Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation.
BACKGROUND
Inamed introduced a fourth-generation implant, the Style 410 cohesive silicone breast implant, in 1993. To date, little has been published on this implant despite its widespread use in Europe, and no data are available on its long-term rupture rate.


METHODS
Women implanted with Style 410 implants between 1995 and 1999 at Akademikliniken Hospital in Stockholm were eligible to participate in the study. One hundred forty-four of 302 potential subjects received a physical examination, underwent magnetic resonance imaging screening for silent rupture, and completed a quality-of-life survey. The majority of subjects were Caucasian (96 percent), with a median age of 39 years. The study population consisted of subjects with cosmetic augmentation (86 percent) or revision of previous breast implantation (14 percent). Median time elapsed between physical examination and magnetic resonance imaging was 2 days.


RESULTS
The 144 subjects provided 286 implants for magnetic resonance imaging assessment, with a median implantation time of 6 years (range, 5 to 9 years). Overall, 99.0 percent of implants showed no evidence of rupture, 0.3 percent showed evidence of rupture, and 0.7 percent were indeterminate. The most common complication noted at physical examination was capsular contracture (5.6 percent). All other complications occurred in less than 3 percent of subjects. Quality-of-life results found an improvement in overall sense of well-being for 87 percent of subjects. Most compelling is that 97 percent stated an overall feeling that their breast implantation had been advantageous.


CONCLUSIONS
The authors' findings support the long-term safety and effectiveness of Inamed Style 410 cohesive breast implants and demonstrate a low prevalence of rupture.
Hedén
Per
P
Stockholm, Sweden, and Santa Barbara, Calif. From the Department of Plastic Surgery, Akademikliniken Hospital; Department of Radiology, Karolinska University Hospital; and Inamed Corporation.
Boné
Beate
B
Murphy
Diane K
DK
Slicton
Araceli
A
Walker
Patricia S
PS
D000328:Adult; D019928:Breast Implantation / Q000009:adverse effects; D018427:Breast Implants / Q000009:adverse effects; D019544:Equipment Failure Analysis / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D016462:Mammaplasty / Q000379:methods; D010173:Palpation; D011474:Prosthesis Design; D011788:Quality of Life; D012086:Reoperation; D012449:Safety; D020034:Silicone Gels; D011795:Surveys and Questionnaires; D013548:Sweden; D013997:Time Factors
D020034:Silicone Gels