I’m pleased to report to our readers that there is now a third FDA approved line of silicone implants available for cosmetic and reconstructive surgery patients in the USA.
Sientra achieved FDA approval for silicone implants in March 2012. The company has an intriguing track record of implant production in non-US markets for over 2 decades. The Sientra brand was founded to market these products in the US.
What differentiates the new line of silicone implants is the availability of a SHAPED and TEXTURED gel implant. To date, a similar silicone gel implant has not been available in the US. There is a line of shaped, textured saline implants produced by Mentor, but the disadvantages of saline implants make this a less popular choice.
I’ve seen the new Sientra shaped implants – and they are intriguing. They would impart a more natural volume distribution within the breast than our current smooth, round silicone implants. In my opinion, a truly ‘natural’ augmentation result is characterized by a minimal amount of upper pole roundness – a giveaway for a ‘fake’ breast look. The Sientra implants impart more volume into the lower breast pole and less in the upper pole.
Issues that I can see with these shaped implants – displacement and malposition. The shaped implants can rotate in place, and alter the overlying breast shape. Despite the texturization, this rotation is possible if the pocket for the implant is made too big. Solution ? Careful sizing and pocket creation under direct vision by an experienced surgeon.
This brings me to the next interesting thing about the new implant line: at this time, they are only available for use by BOARD CERTIFIED plastic surgeons. All other surgeons can’t get them. Dentists, oral surgeons, cosmetic surgeons are out of luck. This is great – the other two implant companies market their devices to all-comers. Sientra will actually void the warranty of an implant placed by a non ABPS surgeon.
I’ll review the available data on implant failure, capsular contracture and other implant-related issues and compare this info with the two other companies’ devices and present a new post in a couple of weeks.
Until then, Happy Surgery !
Scott Sattler MD FACS is a board certified plastic surgeon in the Seattle area.