In the clinical trial for Medtronic Infuse, one surgeon pointed out that the emperor was wearing no clothes. Do you remember that story, Kentucky?

In the fairy tale, a young boy points out that the emperor—who has been convinced by a deceptive tailor that his clothing is invisible to people who are stupid or incompetent—really has no clothes on. David Malone, a Tulsa, Oklahoma, surgeon, let the Food and Drug Administration (FDA) know that the emperor had no clothes—that Medtronic Infuse had its limitations, regardless of what everyone else claimed.

What Is Malone’s Story?

David Malone was a surgeon who took part in the clinical trials of Medtronic Infuse Bone Graft. He reported in an interview that one of his patients needed a third operation because the overgrowth of bone irritated the nerve roots.

“It was a pretty amazing biological response,” said Malone. “It grew back even larger than the first time. It got to the point that secretaries in our clinic could look at x-rays and tell who got the BMP (Infuse) and who did not. You could see that much bone growth.”

Malone said that he sent a letter to the FDA explaining his observations, which were read to a 2002 advisory panel hearing about Infuse. Later in the same year, the FDA approved Infuse based on results of another clinical trial, using a different surgical technique.

Medtronic Infuse, used as approved, can give blessed pain relief; but if you are suffering from complications from Medtronic Infuse surgery, contact the Louisville personal injury lawyers at Gray and White Law. Call 502-210-8942 or toll free at 888-450-4456 and set up a FREE, no-obligation, confidential consultation.

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