In reaching the decision, the FDA considered the risks and benefits of silicone implants," Dr. Donna Bea-Tillman, FDA's director of the Office of Device Evaluation, said during the news conference.God (as interpreted by Micah (and Larry)):
"Although there were a number of complications reported in the core studies, including breast hardening, breast pain, breast implant rupture, and the need for additional surgery, most of the women in the core studies reported being satisfied with their results," she said.
In addition, the FDA looked at a report by the Institute of Medicine, which found no cases of connective tissue disease or cancer associated with silicon implants, Bea-Tillman said.
The watchdog group Public Citizen has opposed the use of silicone gel breast implants since the fall of 1988.
Preachers Larry Keffer and Micah Armstrong, of the Biblical Research Center, protested outside of the strip club Saturday night. Redner said the group has protested in the past, but Saturday’s event was the most disruptive, including a megaphone.This appears to be one issue on which Public Citizen and the Biblical Research Center are in agreement.
The group was yelling at patrons as the entered and exited the building, shouting at patrons. “God is not impressed with the size of your breasts! God is not impressed with your talent!” yelled one of the protesters.
Virginia Postrel had this to say in 1996:
Right now, breast implants symbolize the power politics of the Food and Drug Administration and the breakdown of the tort system. This is a nice, comfortable significance that even Washington understands, one that generates money for think tanks working on legal reform. It makes a terrific Fortune cover story. And it is, indeed, worth pointing out.The Postrel link comes via A Second Hand Conjecture.
There never was any credible evidence linking implants to major diseases. Yet juries made multimillion-dollar awards to women claiming they'd gotten sick from their implants, and the FDA imposed a moratorium on most sales. (Post hoc ergo propter hoc is the first fallacy they teach in logic, but just try getting on a jury if you've ever studied logic.) Now we have good evidence that implants don't cause the maladies for which they've been blamed. And the exculpatory studies keep coming; two new ones were presented at the annual meeting of the American College of Rheumatology.
On October 22, that group issued an official statement declaring that "studies provide compelling evidence that silicone implants expose patients to no demonstrable additional risk for connective tissue or rheumatic disease. Anecdotal evidence should no longer be used to support this relationship in the courts or by the FDA." But neither juries nor the FDA are listening to the experts.
Exactly one week later, in fact, a jury in Nevada awarded $4.1 million to a woman who claimed she'd gotten immune-system and neurological diseases from her implants. The defendant, Dow Chemical, hadn't even made the implants; it had just done general studies on silicone for Dow Corning, a joint venture with Corning Glass Works. It's as though the Simpson jury had convicted Kato Kaelin, Rosa Lopez, and that famous barking dog. Proximity was more important than proof.
Meanwhile, the war on implants is causing collateral damage. Silicone itself has become a casualty. Science suggests it's a benign, useful substance, vital to all sorts of medical products. Jury awards say otherwise. So products that use siliconefrom brain-fluid shunts to artificial joints are in trouble. Supplies are drying up, going only to wealthy manufacturers that agree to assume the risk of future litigation. And even they pay dearly; prices have risen as much as 700 percent.