David B. Reath, MD
Knoxville, TN (865) 450-9253
HKB Knoxville Staff

Why I Both Love And Hate The FDA

FDANo arm of the government has had a greater influence on plastic surgery than the FDA, at least during my years of practice. And there is probably not a single plastic surgeon who doesn’t have strong feeling about this. Most of these feelings, I must point out, are negative. I agree with much, well really, almost all of these. However, a recent issue has come to light whereupon the FDA really did come through for us, as plastic surgeons and as patients.

The primary problem is that this branch of the government is political like every other branch, and is expected to make good decisions about the drugs and devices we use. As as physician, I am looking to see decisions made on the basis of science. You can ask anyone in the office about my approach to something new. The first thing I ask for is the science, the studies that have shown effectiveness and safety, not the glitzy marketing pieces. Basically: show me the science! History shows that this has not always been the basis for the FDA’s decisions.The FDA Got One Wrong
The removal of silicone breast implants from the market is a case in point. In the early 1990’s, plastic surgeons raised some concerns about whether or not silicone implants could be linked to  autoimmune disorders. (A good side point is that it was the plastic surgeons who were wanting to understand if there was a problem, not the FDA). They even came up with a name for it: Human Adjuvant Disease. This was shortly followed by a storm of sensational media reports that got everyone whipped up in a frenzy. At that time, the commissioner of the FDA was David A. Kessler, MD, a pediatrician and a lawyer. He was unfavorably disposed towards silicone breast implants and put together a committee to examine the issues around them. In fact, he stacked the committee with people who shared his bias.

However, the recommendations of this committee after they had reviewed the science, was to leave the implants on the market and continue to study them because there was no good scientific evidence that there was a problem. As many of you know, Kessler ignored the advice of his committee and pulled the silicone breast implants from the market in 1992. (They continued to be used in almost every other country in the world). It took until 2006 to get them back on the market. Thankfully we now have them but history will show that this was a poor decision on behalf of the FDA that was politically motivated and not based on science.

The FDA Got One Right
Recently, however, a true success of the FDA’s vigilance has been front page news. Ever heard of the PIP silicone implant?  These were manufactured by a French company who produce both silicone and saline breast implants. While the saline implants were approved for use in this country, the silicone implants were not  This has proved to have been an excellent decision. The PIP silicone implants were filled with industrial grade silicone (not medical grade) and had a much higher rupture rate. At the preset time the government of France is paying for the removal of these implants. Something that will not be a worry for the USA because they were never used here. Thank you, FDA!

The FDA Still Has A Long Way To Go
The larger problem will be how the FDA amasses the science needed, and the timeliness of this in the approval of new drugs and devices. It takes far longer, and many more dollars to have a new drug or device approved in the company because of the requirements of the FDA. I have listened to FDA members discuss the process, and different devices, and I am left with the conviction that many of the concerns of this bureaucracy are off the mark. But in a recent hearing about silicone breast implants attended by several of my colleagues, it is evident that science is rising above political considerations.

Nonetheless, the process of approval is long and slow. One of my close friends, at a meeting with FDA representatives said this: “We will come up with a better breast implant. But it will never be developed in the US, because of the approval process by the FDA. This is something that you must deal with if we are to have the best drugs and devices in this country.”

As you can see, my feelings are mixed. We need an FDA but we need it to be driven by good science. The scientifically based approval process must encourage the production of new  and effective drugs and devices, not make it an impracticality for them to be developed in this country.

All the best,

David B.

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