Airline passengers, cell-phone users and cable-TV customers enjoy more consumer protections than patients who have life-sustaining medical devices, a prominent cardiologist writes in today's New England Journal of Medicine.
Fridley-based Medtronic Incorporated's recall of a popular heart defibrillator lead in October underscores serious flaws in the way government regulators track devices and the "urgent need" for legislation to protect consumers, according to Dr. William Maisel, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston.
Maisel uses last year's recall of Medtronic's Sprint Fidelis heart defibrillator lead to illustrate his opinion piece, which is occasionally critical of the way the medical technology company and the Food and Drug Administration (FDA) handled the matter.
"The narrative is incomplete and omits facts that are essential to any full accounting or analysis of the events and their ramifications," Medtronic said Wednesday in a prepared statement.
Medtronic stopped selling the leads because some were found to fracture inside the body, which could cause the defibrillator to stop working or inappropriately shock patients, a sensation that feels like a kick in the chest. Five deaths may be linked to malfunctions.
Implantable cardioverter defibrillators (ICDs) are stopwatch-size computers that shock an errantly beating heart back into rhythm. The devices consist of a pulse generator with a battery that is implanted beneath the collarbone, connected to the heart with two or three wire leads.
Maisel wrote that when the Sprint Fidelis lead was approved by the FDA in 2004, the device was never tested on humans, so there was no clinical data to show whether it was safe. Medtronic disputes that, saying that Sprint Fidelis was tested on 160 patients before it was sold in the United States.
The FDA permits this type of approval, but only if the device is similar to one already cleared by the agency -- in this case, another Medtronic lead called Quattro.
That approval process is controversial in some circles.
"Congress needs to close the loophole that allows manufacturers to introduce new products that [support or sustain life] without full testing and peer-review by an outside panel of experts," said Dr. Robert Hauser, senior consulting cardiologist with the Minneapolis Heart Institute Foundation and a critic of the FDA. "Fidelis highlighted the weakness of the current regulation."
FDA process criticized
Once it was available for sale, the Sprint Fidelis lead proved popular with doctors. Thinner than earlier products, it was easier to snake through veins to the heart.
Since 2004, about 90 percent of Medtronic defibrillators that were implanted used Sprint Fidelis leads, which became the top seller in cardiology. At the time of the recall, about 268,000 had been used worldwide.
By early 2007, many doctors had stopped using it, after seeing problems in some patients. In March last year, Medtronic notified doctors about the fracture problems, but maintained that Sprint Fidelis' performance was "in line with other Medtronic leads."
Maisel notes that the company was operating with severely limited information, but continued to sell the leads. Even though the leads had been implanted in thousands of patients, "the available post-marketing data were insufficient to provide a definitive conclusion about whether there was a performance problem," he wrote.
Although Medtronic continued to maintain publicly that the Sprint Fidelis leads were performing at acceptable levels, the company submitted an application to the FDA in May to change the way it was designed and manufactured, Maisel wrote. That application was approved by the FDA.
But patients and doctors were not aware of changes to the leads, he said. Plus, leads made before the changes were still used on patients. Medtronic said Tuesday that the changes were unrelated to problems that led to October's recall.
"It really highlights the holes in the regulatory process when a manufacturer can continue to market a device while at the same time trying to figure out what's wrong with it," said Hauser, one of two Minneapolis doctors who went public in 2005 after a patient died when a Guidant Corp. defibrillator malfunctioned.
After five deaths, and a 2.3 percent fracture rate 30 months post-implant, Medtronic stopped selling the leads in October. Several lawsuits were filed by patients, some claiming that the company should have pulled the product off the market sooner.
In a prepared statement Wednesday, Medtronic defended its actions in the Sprint Fidelis recall as "entirely appropriate based on the information and facts we had. ... We believe our communications were appropriate and timely."
The company says its actions met FDA guidelines, as well as recommendations from a group of cardiologists called the Heart Rhythm Society, which were crafted after high-profile defibrillator recalls in 2005 -- primarily by Guidant (now part of Boston Scientific Corp.). Medtronic also consulted with an independent quality panel -- doctors paid by the company for their time and travel expenses -- to help in its decision process with the Sprint Fidelis lead.
Although many cardiologists say public disclosure of a device's safety record is overwhelming and alarming to patients, Maisel argues that patients should be educated about potential risks before treatment, as part of the informed-consent process.
The FDA, he adds, is failing in its mission to protect public health, saying that it does not disseminate accurate, science-based information to the public. An FDA spokeswoman could not be reached Wednesday for comment.
Maisel says that congressional action is needed, because "essential consumer protections are currently lacking." The vast majority of medical devices approved by the FDA involve no consumer input, he notes.
Safety oversight shouldn't be left to device manufacturers, he argues, because they have an "inherent financial conflict of interest" and a "stronger legal obligation to their shareholders" than to patients.
"Medtronic is a company that has, for 50 years, put patients first," company spokesman Rob Clark responded.
Janet Moore • 612-673-7752
