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FDA says serious medical device recalls have skyrocketed

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In recent years, New Jersey newspapers have been filled with headlines about recalled medical devices. DePuy hip replacements, pacemakers, and infusion pumps are among the defective devices that have been pulled from the market after thousands of patients received the dangerous implants. These high-profile products are among thousands of defective medical devices that have been recalled recently.

Last week, the U.S. Food and Drug Administration reported that the number of Class 1 medical device recalls swelled by over 900 percent from 2003 to 2012. Class 1 recalls involve defective devices that may cause serious injuries or death. In 2003, just seven Class 1 recalls were issued; in 2012, 57 were issued.

The FDA has attributed the spike in Class 1 recalls to improvements in classifying recalls. The administration explained that more recalls are being accurately placed in the Class 1 category than in earlier years. Nonetheless, the total number of recalls has also skyrocketed--almost doubling from 2003 to 2012.

The rise in the rate of medical device recalls is very troubling, as is the number of repeat offenders. One-third of the companies that were subjected to recalls in 2012 faced more than one recall.

Medical devices can be recalled by manufacturers or by the FDA. A manufacturer should recall a device upon learning that it is defective or dangerous; the FDA orders recalls of devices for similar reasons, but can also order recalls upon learning that a device violates FDA law. A recall does not always mean that a person needs to have the device removed, or stop using the device. But in some cases, particularly when a device is part of a Class 1 recall, the patient may need to have an implanted device surgically removed.

Those who are affected by recalls often do not know where to turn. If you have used or are using a medical device that has been recalled, it may be very important to see a doctor. It is also critical to ensure you understand your legal rights. It can be very expensive to have corrective measures taken in the aftermath of a recall, and victims should not be burdened by this.

Source: Boston Business Journal, "Life-threatening medical device recalls up eightfold since 2003," Don Seiffert, March 21, 2014

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