Tits for Tat?

Bush's FDA moves forward on approving silicone breast implants but still stalls on emergency contraception

When a federal Food and Drug Administration advisory panel recommended the approval of one company's silicone gel breast implants this spring—even though some women had testified that the gel oozed out of their eyes, ears, and nipples—one word kept coming up over and over again: choice. A panelist told The New York Times that it was important to give women a choice of implants. "And it isn't to have a choice. It is to make a choice," she said. "We'll be working . . . to allow women to finally have a choice," echoed a representative of the American Society for Aesthetic Plastic Surgery, in The Washington Post. Suddenly everyone was pro-choice, so to speak.

As it happens, choice also figures into another big potential FDA approval this year: over-the-counter emergency contraception. Even as Bush's FDA moves forward on giving women a choice of breast implant types, as it did when it announced on July 28 that the silicone implants were one step closer to being approved, the agency stalls on allowing the purchase of the morning-after pill, known as Plan B, without a prescription.

If Mentor Corporation's MemoryGel implants are ultimately approved by the FDA, which could happen by the end of the year, "women would have a choice again," emphasizes Dr. Richard A. D'Amico, chair of the Breast Implant Task Force of the American Society of Plastic Surgeons. "They had a choice until 1992," he says, when the FDA severely restricted silicone implant use, following concerns that ruptured or leaking implants could wreak havoc on internal organs. Various studies didn't find a connection between silicone gel implants and serious illness, though some experts think the implants are linked to symptoms similar to those of chronic fatigue syndrome. The FDA panel attached nine conditions for MemoryGel's approval, but said that overall it felt comfortable with Mentor's proof of the implants' safety. Opponents claim that silicone implants haven't yet been proven safe, and there's evidence that they're downright dangerous: Women who've received silicone implants say they've experienced a grisly list of side effects, including the aforementioned ooze. One 2004 study found high concentrations of platinum in women who had them, which impaired some patients' vision and hearing and gave them nervous tics. Still, silicone supporters point to their data and stick to the script: Women deserve a choice.

This appropriation of the word choice is interesting, since, after all, life is the big Bush administration buzzword, used to devastating effect by Republican leaders who want to mobilize socially conservative troops for a variety of causes. When Senate Majority Leader Bill Frist unexpectedly declared his support for stem cell research, for instance, White House spokesman Scott McClellan said, "The president does not believe that taxpayer money should be used to support the further destruction of human life." In the case of Terri Schiavo, the "right to die" was rewritten as the "right to life"—a deft edit that spurred on religious-right support for Schiavo's parents. Yet, for all the left-wing word association, choice is now working for corporate America: Mentor's advocates are portraying a controversial product as a tool of empowerment, aligning it with the idea that women should have a right to choose what they to do with, or to, their bodies.

But National Organization for Women president Kim Gandy claims that the issue is safety, not choice. Asserting that the silicone implants have not been adequately tested and likening them to "loaded weapons," she tells the Voice, "Women don't know the dangers of these implants. The fact is that abortion is a safe procedure, with relatively few complications. And the same is true, to a considerable degree, with saline implants [which are FDA-approved]. But that's not the case with silicone. We know they're dangerous." Doctors may unknowingly assure patients that the silicone implants are safe, she says, because of FDA approval. The culprit is "corporate greed," says Gandy. If the FDA approves MemoryGel, Mentor Corporation stands to make millions.

In a statement, Mentor's president and CEO Josh Levine called allegations against his company "old news," expressing his confidence that "this scientific process will not be complicated by old accusations from parties with agendas that go well beyond the safety and efficacy of these products." Dr. D'Amico, whose organization supports the silicone gel implants, disputes the idea that the use of choice was calculated. "This isn't a political or emotional issue, and we need to be careful of that," he says. "What we as plastic surgeons want to do is give women information and let them make choices. The scientific data speaks for itself."

The scientific evidence speaks for itself when it comes to Plan B, too. Now the FDA faces the irony of approving a breast implant touted for giving women a "choice" while they drag their feet on the highest profile "choice" issue out there.

That the FDA has not yet approved Plan B, which prevents pregnancy, for over-the-counter use comes as no shock in these Republican times, even though that agency declared the drug safe in 1997, making it available by prescription, and two advisory panels favored its approval for nonprescription status in 2003. (The FDA threw out that recommendation in May 2004.) Right-wing roaring against Plan B has been deafening, which is presumably why Governor Pataki, until now a pro-choice moderate, vetoed a bill on August 4 that would have enabled pharmacists to dispense emergency contraception (he claimed it was because minors would have unchecked access to the drug). Massachusetts GOP governor Mitt Romney vetoed a similar bill the week before.

Both men are rumored to be considering presidential bids in 2008.

 
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