Caroselli, Beachler & Coleman, L.L.C.

FDA approving defective medical products?

A product that has for some reason or another failed to be recalled does not mean that the product is safe. Too often defects concerning particular products are not found until attorneys have filed a products liability lawsuit against the manufacturer.

It has come to light that a number of medical implants that probably have been marketed in Pennsylvania have not been recalled by the FDA and probably have been too quickly approved. Such products would include hip implants, surgical mesh, heart valve rings and defibrillator wire leads.

Much has been written about the hip implants and surgical mesh that has been the subject of many recent lawsuits. However, the heart valve rings and defibrillator leads have been approved as well with no more oversight than occurred with the hip implants and surgical mesh. Of note is that the defibrillator leads have been implanted in as many as 79,000 patients and have been associated with as many as 20 deaths.

The FDA has justified a quick process to approve such devices for marketing in part because such devices when working properly can improve or even save lives. However, the quickening of this process can ultimately lead to no clinical testing or FDA oversight.

Since all such products have actually been surgically implanted into human beings, it's quite understandable why patients fitted with such devices would be concerned that no testing has been conducted. When such products do prove to be defective after marketing, at the very least it will lead to patients having to undergo an additional surgical procedure to have such a device removed. It can also lead to severe injury, prolonged suffering and even death.

Source: ProPublica, "Four Medical Implants That Escaped FDA Scrutiny," by Lena Groeger, April 30, 2012

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