Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.
BACKGROUND
In 2006, a single-center Swedish study demonstrated a low rupture rate and high patient satisfaction with the Style 410 shaped, form-stable gel implant. The current study aimed to validate the accuracy of the previously published results across multiple European sites.


METHODS
A total of 163 subjects (approximately 70% had augmentation [n = 112], 15% had reconstruction [n = 25], and 15% had revision [n = 26]) underwent a physical examination followed by breast magnetic resonance imaging (MRI) for rupture detection. These subjects had been implanted for 5 to 11 years with at least one Style 410 shaped gel breast implant before examination. The secondary end points included lactation, reproductive and breast disease history before and after implantation, and quality-of-life measurements and complications after implantation.


RESULTS
The implant rupture rate was 1.7% a median of 8 years after implantation. Capsular contracture was the most common complication noted at the physical examination, occurring for 5.3% of implants, and there were no cases of grade 4 capsular contracture. The postimplantation rates for lactation and reproductive problems and breast disease were lower than the preimplantation rates. Breast implantation surgery was considered advantageous by 91% of the subjects, demonstrating high patient satisfaction.


CONCLUSIONS
The Style 410 anatomically shaped, form-stable gel breast implants demonstrated long-term safety and effectiveness.
Akademikliniken, Stockholm, Sweden. per.heden@ak.se
Per
P
Hedén
Giorgio
G
Bronz
Jens Jorgen
JJ
Elberg
Rika
R
Deraemaecker
Diane K
DK
Murphy
Araceli
A
Slicton
R James
RJ
Brenner
Catarina
C
Svarvar
Joost
J
van Tetering
Leo Peter
LP
van der Weij
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019928:Breast Implantation; D018427:Breast Implants; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D017060:Patient Satisfaction; D011474:Prosthesis Design; D011788:Quality of Life; D012086:Reoperation