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Sientra safety data

Article-Sientra safety data

A new study looking at nine years of follow-up data on the use of Sientra’s HSC and HSC+ silicone gel breast implants helps to confirm implant safety profile and continued patient satisfaction.1

These round and shaped implants were FDA approved in March 2012. Researchers conducted the Core Study, which is an ongoing 10-year study, with 1,788 patients (3,506 Sientra implants) who had breast surgery for primary augmentation, revision-augmentation, primary reconstruction and revision-reconstruction. Researchers evaluated postoperative complications, including adverse effects from the implants. They also studied patient satisfaction scores on even years.

They found that the overall capsular contracture risk through nine years was 12.6%, with the smooth devices having higher capsular contracture rates than textured implants. There were 610 reoperations in 477 patients, with 51.6 % of those being for cosmetic reasons. According to the abstract, 90% of the primary augmentation patients reported they were satisfied with the implants’ natural and soft feel.

Commenting on the study Cosmetic Surgery Times advisor plastic surgeon Jason N. Pozner, M.D., of Boca Raton, Fla., says this newest study helps to confirm silicone gel implants’ safety. Sientra implants, he says, are as safe as the silicone gel implants from Mentor and Allergan.

“I think they’re all very similar,” Dr. Pozner says.

Related: Rethinking breast augmentation

A study published in 2015 on contoured cohesive gel breast implants assessed a single surgeon's outcomes in breast augmentation, secondary augmentation and breast reconstruction using implants from Allergan, Mentor and Sientra over a 10-year period. The author’s findings, which included 695 patients, suggest an overall low complication rate and high patient and surgeon satisfaction. While the total complication rate was lowest for primary augmentation of the Mentor group, versus the Allergan and Sientra groups, there were no notable differences in complication rates when the implants were used for secondary augmentation and reconstruction. There also were no statistically significant differences among the implant groups regarding reoperation, explantation or capsular contracture rates.2

While Dr. Pozner says he used to use Sientra’s implants, he now uses Allergan’s breast implants because Allergan allows physicians to tie in and save on their purchasing of the implants with Botox and fillers.

The only finding in this study that seems different than other silicone gel breast implant studies, according to Dr. Pozner, is the others did not show as significant a difference between smooth and textured implants in capsular contracture rates.


Dr. Pozner reports no relevant disclosures.

Among the authors on the study is the vice president of clinical operations, Sientra, based in Santa Barbara, Calif.


  1. Stevens WG, Calobrace MB, Harrington J, et al. Nine-year core study data for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel. Aesthet Surg J. 2016 Apr;36(4):404-16.
  2. Doren EL, Pierpont YN, Shivers SC, Berger LH. Comparison of Allergan, Mentor, and Sientra contoured cohesive gel breast implants: A single surgeon's 10-year experience. Plast Reconstr Surg. 2015 Nov;136(5):957-66.
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