February 6, 2007

Silicone’s Safety Tested on Women

“Women are essentially the experimental lab rats into whom the so-called new and improved ‘fifth generation’ of silicone will be implanted,” asserts Judy Norsigian, executive director of Our Bodies Ourselves, and Dr. Edward Melmed, a plastic surgeon based in Dallas.

Their op-ed, which appeared in Friday’s Boston Globe, addresses the dangers of silicone breast implants, which the FDA approved in November after a 14-year hiatus, despite lingering concerns about the effect on women’s health and the acknowledgement that the implants will break, most within 10 years.

On top of that, replacement is generally more expensive than the initial surgery and there is an even higher rate of complications. Indeed, the cost from the onset is quite astounding — as is the government’s set of recommendations for women who opt for silicone breast implants. From the op-ed:

In terms of cost, silicone implants are about $1,000 more expensive than saline implants — and this represents just the beginning. The FDA has made it clear that patients will need a breast MRI after three years, and every year after that for the rest of their lives. An MRI for [correction: both breasts] ranges from $1,600 to $5,000. In addition, follow-up surgery to replace a leaking implant is usually more expensive than the initial procedure.

Most troubling is that the FDA endorsement was made without adequate safety assessments. The medical community still does not have a clear picture of how many women have become sick due to a leaking implant. There are also no well-designed studies examining the effect of leaking silicone on breast milk. And there is a significant, unanswered question about the existence of platinum in the breast milk of women with silicone implants — some believing that platinum is dangerous. We should have understood the effects of platinum before approving the product.

Perhaps the greatest indicator that the FDA has proceeded too quickly is that, according to its latest ruling, silicone manufacturers must conduct [correction: two studies of at least 40,000 implant recipients each] over the next 10 years to determine the long-term safety and efficacy of the implants. Should this kind of study not be conducted before giving the green light, not after? Should we not understand the long-term risks before sending a product to market?

This story in the Philadelphia Inquirer, meanwhile, notes that demand for silicone implants is growing — and the trend is toward even bigger implants, with more women now choosing a D cup instead of a C cup. Marie McCullough writes:

In 2005, about 360,000 American women — nine times more than when the FDA restricted implants in 1992 – paid an average $5,000 (more like $6,000 to $10,000 in the Philadelphia area) to get better bosoms. That’s all out of pocket, because health insurance doesn’t cover it.

Year after year, the demand increases, data from the American Society of Plastic Surgeons show.

All told, an estimated 3.7 million U.S. women have gotten bigger breasts — more than the population of Connecticut. Most of them went under the knife after 1992, even though the majority had to get cosmetically inferior saline implants, which were also the subject of safety questions.

The Inquirer also includes statistics from studies that the FDA required of two breast implant manufacturers, Allergan and Mentor:

Allergan, for example, found that 41 percent of first-time implant patients had at least one significant complication within four years, including 23 percent who needed another operation to fix breast hardening, pain, swelling, scarring, asymmetry, rupture or other problems. For patients replacing an implant, the complication rates were even higher – 57 percent.

Mentor had lower reoperation rates – but only three years of data.

“Women tend to accept this sobering reality as the price of what they perceive as beauty,” McCullough adds. And the woman quoted in the story support this. One plastic surgeon says his patients know the risks but “either they’re infinitely optimistic and think, ‘It won’t happen to me,’ or they’re realistic and say, ‘I’ll deal with it when it happens.’”

But this “sobering reality” continues to trouble women’s health activists who have been down this road before.

Dr. Sidney Wolfe, chief of Public Citizen’s Health Research Group, has called the implants “the most defective medical device ever approved by the F.D.A.”

“The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety,’” he told The New York Times last November.

Edward Melmed, the plastic surgeon co-wrote the Boston Globe op-ed with Norsigian, used to perform cosmetic breast augmentation, but he doesn’t anymore. As he explained last month, Melmed reevaluated his pro-silicone position in the early 1990s.

“Most plastic surgeons vehemently deny any connection between health complaints and leaking silicone implants. But I have seen a disturbing number of patients with symptoms, including fatigue, short-term memory loss, joint and muscle pains, skin rashes, disturbed sleep patterns, depression and hair loss, that clear up when implants are removed,” Melmed wrote previously. “Last year, I completed a review of the last 500 gel implant removals I performed, and found that more than half the women had similar symptoms, ranging from mild to debilitating.”

As we said, astounding.


One Response to “Silicone’s Safety Tested on Women”

  1. C Kennedy Says:

    I have the same symptoms mentioned in this and I plan to have my Silicone Mentor Implants removed.

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