In March of 2012, Sientra became the first of the three manufacturers to receive FDA approval for the sale of their version of the newest generation of shaped form stable breast implants. For the last 12 years, the only way a woman could obtain these devices in the United States was if she was willing to participate in a long-term clinical trial that studied the safety and effectiveness of these implants. As board certified plastic surgeons begin to offer their patients more options in breast augmentation and reconstruction, there will be more choices, but this may also lead to more confusion.
Since 2000, the only way women in America could get the newest version of highly cohesive gel breast implants, was if she was willing to enroll in a long term clinical trial. Three manufacturers, Allergan, Mentor, and Sientra have been working closely with the FDA, proving data on the safety and efficacy of the newest generation of shaped breast implants. Thousands of women have received these implants for breast augmentation, breast reconstruction, and the revision of problem breast implants. Dr. Glicksman and several other experienced investigators discuss the newest highly cohesive silicone gel breast implants.