http://www.redflagsweekly.com/second_opinion/2003_jul10.html

SECOND OPINION

July 10, 2003

BREAST IMPLANTS BELONG IN THE QUACKERY MUSEUM

By Nicholas Regush

The other day, I came across a health news story from BBC News, headlined, "Museum of Health Madness." The focus was the Museum of Questionable Medical Devices in the U.S. I learned that, "its founder…scoured the collections of the American Medical Association and Food and Drug Administration for the most bizarre adverts and machines." Among them was the "phrenology" machines, you know, the ones designed to read bumps on your head. And there was the "Auto-Hemic serum," which was supposed to be a cure for "laziness, ugliness, frigidity and many other things." And so on.

But where were the breast implants? Surely anyone who has ever impartially scoured the collections of information at the FDA on breast implants (namely, the feeble attempts still being made by manufacturers to show their products are safe) would realize that bags of silicone or saline qualify for the quackery museum. There never was any credible science available that could support the widespread implantation of these devices into women’s bodies. And as far I’m concerned, there still is no credible science to show these devices are safe, both short-term and long-term. There is only a ton of PR and vested interests at play that amount to treating women as fodder for the enhancement of the egos and bank accounts of science-challenged cosmetic plastic surgeons and their ilk.

In 1992, the FDA declared a moratorium on breast implants due to the lack of scientific support for both safety and efficacy, but since then, due to huge PR from certain elements of the medical community, and sloppy science reporting and mainstream press obsession with large breasts, these medical devices have been making a big comeback. And, indeed, the FDA is seriously considering lifting all restrictions on breast implants and this move could come as early as this fall.

How blind we become in the face of strong PR and FDA incompetence.

For example, over a ten-year-period (until about 1992), the Meme breast implant, one of the most popular brands, had a foam covering that was made of industrial foam, the kind used in furniture upholstery. I know this well because I was the journalist who first reported on this travesty.

Even though the Meme had been implanted in more than 200,000 women, the manufacturer of the Meme had incomplete knowledge about the foam’s chemical structure and the way the foam was produced.

One of Cooper Surgical’s senior people called a manager of product control at Scotfoam Corporation of Eddystone, Pennsylvania, and asked if the Meme’s foam cover could release a toxic chemical known as 2-4 toluene diamine.

Yes, it could, but why do you ask, the Scotfoam manager replied.

When I checked up on this issue, the manager told me that he was surprised to learn from Cooper Surgical that the polyurethane in question — which was used in oil filers, furniture and carburetors — was being used in a breast implant.

"They had been using our foam for many years and it was the first time that I or anyone else at the company had heard about it.," he told me.

While Scotfoam had conducted basic tests to show the polyurethane could release small amounts of 2-4 toluene diamine, the company had no data on the suitability of the product for long-term use in a breast implant or its relationship to "health effects."

In a series of letters exchanged between the two companies, dated from January 11 to August 3, 1988, the Meme’s manufacturer indicated its desire to conduct basic studies on the polyurethane, which would categorize its chemical stability. To that end, Scotfoam agreed to provide Cooper Surgical with the polyurethane’s ingredient list.

When Bristol-Myers Squibb (the latest Meme manufacturer) suspended sale of the Meme in April 1991, their studies of the polyurethane cover were barely under way.

How soon we forget.

TO READ AN INVESTIGATIVE STORY ON BREAST IMPLANTS, INCLUDING THE MEME BY NICHOLAS REGUSH

TO READ A MORE RECENT TESTIMONY BEFORE CONGRESS ON BREAST IMPLANTS