When a medical device is approved by the FDA, patients and medical professionals alike assume that the product is going to work as intended. They never believe that something could go wrong. Unfortunately, there is always the possibility of this happening.
California is a long way from Maine, but this story involving a defective medical device has the ability to touch people in every state.
During a surgery at Eastern Maine Medical Center, it was discovered that a product intended to prevent blood clots was defective.
Known as the Cordis Opt-ease Vena Cava Filter, this is put inside a vein that takes blood from the legs to the heart. The filter is in place as a means of catching blood clots, helping to avoid a recurrence of pulmonary embolism.
At this point, it is believed that the device itself is not defective but instead the directions on how to insert it were incorrect. Nonetheless, this led to the FDA recalling the device and making a change to the labeling.
Since this device is used from one side of the country to the next, a nationwide recall was issued. The Eastern Maine Medical Center was given an award by the FDA for catching the problem.
Despite the fact that the FDA takes no chances, defective medical devices can still make their way to patients. In this case, the FDA had no choice but to recall the product.
Anybody who has been injured as a result of a defective product has the right to contact an attorney with experience in this area of the law.
Source: WABI TV5, "EMMC Device Investigation Triggers FDA Recall" John Krinjak, Jan. 29, 2014