Medtronic and FDA Face Scrutiny on Safety Issues
Once again, our less than vaunted FDA is facing heat for its handling of safety concerns related to Medtronic defibrillators.
Medtronic announced that its Sprint Fidelis leads fractured in a statistically significant number of its devices. Almost a quarter of a million people have these devices implanted in their chests. Why did the FDA delay taking action? Party politics and a general lack of concern for anything other than the
profits of big pharmaceutical device manufacturers like Medtronic. How little did the FDA care about consumers? They accepted animal testing in lieu of the normal human testing before green lighting Medtronic to sell the Sprint Fidelis. Below is the entire article.
www.ReyesLaw.com
profits of big pharmaceutical device manufacturers like Medtronic. How little did the FDA care about consumers? They accepted animal testing in lieu of the normal human testing before green lighting Medtronic to sell the Sprint Fidelis. Below is the entire article.
Medtronic and FDA Face Scrutiny on Safety Issues©2007 Angel Reyes
By ANNA WILDE MATHEWS and THOMAS M. BURTON
October 17, 2007; Page B7
Medtronic Inc.'s decision to stop selling potentially defective defibrillator leads has prompted scrutiny of the devices and of how safety concerns about them were handled by the company and the Food and Drug Administration.
Plaintiffs attorneys, a consumer group and Iowa Sen. Chuck Grassley are examining the history of the Sprint Fidelis leads, which are electrical wires that connect the hearts of patients to the defibrillators implanted in their chests.
On Monday, Minneapolis-based Medtronic disclosed that the Sprint Fidelis wires have fractured in about 2.3% of the 268,000 models made, 235,000 of which are still implanted in people. The company said the fractures may have contributed to five deaths.
In early signs of the pressure likely to come for Medtronic and the FDA, Mr. Grassley, a Republican, last night sent letters to the company and the agency asking for more information about the leads. Separately, consumer group Public Citizen argued in a letter that the company and agency should have taken action sooner.
In addition, a group of plaintiffs attorneys, which has been a leader in major heart-device lawsuits, filed suits against Medtronic related to the Sprint Fidelis leads in federal court in Minneapolis and Puerto Rico, according to Hunter Shkolnik, one of the lawyers.
The investigations are likely to again focus attention on the FDA's oversight of medical devices, which are regulated under different standards than drugs. For instance, the Sprint Fidelis leads, which went on the U.S. market in 2004, weren't required to be tested in humans before they won FDA approval. Previous versions were tested in humans, but the Sprint Fidelis models weren't different enough from those earlier iterations to require human trials, the FDA said.
Medtronic says it did start clinical trials for two of the four Sprint Fidelis models before they were sold in the U.S., one in 80 patients and the other in 81 patients, but didn't include these in its FDA application because they weren't required. The devices "passed the objectives of the study," which wasn't designed to assess long-term fracture risk, a Medtronic spokesman said.
Medtronic said in a letter to physicians this March that its investigation suggested that "variables within the implant procedure may contribute significantly to these fractures," an issue that potentially would arise only when doctors actually placed the devices into humans.
Before approving the Sprint Fidelis models, the FDA reviewed results from animal tests and extensive engineering "bench" studies, including 400 million repetitions of a bending motion designed to answer questions about the devices' strength, said Megan Moynahan, chief of the FDA branch that oversees defibrillator leads. Because the fracturing issue is "extraordinarily rare," a human clinical trial was unlikely to find it, she said.
Ms. Moynahan said the agency began watching the devices more closely in February. But "the lead didn't appear to be performing any differently" than other similar products, she said, and there wasn't a clear signal of a problem. "We've had this closely on our radar and our concern has been building," she said."
Medtronic said in a statement that when it "had the appropriate information to make a decision regarding the Sprint Fidelis defibrillation lead, we did so ... with patient safety and well being as our primary concern."
Write to Anna Wilde Mathews at anna.mathews@wsj.com4 and Thomas M. Burton at tom.burton@wsj.com5.
www.ReyesLaw.com
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....and what say you about Guidant's Gore defib lead tested on 12 sheep?
I agree we need longer term studies for hardware that is sometimes difficult and risky to remove but apply the standard across the board.
I say thank goodness that Medtronic applied their resources to identify further trends for failure. When will St Jude's Riata "perforator" get the same attention?