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About Infuse Bone Grafts

Medtronic Infuse bone grafts have been among the most common used in spinal fusion surgeries for the past decade. The Medtronic name was once synonymous with bone grafts, with its Infuse products used in 44 % of all U.S. bone graft procedures in 2011 ( an estimated value worth about $900 million).

Bone grafts are bone replacements or substitutes and may be derived from an animal or human donor or from synthetic materials. Infuse bone grafts are synthetic. They were designed to be used in spinal fusion surgery and tibial fractures and have been approved for use in sinus augmentation and alveolar ridge augmentation surgeries as well.

Additionally, Infuse bone grafts account for 90 percent of the U.S. bone morphogenetic protein (BMP) market. This is a huge market covering allograft bone, cell-based matrices, bone substitutes, and demineralized bone products.

Infuse bone grafts tied to severe side effects

After a substantial number of complaints were received about significant side effects suffered by Infuse patients, there were some private inquiries into the marketing of Infuse. In these inquires, Medtronic was accused of downplaying the risks of Infuse by funding scientific articles that did not mention the possibility of certain complications.

One particular study, published in The Spine Journal by Dr. Eugene J Carragee, showed Medtronic had paid millions of dollars to many of the article and study publishers for “consulting fees.” Once this editorial ran, the U.S. Senate opened an inquiry into Medtronic where Sen. Max Baucus (D-Montana) commented, “Medtronic’s actions violate the trust patients have in their medical care.”

This type of unethical medical reporting forms the basis of several current lawsuits against Medtronic, alleging deceptive marketing practices and willful neglect of duty that led to serious injuries in patients using Infuse bone grafts.

Reported Infuse bone graft side effects include:

  • Increased cancer risk
  • Male sterility
  • Increased infection rate
  • Urinary problems
  • Bone and nerve injuries
  • Retrograde ejaculation
  • Inflammation
  • Bone loss and tissue degeneration
  • Implant displacement
  • Ectopic bone formation
  • Persistent pain
  • Death

Traditional bone grafts

Traditional bone grafts are used to repair bone damage or to replace or augment a failing bone structure. Over 80 percent of all bone graft surgeries in the United States are done to support the spine during vertebrae fusion surgery. The support bone comes from one of two categories, either a natural source harvested directly from the patient or from a donor or bone substitute.

Natural bone grafts include autogeneous bone grafts, allogenic bone grafts and xenogenic bone grafts. Autogeneous bone is harvested directly from the tibia, hip, jaw, chin or skull of the patient and nearly eliminates the chance of rejection in the graft area. Harvesting bone from the patient can have complications including pelvic fractures, bruising, pain and secondary infection – all of which will heal slower due to the multiple surgical areas necessary for the procedure.

Allogenic grafts are harvested from other humans (often cadavers). These bones can carry disease or infection from the donor to the new host, or can cause a reaction in the host’s immune system. This is also true for Xenogenic graft material, which harvested from cows due to their compatibility with human bone. In addition, it is very hard to control the quality of bone material from donated sources.

Demand for Medtronic Infuse grafts increases

The numerous issues with natural bone graft material led to a demand for synthetic bone grafts. There are three major kinds of synthetics used in bone graft procedures, although the latest – BMP – was the industry favorite until 2012.

Ceramic bone grafts used to be the industry standard because they created a mesh-like surface for natural bone to grow into. This scaffolding did not provide immediate relief to the patient, but allowed for a full bone fusion through natural patient bone growth.

Demineralized bone matrix (DBM) is a substitute that is created by processing allograft bone. It takes collagen, proteins and growth factors from the bone and applies them directly to the site where they can absorb minerals and grow into place. A common practice of combining ceramic structure with collagen in a composite graft has become much more popular in recent years.

But, by far, the biggest player in the bone graft industry is bone morphogenetic proteins (BMP). These are synthetic versions of naturally occurring proteins that create a strong, immediate bond to the graft area. Medtronic’s product is a type of BMP bone graft.

Infuse is a blend of rhBMP-2 and cow collagen that is injected into the graft area to relieve pain and promote structural bone growth. This synthetic combination is easy to monitor and control so graft quality is not an issue.

Medtronic Infuse litigation

There is little argument that Infuse does promote bone graft growth. The problem is that it also has risks of complications that were not divulged by Medtronic to doctors or patients. With the popularity of Infuse bone grafts since their approval in 2002, there could be thousands of Americans suffering from symptoms directly related to their bone graft surgery.

When Dr. Carragee published his report in 2011, it opened the doors for concerned surgeons and patients to look deeper into the possible side effects of Infuse graft products. It also led to the filing of dozens of Infuse lawsuits against Medtronic alleging major complications as well as unethical practices and deceptive marketing on the part of the defendant.

A recent example comes from Abingdon, Virginia, where resident Sandra F. Danna has initiated legal proceedings against Medtronic in connection with the serious harm she allegedly sustained following surgical implantation of Infuse bone growth protein. Danna’s court filing states that she remains in constant pain, is unable to perform routine household and other tasks, has had to relocate to Virginia in order to live nearer her adult children and is unlikely to be able to return to work.