European New Texture Implant Clinical Experience With Shaped Breast Implants

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

Official Title
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European New Texture Implant Clinical Experience With Shaped Breast Implants

Conditions
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Breast Augmentation

Intervention / Treatment
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* Device: new texture shaped breast implants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants<br>Al participants who had new texture shaped breast implants surgically implanted. | Device: new texture shaped breast implants<br>* breast implant surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Interim analysis: 12 months |