Before a transcript of the press conference was available, we compiled quotes from media coverage of FDA's explanation of their decision not to approve silicone gel breast implants, and the reasons they are requesting better safety data.

"This is based on the science, and the science is not perfect. It evolves," Feigal said, Dow Jones News Service, 1/8.

The FDA's Feigal said advances in science raised new questions that researchers now should be able to answer. Among the requirements are settling whether women whose implants leak silicone without symptoms need them removed; doing mechanical testing to predict how long implants will last before rupturing; and performing more detailed exams of what happens when silicone leaks beyond the breast. Associated Press, 1/8.

"These are things ... we need to know so that consumers can make an informed choice and so the surgeons know what to do for that subset of patients that have problems," said the FDA's medical device chief, Dr. David Feigal. Associated Press, 1/8.

"It's important that the people who use these products know how they will perform," said Dr. David Feigal. "Women who have complications from these types of products should understand what they can expect." Boston Globe, 1/9.

A major unanswered question is whether implants should be removed in cases of "silent" ruptures that do not cause symptoms but can be detected by MRI scans, Feigal said. Reuters, 1/8.

Patients who want implants and the doctors who perform the surgery need information on ruptures to "understand how to treat them and what the consequences of those problems are," Feigal said. Dow Jones News Service, 1/8.

"We see this as making things clearer," [Dr. Daniel Schultz, who heads the office of device evaluation in the Center for Devices and Radiological Health] said during the conference call. He pointed out that no medical product or procedure is 100% safe. "The best way to get to approval is to provide sufficient data," he said. Dow Jones News Service, 1/8.

"We need to know when it (leaking or rupture) happens, we need to know why it happens and ultimately we need to know what the consequences are," said Dr. Dan Schultz. "What we want is a picture of the device over the performance of its lifetime." Baltimore Sun, 1/9.

"One of the goals is to decrease the rupture rate but also to understand the consequences of rupture," David Feigal, the FDA's medical-device chief, said at a news conference. Philadelphia Inquirer, 1/9.

"We have emphasized the need to better understand the consequences of rupture and the effects of rupture," said David Feigal. "That's something that both surgeons and women need to know." Wall Street Journal, 1/12.

"There's additional information that we think is necessary for this product to pass the threshold of what we consider necessary for open marketing," said Daniel Schultz. USA Today, 1/9.

"We need to know how often complications occur, the costs of repeated surgeries, and what women should plan for with this foreign body in their body," said radiologist Emily Conant, director of breast imaging at the University of Pennsylvania Medical Center [and member of the FDA's advisory panel]. "This is an important issue. It's very political, it involves a lot of money, a lot of lobbying, and it's not simple. But I think the FDA did the right thing for now." Philadelphia Inquirer, 1/9.

Dr. Michael Choti, an associate professor of surgery and oncology at Johns Hopkins Hospital, was among the advisory panel members who opposed approving the silicone implants for widespread use. He had concerns, he said, not just about the potential problems they might cause in the breast area but throughout the body. "We don't really know the long-term effects of having these devices in women, particularly when they rupture or leak," he said. "A woman needs to be able to choose an implant if she wants it. The problem is, in order to have informed consent and to be able to choose, a woman needs to know what are the risks of putting these in the body." Baltimore Sun, 1/9.

"We don't have evidence of the long-term effects, both local and systemic, of leaked silicone," said Michael A. Choti, a professor at Johns Hopkins University and one of the six members on the 15-person FDA advisory committee who voted against Inamed. The FDA's new requirements are "appropriate," he said. Wall Street Journal, 1/12.

"With its request for much more information before deciding whether to let silicone gel breast implants go back on the market, the U.S. Food and Drug Administration has shown surprising and welcome caution. Silicone-gel proponents point to studies that show no big health risk; they say the science is settled. But, in fact, almost no science exists on the effects when an implant ruptures or leaks, letting the gel loose inside the body. FDA summaries on implants put it bluntly: 'The relationship of free silicone to development or progression of disease is unknown,'" Detroit Free Press Editorial, 1/10.