Companies in Tennessee and elsewhere that manufacture medical devices are required to inform potential patients of the possible risks associated with their products. However, some might not always receive all the necessary information about a device prior to making a decision, especially when these concerns are concealed. Those who suffer serious harm due to defective medical devices may wish to know about their options for seeking restitution, especially if they were unaware of the level of risk involved.
The Food and Drug Administration has strict guidelines pertaining to the reporting of risks associated with medical devices. However, recent reports suggest these guidelines might not always involve a need to inform consumers of possible dangers. According to reports, the FDA has allowed some manufacturers to report possible risks via documents that were never made available for public view.
Reports indicate that the problems that were concealed in this manner pertained to possible risks associated with a variety of devices, such as defibrillators and mesh implants. According to these reports, patients were not the only ones left in the dark, as even doctors were denied access to information on possible risks of certain products. The investigation indicates that certain risks have been concealed for decades and in some cases involved the possible development of health concerns such as cancer.
Defective medical devices can pose a significant threat to a person's health. Those who suffer severe harm or lose a loved one due to the negligence of a device manufacturer could benefit from speaking with an attorney for guidance on how best to approach the situation. An attorney in Tennessee can evaluate the circumstances a client is facing and assist in pursuing restitution through a claim against the party or parties deemed responsible.