It became apparent to me on the table that things weren’t going as the specialists anticipated. It turns out the imaging clearly demonstrated that the blockage was only 70-75 percent, and not the 80-90 percent previous imaging had indicated. That turned out to be very significant, as the FDA only allows the stents to be used in patients like me when the blockage is 80 percent or greater.(Read the full text of "FDA Takes Over in the OR".)
Even though the specialists felt I needed the stent to correct my problem, they were not allowed to put it in. [Emphasis mine. -- PSH] So after three hours of intense work by a great medical team, and even though I was already on the operating table ready for the full treatment, the doctors had to pull out without doing anything other than the angiogram. They faced serious sanctions by the FDA had they continued as planned with the actual correction of my medical problem.
The FDA claims to be protecting patients against unscrupulous doctors and medical device makers. However, it appears that what patients really need is protection against the FDA.
(Via R.K.)
Update: Reader J.S. correctly points out that the FDA does not directly regulate the practice of medicine. However, it does set the legal climate in which uses of certain devices in certain settings are permissible (or not).
For instance, the FDA might authorize the use of a device only for certain clinical trials until the FDA gives the green light for broader use. In that case, a doctor who strayed beyond the FDA restrictions might risk lawsuits or penalties from licensing/credentialing boards. Or if the physician has commercial ties with the device maker, his use contrary to FDA rules might viewed as "promotion". In either case, the physician is thwarted from using the device as he deems appropriate, even if that would be in the patient's best medical interests.
Hence, the FDA still exerts tremendous indirect effect on how innovative new devices can be used by physicians, even if it doesn't directly overrule the physician's judgment at the time of treatment.
