When science speaks, we should all listen. And nowhere is this more important than when it relates to the public health. When the best science is allowed to drive decisions about healthcare, we all win. That’s true when the decision is a regulatory one, and doubly so when it’s on a highly public issue like silicone breast implants. Sound science results in sound decision-making. When science is replaced by rhetoric, all bets are off.

“The FDA, sponsors, and the clinical community have learned a great deal about breast implants, especially silicone gel-filled breast implants, over the last 10 years,” said Mark B. McClellan, M.D. Ph.D., the former Commissioner of Food and Drugs. And there’s a great deal to have been learned. Over the past decade advances in silicone breast implant technology has been remarkable. Implants today are tested to withstand 850 pounds of force. As a relevant point of reference, a normal mammogram creates about 32 pounds of force.

But what’s more important is what science has found out about the safety of silicone. The prestigious Institute of Medicine (a private, nonprofit organization that provides health policy advice under a congressional charter granted to the National Academy of Sciences), in a well-documented, thoughtful exploration of the safety of these silicone breast implants, laid down the scientific marker that patients, doctors, and the regulatory community must now consider in any future actions. Recent epidemiological studies, as well as voluminous data on the chemicals used in implants, led the IOM to several key conclusions:

• There is no evidence to suggest that the silicones used in implants are toxic to humans. When individual studies have pointed to possible toxic, immunological, or neurological effects, more extensive analyses failed to uncover associations with specific diseases or conditions.
  
• There is no established link between implants and a unique disease syndrome. Syndromes of the type ascribed to implants generally involve symptoms that are nonspecific and common in the general population.
  
• There is no evidence that conclusively links silicone to harmful effects on the immune system. Early studies addressing the immunology of silicones are limited and have substantial technical problems. Follow-up analyses have failed to uncover associations with specific immunological diseases or other conditions.

The IOM also concluded that there is no evidence that mothers with implants pass silicone on to infants when breast-feeding. Much higher levels of silicon -- the element on which the silicone family of organic compounds is based -- have been found in cows' milk and commercially available infant formula than in the milk of nursing mothers with implants. Because of the many health benefits of breast milk to infants, the committee recommended that all mothers with implants attempt to breast-feed their infants.

In short, silicone breast implants are safe.

As FDA considers whether or not to allow silicone breast implants back on the market, it’s imperative that their decision be based on sound science rather than influenced by loud rhetoric. In announcing FDA’s new guidance on silicone breast implants, then Commissioner, Dr. Mark McClellan, pointed to science as the only way to move forward responsibly, “We believe the proposed guidance document will provide a clear, scientifically appropriate, and up-to-date pathway for sponsors seeking to demonstrate reasonable assurance of the safety and effectiveness of their products.”

When science rules the patient wins.