A new follow-up study has reaffirmed the safety of Sientra’s Silimed brand silicone gel implants, which were approved in March by the FDA. Among the results of the study, which appears in the most recent issue of Plastic & Reconstructive Surgery, was a 99 percent rate of satisfaction among surgeons with the postoperative results.
The Sientra implants became the third FDA-approved silicone gel-filled breast implant in the United States when they were approved in March, joining implants manufactured by Allergan and Mentor. As one of the conditions of the approval, the FDA required Sientra to conduct post-approval studies. These would assess long-term safety and effectiveness outcomes, as well as the risks of rare complications.
The original approval for Sientra’s implants followed the largest silicone gel breast implant study to date. It made history for being the first approval for shaped silicone gel breast implants, which have been used worldwide, most notably in Brazil. This latest study presents the results of Sientra’s ongoing study through 5 years.
There are 1,788 women participating in the study, who were altogether implanted with 3,506 implants. These included:
- 1116 primary augmentations
- 363 revision-augmentations
- 225 primary reconstructions
- 84 revision-reconstruction subjects
During their follow-up appointments, the participants have physical evaluations, and complications are recorded at each visit. The effectiveness of the implants was measured by bra cup size, as well as ongoing assessments of subject satisfaction and quality of life.
What are the results after five years?
Overall, the risks involved with the Sientra implants are comparable to the implants already manufactured by Allergan and Mentor:
- rupture: 1.8%
- contracture: 9%
- reoperation: 23.8%
The authors show that over 99 percent of surgeons reported satisfaction with the postoperative results. As well, subject satisfaction remained high, even five years after their surgeries. As a result, the authors argue, the five-year results “continue to provide a comprehensive safety and effectiveness profile.”