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Problems for Infuse in study

-New York Times

07/01/2009 - Patients who received a bioengineered protein during spinal fusion procedures to correct neck pain had far more complications than patients who did not get it, according to a study released Tuesday.

The study, published in the Journal of the American Medical Association, reinforces previous concerns about the use of the proteins in fusion procedures to treat upper spine, or cervical, pain. The substances studied, sold primarily by Fridley-based Medtronic under the brand name Infuse, are not federally approved for cervical procedures, although surgeons are free to use them for that purpose.

The new study, by researchers at Brigham and Women's Hospital in Boston, reviewed hospital records from 2002 to 2006.

Another form of the bioengineered protein is sold by a company called Stryker as OP-1 Putty.

Bioengineered proteins, which mimic natural substances that promote bone growth, were first approved in 2002 by the Food and Drug Administration but initially only for use in spinal fusions to alleviate lower, or lumbar, back pain.

Last year, the FDA issued an alert after receiving reports of life-threatening complications following cervical fusion procedures involving the proteins, including breathing difficulty and swelling of the neck.

While use of the products in such operations has since fallen, one expert said the new report should persuade doctors to stop using them in anterior cervical fusions, as the procedure is known. The use of a bioengineered

protein should be "discontinued either permanently or until further information becomes available regarding how to use it safely," said Dr. Thomas Einhorn, chairman of orthopedic surgery at Boston University.

The products' use in cervical fusion procedures is a small component of their total sales, which reached an estimated $760.3 million in 2008, with Medtronic's share the larger one, according to Millennium Research Group.

Marybeth Thorsgaard, a Medtronic spokeswoman, said the company was close to completing a clinical trial involving the use of Infuse in anterior cervical fusion. In a statement, she said the trial would help address how the procedure, if approved by federal regulators, "should be appropriately managed to minimize complications."

Some experts have speculated that the adverse effects were dose-related. Medtronic has also noted such effects in Infuse's warning label.

Dr. Kevin Cahill, who led the study released Tuesday, said he believed complication rates were actually higher than those reported in the study because complications often occurred after a patient left the hospital.

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