According to a 2011 report from the U.S. Food and Drug Administration (FDA), the number of “adverse event” reports for medical devices has increased by about 15 percent every year for the last 10 years. If you are a regular reader of our New Jersey personal injury blog, you are likely not surprised by this increase.
In recent months, we have written multiple blog posts about the dangerous and defective medical products that are causing pain, injury and even death to so many people across the U.S. The reasons for many of these problems, we believe, are the failings of the FDA’s current approval and monitoring processes.
In 2005, Johnson & Johnson’s DePuy Orthopaedics sought FDA approval for a new metal-on-metal artificial hip joint. However, under the agency’s 510(k) program, approval was automatically granted and the product went to market without any clinical trials. Instead, the patients were the guinea pigs for the artificial hips, which ultimately proved to be ineffective and harmful. The product was recalled in 2010.
Vaginal mesh products were approved in a similar manner: based on a previous product, despite the fact that the earlier version had little in common with the new device. The lack of testing became obvious when the mesh, which had been implanted in thousands of women to remedy pelvic organ prolapsed or urinary incontinence, began eroding and sticking through the walls of the bladder or vagina in about 15 percent of the women who had received it. However, the FDA and the manufacturers of vaginal mesh continue to maintain that the product is safe.
We will continue our discussion of this topic in a second blog post later this week with a look at two more dangerous devices that have received FDA approval.
Source: Pro Publica, “Four Medical Implants That Escaped FDA Scrutiny,” Lena Groeger, April 30, 2012
