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Jewish World Review April 11, 2005 / 2 Nisan 5765

Steve Young

Steve Young
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Consumer Reports

Who are the real boobs here? FDA Should be sure it doesn't make another ugly mistake | Whether for medical or cosmetic reason, when a woman opt for breast implants, she should understand all the risks. The question is, does the FDA? Next week the Food and Drug Administration will hold hearings concerning the possible lifting of restrictions on the sale of silicone gel breast implants with the applications of breast implant companies, Inamed and Mentor. Last year the F.D.A. refused to let these implants back on the market due to concerns over ruptures and leakage. But now they're going to give it another go.

Many of those women, including actresses Mary McDonough (of the TV "Waltons") and Mariel Hemingway, who have suffered related health problems due to the implants will be testifying in Washington April 11-13, hoping that the F.D.A. will continue to hold back approval due to lack of complete medical data and many questions concerning the safety of the implants.

But why would I, a woman loving breast guy even choose to write about something that improves the view and doesn't endanger my well-being? Simple. I have a wife and daughters. I have a mother and sister.

I have many friends who, coincidentally, are female. I would never ever want them to gamble their health. Certainly not for cosmetic reasons. It's ultimately their bodies and their decision but I want to make sure they have ALL the data before they might consider going under the knife.

Now I'm not one to question the credibility of a federal bureaucracy which has admitted allowing medications like Bextra, Vioxx and Celebrex on the market before ALL the data was in, but it does seems that the FDA has not learned that rushing to approval only risks health and lives.

Just last week, the FDA released an internal report that was critical of its oversight of medical device makers. The report concluded that the agency had little idea whether the manufacturers were fulfilling their obligations to conduct required studies that F.D.A. advisory panels require so that doctors will have more data about their safety and effectiveness.

The review concluded that the agency could not find evidence to prove that over half the manufacturers had even perform the required studies. Feeling confident yet? Try this.

Dr. Daniel G. Schultz, the director of the F.D.A.'s Center for Devices and Radiological Health, said that he did not know if his agency had followed up to see if any device makers had since supplied missing studies.

Then, not only is there a question as to whether the products themselves work properly, but the FDA, the agency that makes the final judgement on whether the products work properly, does not have a proper data validating system in place that works properly.

Isn't bureaucracy splendidly bureaucratic?

And if you can't verify the validity of the studies how in the world do we know if the studies, many established by the implant manufacturers who have many millions of dollars in profits hanging in the results, are unbiased?

Need one more "who the hell's in charge here" insult to our intelligence?

A plastic surgeon on the F.D.A. advisory panel who voted last year in favor of allowing silicone gel breast implants back onto the market had received a $25,000 grant from the company that makes the devices. An FDA official said the conflict was judged as insufficient to disqualify him to continue on the panel. The surgeon was one of four plastic surgeons on the panel who supported the Inamed's submission.

Plastic surgeons pushing for approval of more plastic surgery. No conflict there.

So while Ms. McDonough and those wanting to make sure all safeguards have been heeded before placing our women in harms way plead their case in front of the FDA's panel, I wonder not if sufficient safeguards are in place, but how the hell the FDA has the guts to even make a judgement at all. A judgement that may one day affect your wife, your daughter, your mothers, your sisters, your best friend.

I'm sure President Bush wouldn't take the chance with Laura or Barbara or Jenna. As the President has reminded us more than once, when there is so much confusion, let us err on the side of life.


JWR contributor Steve Young is author of "Great Failures of the Extremely Successful: Mistakes, Adversity, Failure and Other Stepping Stones to Success," and can be heard on Los Angeles's KTLK AM 1150, Saturdays 1-4 PM. Blog at Comment by clicking here.


© 2004, Steve Young