Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. food and drug administration-approved silimed® brand round and shaped implants with high-strength silicone gel

Plastic and Reconstructive Surgery

Volumn 130, Issue 5, 2012, Pages 973-981

  Stevens, W Grant ^a,c   Harrington, Jennifer ^c   Alizadeh, Kaveh ^c   Berger, Lewis ^c   Broadway, David ^c   Hester, T Roderick ^c   Kress, Donald ^c   D'Incelli, Rosalyn ^b,c   Kuhne, JoAnn ^c   Beckstrand, Maggi ^c  

^a Marina Plastic Surgery Associates   (United States)

^b Sientra   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BREAST AUGMENTATION; BREAST IMPLANT; CLINICAL TRIAL; DEVICE APPROVAL; FOLLOW UP; HUMAN; IMPLANT CAPSULAR CONTRACTURE; MULTICENTER STUDY; PATIENT SATISFACTION; PROSTHESIS; PROSTHESIS FAILURE; QUALITY OF LIFE; REOPERATION; RUPTURE;

BREAST IMPLANTATION; BREAST IMPLANTS; DEVICE APPROVAL; FOLLOW-UP STUDIES; HUMANS; IMPLANT CAPSULAR CONTRACTURE; PATIENT SATISFACTION; PROSTHESIS DESIGN; PROSTHESIS FAILURE; QUALITY OF LIFE; REOPERATION; RUPTURE;

EID: 84871755045     PISSN: 00321052     EISSN: None     Source Type: Journal    
DOI: 10.1097/PRS.0b013e31826b7d2f     Document Type: Article

References (21)

1. Barr S, Hill E, Bayat A. Current implant surface technology: An examination of their nanostructure and their influence on fibroblast alignment and biocompatibility. Eplasty 2009; 9:e22. Available at: http://www.ncbi.nlm. nih.gov/pmc/articles/PMC2698670/. Accessed July 9, 2012.
2. Sientra, Inc. Summary of safety and effectiveness data (SSED). Santa Barbara, Calif: Sientra; 2012.
3. Lin KY, Blechman AB, Brenin DR. Implant-based, two-stage breast reconstruction in the setting of radiation injury: An outcome study. Plast Reconstr Surg. 2012;129:817-823.
4. Sientra, Inc. Directions for use, Sientra silicone gel breast implants. Santa Barbara, Calif: Sientra; 2012.
5. Deapen D. Breast implants and breast cancer: A review of incidence, detection, mortality, and survival. Plast Reconstr Surg. 2007;120:70S-80S.
6. Brinton LA. The relationship of silicone breast implants and cancer at other sites. Plast Reconstr Surg. 2007;120:94S-102S.
7. Independent Review Group. Silicone gel breast implants: The report of the Independent Review Group. Cambridge, UK: Jill Rogers Associates; July 1998.
8. Cunningham B. The Mentor Core Study on Silicone Memory-Gel Breast Implants. Plast Reconstr Surg. 2007;120(Suppl 1):19S-29S; discussion 30S-32S.
9. Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007; 120(Suppl 1):8S-16S; discussion 17S-18S.
10. Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell GP; Style 410 U.S. Core Clinical Study Group. Style 410 highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg. 2007;120(Suppl 1):40S-48S.
11. Hammond DC, Miglori MM, Caplin DA, Garcia ME, Phillips CA. Mentor Contour Profile Gel implants: Clinical outcomes at 6 years. Plast Reconstr Surg. 2012;129:1381-1391.
12. Cunningham B, McCue J. Safety and effectiveness of Mentor's MemoryGel implants at 6 years. Aesthetic Plast Surg. 2009;33:440-444.
13. Mentor Medical Systems BV. Package insert: MemoryGel silicone gel-filled breast implants, Health Canada, 2008. Available at: http://www.hc-sc.gc.ca/dhp- mps/prodpharma/sbd-smd/md-im/pi-np-2008-lowbleed-69312-eng.php. Accessed June 24, 2012.
14. Allergan, Inc. Directions for use, INAMED silicone-filled breast implants smooth & BIOCELL texture. Santa Barbara, Calif: Allergan; 2006. Revision dated November 3, 2006.
15. Wong CH, Samuel M, Tan BK, Song C. Capsular contracture in subglandular breast augmentation with textured versus smooth breast implants: A systematic review. Plast Reconstr Surg. 2006;118:1224-1236.
16. de Jong D, Vasmel WL, de Boer JP, et al. Anaplastic large-cell lymphoma in women with breast implants. JAMA 2008;300: 2030-2035.
17. U.S. Food and Drug Administration: Center for Devices and Radiological Health. Anaplastic large cell lymphoma (ALCL) in women with breast implants: Preliminary FDA findings and analyses. January 2011. Available at: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/BreastImplants/UCM240003.pdf. Accessed July 3, 2012.
18. Breiting VB, Hölmich LR, Brandt B, et al. Long-term health status of Danish women with silicone breast implants. Plast Reconstr Surg. 2004;114:217-226; discussion 227-228.
19. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342: 781-790.
20. World Health Organization: International Agency for Research on Cancer. Surgical implants and other foreign bodies: Summary of data reported and evaluation. IARC Monogr Eval Carcinog Risks Hum. 1999;74:1-8.
21. National Institutes of Health. Breast implants: Status of Research at the National Institutes of Health. Bethesda, Md: National Institutes of Health; 2005.