They are prone to rupture, however, and CDRH Director Daniel Schultz advises potential users to keep that in mind. Upfront disclosure of potential issues, continued disallowal of their use for cosmetic reasons for women under 22, and mandated postmarket studies by manufacturers Allergan and Mentor should be enough to assure that the implants are used as safely and effectively as possible. Consumers should remain vigilant, however, and FDA has given them a head start by providing a list of useful information about the Allergan and Mentor products. Part of FDA's job is to keep patently unsafe products off the market. But that does not extend to banning any product that might present some risks, as there is no such thing as a zero-risk medical device. As long as the science shows that silicone implants are not patently unsafe, and that research will continue to occur, it's best to let consumers decide for themselves.
