Other complications might include, but not limited to, infection, bleeding, anesthesia issues, and hardware problems to name a few. Fortunately, most complications associated with spinal fusion occur infrequently because they are well recognized, reported on, and controlled for.
But what happens when patients aren’t given full disclosure on a product’s risks and benefits? This is a question currently sitting in the lap of the Medtronics corporation.
In 2002, Medtronics released a product designed to stimulate bone growth following spinal fusion surgery. The product is called Infuse, a bone morphogenetic protein (BMP) that has been used in over 500,000 patients.
Infuse has lately come under tremendous scrutiny, with allegations asserting that researchers failed to report certain potentially dangerous and life threatening complications. The story follows.
Complications Following Spinal Fusion Surgery
John Fauber of the Journal Sentinel reports…
Hidden under Tom Engel’s skin is a small device that continuously pumps a morphine-like drug into his spinal column and ultimately into his brain.
Without it, his back pain would be unbearable.
Before getting the pump, Engel, 65, underwent two surgeries in which a product known as Infuse was implanted in his spine in an effort to relieve his pain. The first surgery, in 2002, was for a technique approved by the U.S. Food and Drug Administration. The second, in 2004, used the product in an unapproved “off-label” way.
His pain only grew.
“He doesn’t even go to church anymore,” said his wife, Rita. “We went to church all our lives. He can’t walk that far, and the drugs put him to sleep.”
Engel’s experience puts him at the center of a growing medical controversy surrounding Infuse and Medtronic, the company that markets it. The product’s growth to $700 million a year in sales was built on questionable research by doctors with financial ties to Medtronic, relationships that were often not fully disclosed in articles published in medical journals.
Now, the company faces investigations by the U.S. Justice Department, a U.S. Senate committee and a group of reform-minded surgeons. The Senate investigation and an unprecedented exposé of the product in the Spine Journal followed stories by the Journal Sentinel and its partner MedPage Today that revealed Medtronic paid out tens of millions of dollars in royalties since Infuse came on the market to prominent spine surgeons around the country who wrote favorable articles for medical journals.
Their medical papers often failed to link the product to serious potential complications, including the formation of unwanted bone in the spinal canal, dissolving bone, radiating leg and arm pain, infections, increased cancer risk and sterility in men.
The surgeons did not receive royalties for Infuse.
The product, a genetically engineered protein, was approved in 2002 for narrow use in the lower back. It seemed like a triumph of biotechnology that would spare patients from a minor operation to harvest a small amount of their own hip bone for use in spinal fusion surgery.
But today as much as 80% of Infuse sales are tied to unapproved uses – ones that were not rigorously tested and proven to be safe and effective, studies show.
More than 500,000 people have gotten Infuse implants since the product came on the market, according to the company. Doctors say many of them have benefited from it. But others have suffered.
Engel, who lives in the Milwaukee area, can attest to how such surgeries led to unrelenting pain. He now has what is known as failed back surgery syndrome, according to his doctor, Don Harvey.
It is common condition at pain clinics around the country, said Harvey, a pain specialist with Advanced Pain Management in Sheboygan.
“We have a national epidemic of that,” said Harvey, who was not involved in Engel’s spine surgeries.
He said 10% to 15% of the patients he sees have failed spinal fusions.
Harvey said many orthopedic surgeons were quick to start using Infuse because the medical literature was filled with reports of how well it worked – articles that often were authored by doctors who had financial relationships with Medtronic.
“This is an ugly story for the practice of medicine,” he said. “An awful lot of really good (doctors) are probably second-guessing themselves as to having used Infuse.”
In Engel’s case that tale became a cruel irony: The morphine pump in his abdomen also is made by Medtronic.
Like Engel, John Lane of O’Fallon, Mo., is not likely to show up in patient testimonials for Medtronic.
In an X-ray image, Lane’s neck looks bionic – a series of rods, screws and other hardware affixed along his spine.
Lane, now 46, already had undergone surgery on his neck without Infuse when he went to see Timothy Kuklo, an orthopedic surgeon who had come to Washington University in St. Louis from Walter Reed Army Medical Center where he had retired as an Army orthopedic surgeon.
Though the first fusion surgery in 2006 had failed to relieve Lane’s pain, Kuklo was reassuring, Lane said. Kuklo told him there was a 95% chance that he would get at least 90% pain relief, he said.
“He basically said, ‘I can fix you,’?” Lane said. “?’This is no big deal. You are going to be well.’?”
Kuklo’s remedy: perform another cervical fusion, this time with Infuse, using it in an off-label and potentially risky manner that, months earlier, had been the subject of an FDA warning after reports of life-threatening swelling in the throat.
A few months after Lane’s 2009 surgery, allegations surfaced that Kuklo had forged the signatures of several co-authors on a positive 2008 study involving the use of Infuse on severe shinbone fractures in combat soldiers in Iraq.
In March 2009, J. Scott, the editor of the Journal of Bone and Joint Surgery (British), where the study appeared, took the unusual step of retracting the paper from the scientific literature and banning Kuklo from publishing future research in the journal.
Washington University later found that Kuklo had committed research misconduct, but it did not find sufficient evidence that he falsified data.
In news accounts at the time, Medtronic acknowledged paying Kuklo about $800,000 between 2001 and 2009. The company would not confirm that figure for this story.
Kuklo, who now practices at the Colorado Comprehensive Spine Institute in Englewood, Colo., declined to comment.
His attorney, Henry Dane, said the Army’s investigation of Kuklo was one-sided and based largely on unsubstantiated allegations by a junior colleague. He said Kuklo was not allowed to obtain a lawyer to represent himself.
“Despite the unfortunate fallout from his relationship with Medtronic, Dr. Kuklo is a distinguished and dedicated medical researcher and clinician who has published 120 peer-reviewed journal articles and chapters,” Dane said.
A letter obtained by the Journal Sentinel and MedPage Today indicates that as of June 22, Medtronic’s activities with Kuklo and other doctors still were being investigated by a federal grand jury in Boston. Grand juries are secret. More recent information could not be obtained.
The letter was sent by Secretary of the Army John McHugh to U.S. Sen. Charles Grassley (R-Iowa), who is the ranking member of the Senate’s Judiciary Committee.
In June, Grassley, also the senior member of the Senate’s Finance Committee, and U.S. Sen. Max Baucus (D-Mont.), chairman of that panel, began an investigation into whether complications with Infuse were not reported in journal articles co-authored by doctors with financial relationships with Medtronic.
McHugh wrote that a criminal investigation unit of the Army was supporting the federal grand jury investigation, and other agencies and federal investigative units were interviewing witnesses and reviewing documents.
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