Wednesday was a busy day for the Food & Drug Administration (FDA), what with the agency continuing to stonewall the upgrading of "morning after" pill RU-486 to over-the-counter status, and the release of a report by health regulators which estimated that up to 93 percent of silicone breast implants ruptured within 10 years.
Of course, no one currently working in the adult video industry has silicone implants, which were banned for elective surgical use 13 years ago – they can still be used for reconstructive surgery – and which have drawn fire for more than 20 years from women who claimed that ruptured and leaking implants caused a multitude of conditions from multiple sclerosis to neuritis and other connective tissue diseases. Lawsuits by claimants bankrupted Dow Corning, a large maker of implants.
But in 1999, a panel of scientists found that most of the implanted women's complaints could not be traced to the silicone in the sacs, but rather that the primary faults connected to the implants were local complications like bacterial infections, pain and internal scarring around the implant sites.
The question of what problems can actually be traced to the silicone is in the news again, with several manufacturers of the implants petitioning the FDA to declare the implants safe for use. On Monday, a committee of plastic surgeons and other experts will hear testimony from implant "victims" and review studies done over the past several years, and make a recommendation to the agency by April 13 as to whether to lift the ban.
Making the recommendation even more problematic is the fact that women with silicone implants often don't know whether the sacs have ruptured, in contrast to those with saline implants – the kind used by today's porn stars and dancers – which deflate immediately when leaks develop. Hence, the actual number of siliconed women whose implants have failed is largely a guesstimate.
But even when that report gets done, there may be no one to whom to present it. President Bush's nominee to become the new head of the FDA is being blocked from Senate confirmation by Democrats Hillary Rodham Clinton (N.Y.) and Patty Murray (Wash.), who said Wednesday that they would hold up a vote until the agency settled the long-delayed question of whether emergency contraceptive RU-486 could be sold over the counter.
The nominee, Dr. Lester M. Crawford, a veterinarian by training, has been criticized, since his appointment as acting commissioner 18 months ago, for his conservative views on abortion. He was also the subject of a massive petition drive last year calling for his removal after he refused to certify RU-486 for over-the-counter sales, even though two panels of researchers had cleared it as safe for non-prescription use.
The FDA had said that it would act by January on a petition by Barr Laboratories to market the pill, known as "Plan B," to women 16 years or older, but that decision has been delayed several times. Asked at a hearing last month as to when the new decision would be issued, he said, "I wouldn't want to say days. I would say weeks." But he said he could not guarantee a decision before April 13, when the committee is expected to vote on his nomination. That response wasn't good enough for the two senators.
"I'm prepared to hold it for as long as it takes to get a decision made," Mrs. Clinton said. She added, "From everything we're able to determine, the agency has substituted politics and ideology for science and facts."
