MemoryShape: impact of clinical trials, global medical economics, and the future.

ABSTRACT

The global breast implant business was invented and configured by American plastic surgeons. In 2012, the first shaped silicone implants were approved in the United States by the Food and Drug Administration. It is the peculiar historical course of implant usage in America that has deprived US plastic surgeons of the opportunity to become experts in the use of this device. Most studies indicate significant safety benefits to using shaped devices, despite the technical challenges involved in their use. Upon approval, adoption of the devices has been slow in the United States, running the risk that American plastic surgery may lose the intellectual and clinical practice hegemony it has enjoyed for over 50 years in this area of the specialty. To continue to maintain leadership in the field of breast surgery, US surgeons should evaluate this new modality and either join the global trend or present data to contradict it.