European New Texture Implant Clinical Experience With Shaped Breast Implants

Allergan19 enrolled

Overview

The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Augmentation

Interventions

new texture shaped breast implantsDEVICE

breast implant surgery

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only * Be a candidate for the device styles and sizes available in the study Exclusion Criteria: * Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis * Have undergone any previous breast surgery * Have tissue covering determined inadequate or unsuitable by the surgeon

Locations (2)

Klinik 34

Göteburg, Sweden

Akademikliniken 10

Stockholm, Sweden

Outcomes

Primary Outcomes

Investigator Overall Satisfaction With the Device Using a 5-Point Scale

The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.

Time frame: 3 months

Secondary Outcomes

Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire

Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.

Time frame: 6 months

Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue

The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.

Time frame: 6 months

Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale

The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.

Time frame: Interim analysis: 12 months

Percentage of Participants With Local Complications

The percentage of participants experiencing local complications (in the area of the implant) is reported.

Time frame: Interim analysis: 12 months

Data from ClinicalTrials.gov

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