Prior to my own failed medical device experience, I had all faith in our FDA. I took their word for it and believed they had the best interest of all american's safety at heart. Never in a million years did I have any reason to doubt that the stamp "FDA approved" meant anything other than "Safe." Now I'm unsure and it scares the hell out of me that American physicians, our doctors, also trust the FDA stamp of approval.
Let me start off by saying that I'm all for innovation and quickly bringing new medical technology that benefits the majority to market. I actually commend the efforts of FDA regulators working to guide industry on their path to approval. However, I fear some may be taking advantage of the system and playing favorites.
One example pertains to the controversial female sterilization device known as Essure, and my research reveals troubling information. I wanted to know WHY and HOW?? Why was Essure given special privileges and fast tracked to market? How was the manufacturer always able to predict and obtain FDA approval for its original PMA submission and its subsequently filed supplements. It appears they've always had friends in high places, giving them an extreme advantage over other device manufacturers developing similar technologies.
Have you ever wondered how silicon valley has raised to medical device "stardom" in recent years? Since the very beginning I noticed a trend that tied in FDA officials, representatives from CMS (Centers for Medicare & Medicaid Services), New Enterprise Associates (Venture Capitalist Firm that funded Essure's start-up), and Essure developers to Stanford University and its bio-design team. In fact, in recent years the FDA has formalized its collaboration with Stanford to "safely" streamline medical devices to market.
Recently I discovered a trade association called Medical Device Manufacturers Association (MDMA) based in Washington DC. MDMA provides a platform for the medical device industry to maintain close relationships with key members of Congress, senior staff at the FDA and CMS, and Venture Capital Firms. They frequently hold conferences in fancy hotels conveniently located close to either our nations capital or near the Stanford campus.
One can't help but wonder what goes on behind closed doors. Innovators and entrepreneurs in the medical device industry, particularly and especially from Stanford, literally have everything they need at their fingertips. In the case of Essure, Conceptus had easy access during pre and post market surveillance to upper FDA officials, Venture Capital Funds, and key CMS officials to grant them the favorable CPT code they desperately needed to gain wide spread market acceptance.
Realizing this after the FDA has received over 10,000 formal adverse event complaints pertaining to Essure without taking adequate action to protect public safety, one can't help but feel deceived and question the credibility of Essures approval and processes. It's obvious that there is something more to read between the lines in this instance and Conceptus was given an unfair advantage.
There needs to be further steps taken to improve the transparency of these meetings in order to maintain the publics trust while still inhibiting innovation and promoting streamlined access to medical devices desperately needed to save lives. Closed doors only lead to open minds full of distrust.