Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
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.
A total of 163 subjects (~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.
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.
The Style 410 anatomically shaped, form-stable gel breast implants demonstrated long-term safety and effectiveness.
- Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
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- Available under Open Access This content is freely available online to anyone, anywhere at any time.
Aesthetic Plastic Surgery
Volume 33, Issue 3 , pp 430-436
- Cover Date
- Print ISSN
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- Quality of life
- Silicone breast implants
- Industry Sectors
- Author Affiliations
- 1. Akademikliniken, Stockholm, Sweden
- 2. Bronz Clinic, Lugano, Switzerland
- 3. Rigshospitalet, Copenhagen, Denmark
- 4. Bordet Institut, Tumor Centre of the Free University of Brussels, CHU St. Pierre, University of the Brussels, Brussels, Belgium
- 5. Allergan, Santa Barbara, CA, USA
- 6. Bay Imaging Consultants, San Francisco, CA, USA
- 7. Department of Plastic Surgery, Helsinki University Central Hospital, Helsinki, Finland
- 8. Kennemer Gasthuis Hospital, Haarlem, The Netherlands
- 9. Kliniek Klein Rosendael, Rozendaal, The Netherlands