FDA loophole leads to approval of defective products

If you are like most New York consumers, you probably assume that a Food and Drug Administration-approved product has been properly tested and is now considered safe. Unfortunately, that is not always the case. For example, about 90 percent of the medical products and devices that are on the market have been approved by the FDA through the agency’s 510(k) process.

But under a loophole in that process, a product that is ‘substantially equivalent’ to one that has previously been approved by the FDA must also be approved, automatically, no questions asked. Because this is the case even when that earlier product has been recalled or has otherwise been shown to be harmful, the loophole results in many defective products making their way to the market. To remedy this dangerous situation, a number of federal lawmakers are currently working to pass a law which would effectively close that loophole.

The movement to close the approval loophole was largely motivated by the vaginal mesh products manufactured by Johnson & Johnson. More than 300,000 women have reportedly used the device to treat weakened pelvic muscles, and Johnson is now facing hundreds of products liability lawsuits from patients who have suffered internal injuries as a result of the defective product.

Johnson’s vaginal mesh was approved under the FDA’s 510(k) loophole based on a similar product manufactured by Boston Scientific in the 1990s. Although that earlier product was recalled due to safety concerns, it was still able to be used as a “substantial equivalent” of Johnson’s mesh. Hopefully, the House bill will pass, making sure that situations like this no longer happen in the future.

Source: Bloomberg, “Medical Device Loophole Needs Closing by Congress, FDA Device Chief Says,” Alex Nussbaum, Feb. 28, 2012