Warnings Issued By The FDA In Regards To The Latest Defective Medical Device
October 29th, 2013|
October 29, 2013
The Defective Medical Device Lawyers with Ferrer, Poirot & Wansbrough explain manufacturers of medical devices have a responsibility to ensure the safety of the products they introduce to the market. Any failure to do so that results in a patient’s death or serious injury can result in action being taken against the company.
One such action is when the U.S. Food and Drug Administration (FDA) issues warnings to the public about the use of the product. One such warning was recently issued in regards to the St. Jude Amplatzer Atrial Septal Occluder (ASO). The device is used to close holes developed in patient’s hearts; however, in some cases, the device has caused the tissue surrounding it to die and erode, resulting in a need for immediate corrective surgery. These adverse health events have been found to occur in as many as 3 out of every 1,000 patients who have the devices implanted in their bodies.
In response, the FDA has issued several recommendations to both patients and doctors who are considering the use of the device. The agency has also ordered the product’s manufacturer to conduct a study into the product’s safety risks.
The law firm’s team of attorneys is aware of how devastating a Defective Medical Device Injury can be. That is why the firm is here to answer any questions those who have been harmed by such a device may have. Contact us today for a free consultation of your case.