TY - CHAP
T1 - Cohesive breast implants
T2 - A significant difference?
AU - Cunningham, Bruce L
PY - 2008/12/1
Y1 - 2008/12/1
N2 - It may seem quite surprising to most of the plastic surgeons around the world that the Americans are the last to be able to use silicone gel implants without significant restrictions being placed on them. The FDA Advisory Panel recommended approval of the devices in the spring of 2005, and the Agency issued Approvable letters in the summer of the same year to the two domestic manufacturers of the devices. Despite this scientific foundation for these devices, they were not finally approved until November of 2006. The round devices have not been approved, and it is felt that the shaped devices, currently so popular in Europe, will not be evaluated for at least a year after final approval of the round devices.
AB - It may seem quite surprising to most of the plastic surgeons around the world that the Americans are the last to be able to use silicone gel implants without significant restrictions being placed on them. The FDA Advisory Panel recommended approval of the devices in the spring of 2005, and the Agency issued Approvable letters in the summer of the same year to the two domestic manufacturers of the devices. Despite this scientific foundation for these devices, they were not finally approved until November of 2006. The round devices have not been approved, and it is felt that the shaped devices, currently so popular in Europe, will not be evaluated for at least a year after final approval of the round devices.
UR - http://www.scopus.com/inward/record.url?scp=84895202368&partnerID=8YFLogxK
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U2 - 10.1007/978-3-540-46326-9_51
DO - 10.1007/978-3-540-46326-9_51
M3 - Chapter
AN - SCOPUS:84895202368
SN - 9783540463214
SP - 414
EP - 416
BT - Innovations in Plastic and Aesthetic Surgery
PB - Springer Berlin Heidelberg
ER -