Robert J. Boumis  |  April 17, 2014

Category: Legal News

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Infuse bone graftA recent study suggests that Medtronic Inc.’s Infuse Bone Graft works no better than older spine grafts and carries an increased risk of cancer and other adverse side effects.

In a healthy spine, discs, a type of connective tissue, protects the bones of the spine and spinal cord from damage. However, certain diseases can weaken discs, endangering the spine and causing pain. One of the main medical tools against this condition is a type of surgery called spinal fusion, in which two or more adjacent vertebra are joined together, either by attaching them to rigid implants or encouraging the bone to grow together. One type of medical tool for spinal fusion, the Infuse Bone Graft System, has come under scrutiny due to safety concerns.

Infuse Bone Graft

The Infuse Bone Graft is a device used for spinal fusion. It consists of a metal support cage with a bioengineered tissue matrix. The bioengineered tissue matrix uses the patient’s own tissues to concoct a material that encourages vertebrae to grow together. The metal cage supports the bones, while adding additional stability and protection after the fusion.

Infuse Bone Graft Complications

It has been alleged that the Infuse Bone Graft may be linked with a number of serious side effects. This includes damage to the nerves of the spine, causing, pain, paralysis and numbness. Infuse Bone Graft complications have also been allegedly linked to infertility, cancer, and problems in the neck and throat.

Infuse Bone Graft Study

A recent study published in the Annals of Internal Medicine studied the risks and benefits of the Infuse Bone Graft. Infuse does have an advantage over some older types of bone grafts, which often require a separate surgery to harvest redundant bone from elsewhere in a patient’s body. However, the study found little difference in the ultimate outcomes of patients from both procedures. On top of this, traditional bone grafts have not been associated with many of the complications allegedly associated with the Infuse Bone Graft System.

“We couldn’t find a clear advantage in terms of benefits, and when you take into account there could be potential risks that should be more carefully evaluated, it tips the scales toward not using it,” said senior author Mark Helfand, an internal medicine specialist at Oregon Health & Sciences University in Portland.

Infuse Bone Graft Lawsuits

Lawsuits have been filed against Medtronic Inc., the maker of the Infuse Bone Graft. These Infuse bone graft lawsuits allege that the manufacturers were aware of the potential risks associated with the system, but continued to actively promote it. In fact, it has been alleged that the manufacturers actively promoted the device for off-label use. Off-label use means using a drug or medical device for other purposes than those approved by the FDA. Sometimes, new evidence may suggest that an existing device or drug can treat diseases and conditions beyond their original, FDA-approved purposes. Physicians are allowed to do this, since it takes time to get a device approved for new uses. However, it is illegal for medical companies to actively promote off-label uses.

The Medtronic Infuse Bone Graft lawsuits may take the form of a group lawsuit like multidistrict ligation (MDL) or an Infuse Bone Graft class action lawsuit. Group lawsuits like an Infuse Bone Graft class action lawsuit and MDL are designed to allow a group of plaintiffs to seek legal redress against a common defendant. MDLs and class action lawsuits save resources for everyone involved by streamlining dozens, hundreds, or even thousands of individual grievances into a single coordinated legal process. MDLs are more common than class action lawsuits for drug and medical device lawsuits, since class action lawsuits typically start out as group lawsuits, while MDLs start out as multiple individual suits filed across different jurisdictions, which are later coordinated into a single group.

In general, Infuse bone graft lawsuits are filed individually by each plaintiff and are not class actions.

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An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as nerve damage; excessive bone growth; chronic pain; difficulty breathing, swallowing, and speaking; male sterility and other uro-genital injuries. See if you qualify to take legal action by filling out the short form below.

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