Sientra primary and revision augmentation rupture trending and analysis with magnetic resonance imaging.

BACKGROUND

Rupture of silicone gel breast implants is a rare occurrence but remains one of the key surgical concerns. The objective of this article was to provide visibility and information on trends for the impact that patient and surgical characteristics play in the occurrence of rupture.

OBJECTIVES

Examine trends in surgical techniques to better understand the etiology of implant rupture.

METHODS

Analysis was based on Sientra's prospective, open-label, U.S.-based clinical study of High-Strength Cohesive silicone breast implants. Patient and surgical characteristics were compared between ruptured and intact implants.

RESULTS

The subset of data used for this analysis included 1792 implants in 935 primary and revision augmentation patients implanted by 31 plastic surgeons, with an average follow-up of 6.6 years. The results confirm that rupture remains a rare adverse event. Overall, the rupture prevalence for this study was 2.4%. Rupture prevalence was lower among textured devices (0.8%) compared to smooth devices (3.8%). The prevalence of rupture was 7.8% among devices placed with a transaxillary incision site compared to 1.6% and 3.0% when placed with an inframammary or periareolar incision site, respectively. Rupture was reported in 5.5% of the devices that received steroid pocket irrigation, compared to 1.8% of the devices that did not.

CONCLUSIONS

Although ruptures in the Sientra study with the High-Strength Cohesive silicone gel implants were an uncommon occurrence, the authors were able to identify strong trends for the association of certain surgical factors and characteristics. The results show among other factors that an inframammary approach and a textured device were found to be protective against rupture.

LEVEL OF EVIDENCE

2 Therapeutic.