Breast Augmentation
Conditions
Brief summary
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
Interventions
DEVICEnew texture shaped breast implants
breast implant surgery
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Overall Satisfaction With the Device Using a 5-Point Scale | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire | 6 months | 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. |
| Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue | 6 months | 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. |
| Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | Interim analysis: 12 months | 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. |
| Percentage of Participants With Local Complications | Interim analysis: 12 months | The percentage of participants experiencing local complications (in the area of the implant) is reported. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Al participants who had new texture shaped breast implants surgically implanted. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient had device explantation | 4 |
| Overall Study | Study Ongoing | 15 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 29.3 years STANDARD_DEVIATION 9.57 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 19 |
| serious Total, serious adverse events | 2 / 19 |
Outcome results
Primary
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
Population: Full analysis population included all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Investigator Overall Satisfaction With the Device Using a 5-Point Scale | 4.6 score on a scale | Standard Deviation 0.77 |
Secondary
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
Population: Full analysis population included all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue | 2.5 score on a scale | Standard Deviation 0.77 |
Secondary
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
Population: Participants from the Full Analysis population with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | Baker Grade II | 11.1 percentage of participants |
| All Participants | Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | Baker Grade I | 88.9 percentage of participants |
| All Participants | Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | Baker Grade III | 0.0 percentage of participants |
| All Participants | Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | Baker Grade IV | 0.0 percentage of participants |
Secondary
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
Population: Full analysis population included all participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Percentage of Participants With Local Complications | Breast pain | 100.0 percentage of participants |
| All Participants | Percentage of Participants With Local Complications | Implant malposition | 15.8 percentage of participants |
Secondary
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
Population: Full analysis population included all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire | 87.1 score on a scale | Standard Deviation 16.95 |