![]() ![]() Frank Duteille, Michek Rouif, Sophie Laurent, et al.Sientra Shaped and Round Cohesive Gel Implants. Plast Reconstr Surg. 2018 Apr 141(4S): ):7S-19S. Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel. 12 Steven WG, Calobrace MB, Alizadeh KR, Harrington JL, d’Incelli RC.Date (SSED): Date of FDA Notice of Approval: March 9, 2012. Sientra, Inc. Silicone Gel-Filled Breast Implants Premarket Approval Application (PMA) Number P070004: FDA Summary of Safety and Effectiveness Data.Mentor® Memory GelTM Breast Implants and Mentor® MemoryGelTM Xtra Round Breast Implant, Product Insert Data Sheet.Date of FDA Notice of Approval: November 17, 2006. Mentor Corporation. SiliconeMemoryGel TMSilicone Gel- Filled Breast Implants, Premarket Approval Application (PMA) Number P030053: FDA Summary of Safety and Effectiveness Data (SSED).Anigian. Ideal Implant Structured Breast Implants: Core Study Results at 6 Years. Date of FDA Notice of Approval:November 14, 2014. Saline-filled Breast Implant. Premarket Approval Application (PMA) Number: P120011FDA Summary of Safety and Effectiveness Data (SSED). Jewell.A Comparison of Outcomes Involving Highly Cohesive, Form-Stable Breast Implants From Two Manufacturers in Patients Undergoing Primary Breast Augmentation. Natrelle Silicone Breast Implant Follow-up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 5000 Reconstruction Subjects. Plast Reconstr Surg Glob Open 2015 3:e489 Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study. Style 410 Highly Cohesive Silicone Breast Implant Core Study Results at 3 Years. Plast. Approval for Inspira Cohesive Silicone-Filled Breast implant Filled with Highly-Cohesive Silicone Gel. Date of FDA Notice of Approval February 20, 2013. Gel-Filled Mammary Prosthesis, Natrelle 410® Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant. Premarket Approval Application (PMA) Number P040046. Allergan, Inc. Silicone Gel-Filled Breast Implants, Premarket Approval Application (PMA) Number P020056: FDA Summary of Safety and Effectiveness Data (SSED).In the second modeling the prototype used was made from blue gel with a volume of 350cc, a width of 11.5 cm, a height of 17 cm and a profile of 2.5 cm the prototype was inserted under fitted black top with a V neckline.įigures 3 (before) is the native breast, figure 4 (after) with the blue implant in frontal view and figure 6 is a lateral view to demonstrates the aesthetic performance of the blue DefyGravity prototype. The prototype dimensions were suitable for the chest and breast anatomy of the model.įigure 1 (before) demonstrates the native breast size and shape in frontal view figure 2 (after) demonstrates the aesthetic performance of DefyGravity breast implant in frontal view, and figure 5 demonstrates the implant performance in 3/4 view. In the first modeling DefyGravity prototype with a volume of 540cc, width 12 cm, height 17 cm and a profile of 5.2 cm inserted into a desired bra cup D on both sides. ![]() In this design trial the aesthetic performance of two DefyGravity protypes with different sizes and dimensions is visualized using frontal and 3/4 view photographs. Both models signed a consent to the study. The second model is a multiparous women using DefyGravity breast implant to imitate breast lift. She inserts DefyGravity implants under her bra on both sides to imitate breast augmentation. ![]() She is wearing either a black bra with the desired cup size D, or a fitted black top with deep V neck. The Models: The first model is a young female who lost breast volume after weight loss. commercially available round implant sizer is compared. In the comparative study, the characteristic “new look” in clothes of DefyGravity breast implant vs. The assessment criteria used to assess changes in the shape of the breast are: fullness of breast upper pole, upper pole slope, implant reach to upper breast border, upper pole to lower pole ratio, medial cleavage, and gain in bra cup size. The goal is to imitate the “new look” of using DefyGravity breast implant in breast augmentation and lift-augmentation surgeries.Įffectiveness Assessment: The trial was designed based on pre-operative consultations performed by surgeons with their patients in preparation for breast augmentation. Materials and Methods Photography: in this study, the characteristic aesthetic outcomes of using DefyGravity breast implant are "visualized" and communicated by photographs.īefore- and after-insertion photos with the model “trying on” different sizes of DefyGravity breast implant prototype in frontal and lateral views are shown. ![]()
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