The Food and Drug Administration recently released a report indicating medical device recalls have skyrocketed in recent years. While the increase could be a sign of more defective medical devices, some say it's simply evidence that the identification and recall processes are working better.
In its "Medical Device Recall Report", the agency says that the number of Class 1 recalls grew from seven in 2003 to 57 in 2012. But to put that in perspective, Bioflash reports that 2003 had the lowest number of such recalls in any of the 10 years and in each of the following four, there were more than 20.
Medical device recalls may involve machines used in hospitals, like the Puritan Bennett 840 ventilator systems that were recalled last year due to a software problem. But they can also include devices like transvaginal mesh or hip replacements that have been implanted inside patients before the dangers were realized.
Class 1 medical recalls involve those most likely to cause harm.
The Food and Drug Administration classifies recalls of medical devices into three different categories. Class I recalls are the most serious and involve dangerous medical devices that can result in serious injury or even death. These are the recalls we should be most concerned about.
Class II recalls are defined as those that can cause temporary health problems or a slight risk of injury. Class III products are those that violate FDA manufacturing or labeling regulations.
Though Class I recalls represented only about 1 percent of the total number of recalls in 2003, they were 5 percent of these recalls by 2012.
The FDA reports this dramatic increase is due to their efforts to better classify recall efforts, resulting in an increased number of Class I recalls.
Critics say many recalled devices shouldn't be approved for use in the first place.
When it comes to approving a product that will be implanted inside people, one would think a lengthy testing and research phase would be required. But in many cases, that's not necessarily true. The FDA 510(k) system allows manufacturers to fast-track approval when there is a similar product that has already been approved for sale.
In the case of Stryker Rejuvenate hip implants, that's exactly what happened. These implants, used on thousands, were later voluntarily recalled due to early failure rates and design problems. Since the recall in 2012, dozens of patients have filed suit against Stryker for both the Rejuvenate and ABG II hip replacement systems for injuries like dislocation, revision surgery, pain, and immobility.
For thousands of women living with transvaginal mesh pain, the problems of a defective medical device are all too real and the realization that the devices were dangerous came too late. These products are implanted in women to help treat urinary incontinence and pelvic organ prolapse, but have left many women with symptoms far worse.
When a medical device is recalled, it's not the same as a general product recall-you can't just send in the device and get a replacement. The effects of dangerous medical devices can be life-changing for patients, as what was supposed to improve their lives causes even more pain.