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.
- Hedén P, Boné B, Murphy DK, Slicton A, Walker PS (2006) Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation. Plast Reconstr Surg 118:1281–1287 CrossRef
- Danino AM, Basmacioglu P, Saito S, Rocher F, Blanchet-Bardon C, Revol M, Servant J (2001) Comparison of the capsular response to the Biocell RTV and Mentor 1600 Siltex breast implant surface texturing: a scanning electron microscopic study. Plast Reconstr Surg 108:2047–2052 CrossRef
- Hölmich LR, Fryzek JP, Kjøller K, Breiting VB, Jørgensen A, Krag C, McLaughlin JK (2005) The diagnosis of silicone breast-implant rupture: clinical findings compared with findings at magnetic resonance imaging. Ann Plast Surg 54:583–589 CrossRef
- Herborn CU, Marincek B, Erfmann D, Meuli-Simmen C, Wedler V, Bode-Lesniewska B, Kubik-Huch RA (2002) Breast augmentation and reconstructive surgery: MR imaging of implant rupture and malignancy. Eur Radiol 12:2198–2206
- Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell GP (2007) Style 410 highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg 120(Suppl 1):40S–48S CrossRef
- (2008) Natrelle silicone-filled breast implants (package insert, Canada). Allergan Inc., Santa Barbara, CA
- Brown MH, Shenker R, Silver SA (2005) Cohesive silicone gel breast implants in aesthetic and reconstructive breast surgery. Plast Reconstr Surg 116:768–779 CrossRef
- Graf RM, Bernardes A, Rippel R, Araujo LR, Damasio RC, Auersvald A (2003) Subfascial breast implant: a new procedure. Plast Reconstr Surg 111:904–908 CrossRef
- Serra-Renom J, Garrido MF, Yoon T (2005) Augmentation mammaplasty with anatomic soft, cohesive silicone implant using the transaxillary approach at a subfascial level with endoscopic assistance. Plast Reconstr Surg 116:640–645 CrossRef
- Bronz G (2002) A comparison of naturally shaped and round implants. Aesthet Surg J 22:238–246 CrossRef
- Cash TF, Duel LA, Perkins LL (2002) Women’s psychosocial outcomes of breast augmentation with silicone gel-filled implants: a 2-year prospective study. Plast Reconstr Surg 109:2112–2121 CrossRef
- Banbury J, Yetman R, Lucas A et al (2004) Prospective analysis of the outcome of subpectoral breast augmentation: sensory changes, muscle function, and body image. Plast Reconstr Surg 113:701–707 CrossRef
- Long-Term Safety and Effectiveness of Style 410 Highly Cohesive Silicone Breast Implants
- Open Access
- 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
- Online ISSN
- Additional Links
- 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