Medtronic’s Infuse Causes ComplicationsPublished: Jul 30, 2014 in Defective Products
A medical drug and device, like Infuse, taken to market with limited testing and time spent monitoring the long-term effects of its usage, may inadvertently cause extensive injury or death to patients, says Alabama liability attorney Keith T. Belt.
Three years after back surgery, Grace Nestler-Bramm learned that a drug, Infuse, designed to repair her spine was causing new bone growth, growth that was wrapping around the spine and compressing nerves, but by then it was too late since the bony overgrowth associated with Infuse already had done irreparable damage.
The Cedar Grove, Wis. resident is now disabled by pain and has difficulty walking — often needing a cane or wheelchair when she leaves her home and doctors have told her that additional surgery to fix the problem would be too dangerous.
A Journal Sentinel / MedPage Today analysis of U.S. Food and Drug Administration data found more than 6,500 reports of Infuse-related problems have been registered with the agency’s medical device reporting system since 2002, the year Infuse was approved. Moreover, Infuse is not an inexpensive treatment option: a paper published in the Spine Journal in January found that use of BMP-2 increased the typical hospital charge by more than $13,000 per patient, more than $900 million in total, from the years 2002 to 2008.
Infuse was approved as a combination product, one that includes both a drug and a device. Surgeons implant a collagen sponge carrier, a threaded metal cage, and BMP-2. The FDA approved Infuse after markedly less testing on patients than other combination products and biologic drugs, even though serious concerns about its safety were raised before its approval.
“It appears the clinical trials, unfortunately, were not designed to adequately test for safety of the product,” said Bradley Weiner, MD, chief of spinal surgery at the Methodist Hospital in Houston. “We only learned of the harms as they emerged over time.”
Last June, more than a decade after Infuse was released, independent researchers writing in the Annals of Internal Medicine concluded the product offered little benefit over conventional spine surgery and said it may expose patients to serious harms. By then it had been implanted in more than 1 million people worldwide
That determination followed an investigation by the Journal Sentinel and MedPage Today that revealed a small group of spine surgeons who received millions of dollars in royalties from Medtronic had co-authored papers that failed to note the link between the product and several serious complications. In some cases, the medical journals publishing the papers didn’t fully disclose Medtronic’s financial relationship with the authors.
The complications include increased risk of cancer, retrograde ejaculation, which can cause sterility, a variety of serious complications when used in the neck, and one that is showing up in many of the lawsuits — excess bone growth.
The FDA approved Infuse not as a life-saving drug or even as one that promised to dramatically reduce disability. It was approved as an alternative to traditional spinal fusion surgery that often required harvesting a small amount of a patient’s own hip to create a fusion.
Testing of new biologic agents generally requires clinical trials with 1,000 to 3,000 people, but in allowing Infuse on the market, the FDA treated it as a combination device, rather than as a biologic agent, with only 277 patients in the clinical trial. In addition, Infuse was approved in a “non-inferiority” trial, meaning Medtronic did not have to prove it was any better than the traditional treatment resulting in Infuse go on the market with less safety testing than other biologic drugs.
However, even before its approval experts testified that there was a great potential for harm if Infuse were used “off-label,” with research now indicating that 80% or more of Infuse use has been in surgeries for which it was not tested and approved.
Medtronic spokeswoman Cindy Redman said the company has continued to gather data on the product, including commissioning a 2011 independent review of safety and effectiveness data by two outside research teams. However, the reports by the two groups of independent researchers raised serious concerns about Infuse.
For instance, researchers from Oregon Health & Science University said they found substantial evidence of biased reporting on BMP-2 in medical journals and no evidence that it is more effective than the traditional method used in spine surgery.
Those now suing the company face a daunting battle — a wrinkle in federal law known as pre-emption, which makes it difficult to sue medical device companies over products that have received FDA approval. A combination of federal law and Supreme Court decisions essentially say that medical devices should be readily available to treat patients who have life-threatening or potentially disabling conditions. And once a device undergoes the FDA approval process, claims are then barred.
However, those filing suit argued that financially connected spine surgeons acted as paid promoters for Medtronic and induced other spine surgeons to use the product for dangerous surgeries for which it did not have FDA approval, thereby losing its protection from lawsuits.
Individuals who have sued Medtronic include patients such as Christina Ramirez, of Phoenix, who was starting out on a medical career as a pathologist when she underwent back surgery. It wasn’t until 2011, 2 years after the surgery, that she learned she had been implanted with Infuse.
Ramirez says unwanted bony overgrowth caused by Infuse led to nerve impingement and pain so severe that the skin and tissue around her spine “feel like they are literally burning.” She has shooting pain in her hip, thigh, foot, and groin and says she does not know how much longer she can continue working.
Infuse also ended Randall Seltrecht’s career as an EMT and his dream of becoming a nurse, according to his lawsuit. The Ringle, Wis., resident had uncontrolled bone overgrowth after a 2009 surgery with Infuse. He has needed three, painful corrective surgeries since then, and doctors have told him there is nothing more they can do for him, his lawsuit says.
Prior to being implanted with Infuse in 2009, Steven Halpin could walk four to five blocks without pain. Now he can only walk a half block and he can’t perform basic household tasks plus needs to take high doses of pain medications.
The uncontrolled bone growth that was caused by Infuse required a revision surgery because of complications from the product, including unrelenting pain, the carpenter from Genoa City, Wis. says he has been forced into early retirement.
Cefalu, 60, who was born and raised in Milwaukee and now lives in Illinois, developed kidney cancer in 2009 after getting Infuse in an unapproved procedure with BMP-2. Both he and his spine surgeon say they would never have used Infuse had they known about its potential cancer risk.
A study published in April in the Journal of Bone and Joint Surgery found that use of BMP-2 in the neck continued through 2010 despite a 2008 FDA warning against using it in the cervical spine following reports of life-threatening swelling. Using it in the neck significantly increased the likelihood of complications, the study found.
Patients and doctors are not required to file adverse event reports with the FDA, but references to excess bone growth appear in hundreds of reports filed with the FDA.
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