Let's be cautious on breast implants 

By Steve Young

Guest Columnist

Sunday, April 10, 2005 - I understand from most of the women I've ever known that they are delighted to be in possession of ample breasts, almost as delighted as men are for women having them. And when the breasts don't come in desired size or shape au natural, many women opt for implants. But whether man or woman, does that delight outweigh the risk of death?

Next week, the Food and Drug Administration will hold hearings concerning the possible lifting of restrictions on the sale of silicone gel breast implants pending the applications of breast implant companies Inamed and Mentor. Last year, the FDA refused to let these implants back on the market due to concerns over ruptures and leakage. But now it's going to give the product another go.

Many of the women, including Valley resident Mary McDonough (of TV's "The Waltons") and actress Mariel Hemingway, who have suffered related health problems due to the implants, will testify in Washington on April 11-13, hoping that the FDA will continue to hold back approval due to lack of complete medical data and many questions concerning the safety of the implants.

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 were 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 FDA 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 performed the required studies.

Dr. Daniel G. Schultz, the director of the FDA'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 does not have a proper data-validating system in place that works properly.

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?

A plastic surgeon on the FDA 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 Inamed's submission.

Plastic surgeons pushing for approval of more plastic surgery. No conflict there. So while McDonough and those wanting to make sure all safeguards have been heeded before placing our women in harm's way plead their case in front of the FDA's panel, I wonder not if sufficient safeguards are in place, but how the FDA has the guts to even make a judgment at all. A judgment that may one day affect your wife, your daughter, your mother, your sister, your best friend.

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

Steve Young is author of "Great Failures of the Extremely Successful" and can be heard on Los Angeles's KTLK AM 1150, Saturdays 1-4 PM.