Hi Mike,I just received a letter from the FDA August 11, 2008. It states that in reviewing existing events, FDA has determined that many of the adverse events are NOT due to an inherent problem with the implanted material but with where and how the mesh is implanted. If the mesh is not properly placed or properly secured, it can detach and migrate, resulting in painful sequelae. The goal of our labeling review and patient information is to make physicians and consumers more aware of potential adverse events and steps to be taken to avoid such problems. It is important to keep in mind that FDA does not regulate the practice of medicine, which is overseen by the state, nor does the Agency specify what type of training a surgeon must have to make use of these meshes in their practice.
The letter was delivered to Senator Casey. I sent him letters in March. I just typed the last two paragraphs. The typed name at the bottom is from Stephen R. Mason. But the person who signed it, I can't make out their signature. My complaint is against the Bard Perfix Hernia Plug of Murray Hill, New Jersey.
I have info for your reply letter to Mason. I saw the same letter written to someone else.
There is no way the FDA can make that determination from the adverse event reports.
Contact me at miamiblog @ bellsouth.net .