Natrelle Silicone Breast Implant Follow-Up Study
| Autor: | George J. Picha, Diane K. Murphy, Navin K. Singh |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
medicine.medical_specialty Time Factors Breast Implants Mammaplasty medicine.medical_treatment Population Sodium Chloride Prosthesis Design Risk Assessment law.invention Silicone Gels Young Adult Randomized controlled trial law Implant Capsular Contracture medicine Humans education Breast Implantation Life Style Aged Demography education.field_of_study business.industry Middle Aged United States Prosthesis Failure Surgery Equipment Failure Analysis Cosmetic: Original Articles Treatment Outcome Breast implant Female Observational study Implant business Breast reconstruction Mastectomy Follow-Up Studies |
| Zdroj: | Plastic and Reconstructive Surgery |
| ISSN: | 0032-1052 |
| Popis: | Breast reconstruction is among the 10 most common reconstructive surgical procedures in the United States.1 The number of procedures has increased steadily since 2000, with nearly 100,000 procedures performed in 2013 alone.1 A primary, growing reason for breast reconstruction is to restore breasts to their presurgical form following mastectomy due to breast cancer.2–5 Breast reconstruction is also used to correct congenital deformities, malformations, and trauma to the breast.6,7 Natrelle silicone gel-filled breast implants (Allergan, Irvine, Calif.) are available in a range of implant options and are approved by the US Food and Drug Administration (US FDA) for primary reconstruction and revision-reconstruction as well as for primary augmentation and revision-augmentation.8 The Breast Implant Follow-up Study (BIFS-001) is a large, multicenter, 10-year observational study being conducted as part of a US FDA requirement to provide postapproval data on safety concerns associated with the use of silicone-filled breast implants. The primary objective of this study is to compare the long-term safety and effectiveness of Natrelle silicone breast implants with those of saline implants or national norms in subjects who underwent primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction. This ongoing study has enrolled more than 50,000 subjects. Although primary outcome data will continue to be collected over a 10-year period, available baseline data provide an opportunity to examine the demographic, health, lifestyle, and surgical characteristics of a large population of women requesting to undergo breast reconstruction. Because the analysis of safety endpoints in BIFS-001 will involve comparisons between silicone and saline implant groups that are self-selected rather than randomly assigned, it is especially important to understand how characteristics such as health and lifestyle factors that may potentially impact safety outcomes differ at baseline. The current analysis consequently describes demographic, health, lifestyle, and surgical characteristics for subjects enrolled in BIFS-001 who underwent either primary reconstruction or revision- reconstruction surgery and baseline rates for some of the important safety outcomes. An analysis of subjects who underwent either primary augmentation or revision-augmentation surgery is reported separately. This analysis aimed to assess how characteristics of women undergoing primary reconstruction procedures differ from those in the revision-reconstruction population and how women who select silicone implants differ at baseline from those who choose saline implants. Such differences may have important implications for the long-term safety profile of silicone implants in clinical practice. |
| Databáze: | OpenAIRE |
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