required two revision surgeries. English noted that Medtronic appeared to be more interested in financial profits than in the well-being of patients. Her lawsuit contends Medtronic is liable for improper promotion and marketing, and fraudulent misrepresentation.

Potential for serious side effects

In the FDA’s warning letter, the agency noted that most reports of complications from cervical spine surgeries occurred within two to 14 days of the surgery. Airway complications frequently required medical assistance. These airway complications included the swelling of the throat and neck tissues, causing airway compression and compression of the back’s neurological structures.

Patients experienced difficulty swallowing, breathing, and speaking. They also experienced severe dysphagia. The FDA strongly urged healthcare practitioners to use an approved bone graft for cervical spine surgeries, rather than the INFUSE product.

Some of the common side effects of INFUSE include:

  • Infections
  • Pain and discomfort
  • Bleeding
  • Scar formation
  • Sexual dysfunction
  • Gastrointestinal, bowel, or bladder problems
  • Damage to nearby tissues
  • Bone fracture
  • Failure to fuse

Medtronic lists other serious (and sometimes life-threatening) INFUSE bone graft complications as including:

  • Allergic reaction to the product
  • Abnormal bone formation
  • Loosening, breaking, or migration of the material
  • Fetal development complications
  • Paralysis
  • Other neurological problems
  • Changes in spinal curvature
  • Spinal cord and nerve damage
  • Vascular problems
  • Cancer
  • Death

Infuse bone graft problems studied

Scientific studies have substantiated the serious complications associated with the INFUSE bone graft. One study was published in the Spine Journal. The lead author, Eugene Carragee, noted that 10 to 50 percent of all patients who received the INFUSE bone graft experienced serious complications, including bone degeneration, aggravated back and leg pain, infections, sexual dysfunction, and even cancer.

Carragee reviewed previous studies of INFUSE and found an alarming trend. He determined that despite the high rate of complications, these problems were not reported in previous research papers published between 2000 and 2010. Carragee determined that 13 of these clinical trials were funded by Medtronic.

The Senate Finance Committee began investigating these claims of data concealment. The Senate investigators found that Medtronic had paid $210 million to the study authors over a period of 15 years.

“Medtronic’s actions violate the trust patients have in their medical care,” noted Sen. Max Baucus of Montana.