The US Food and Drug Administration (FDA) issued a letter to healthcare providers to make sure they are aware of updated warnings and precautions for certain surgical mesh products produced by Becton, Dickinson and Company (BD), which are included in updated product labeling.
FDA also reminded providers that the agency has not determined the safety and effectiveness of surgical mesh products, including the BD products, when used in breast surgery.
In total, BD updated labeling for nine mesh products that are cleared for the repair and reinforcement of soft tissue where weakness exists. The products include:…
