Silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants.

Concern has been expressed over the long-term integrity of silicone gel breast implants. There are no large series representing experience with these implants outside of the United States. A retrospective case note review of explanted silicone breast implants was performed; 478 implants have been explanted during the past 11 years and relate to the use of these devices since 1971. Loss of implant integrity was not simply related to its age in vivo. Failure was more likely with implants of the late 1970s and early 1980s (second generation) and with subpectoral placement. Implant failure was independent of capsular contracture as the indication for removal (p = 0.09). There is no evidence that the currently used textured silicone gel breast implants are subject to the same loss of integrity as previous examples of these devices. The life span of these implants, the first of which are approaching 10 years in vivo, is at present unknown. Information concerning the integrity of silicone gel breast implants is essential in the current climate for counseling of both new and old implant recipients.