Breast Augmentation, Breast Implant Revision, Breast Reconstruction
Conditions
Brief summary
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
Interventions
DEVICEAnatomically shaped silicone gel-filled breast implants
Surgical implant
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Styles 410 FM, FF, MM, or MF in 1 (for unilateral breast reconstruction or revision) or both breasts. * Female, age 18 or older * Present with one or more of the following conditions: * Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction, with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia * Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when permanent implants are placed in the reconstructed breast) * Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants * Has adequate tissue available to cover implants * Willing to undergo MRI at the specified follow-up visit for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)
Exclusion criteria
For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and met the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction With Breast Implants on a 5-Point Scale | 5 years | Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts. |
| Investigator Satisfaction With Breast Implants on a 5-Point Scale | 5 years | Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts. |
| Local Complications | 5 years | Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented. |
Countries
United States
Participant flow
Recruitment details
The study was discontinued following product approval.
Participants by arm
| Arm | Count |
|---|---|
| Augmentation Women undergoing breast augmentation. | 1,939 |
| Revision-Augmentation Women undergoing revision of previous breast augmentation. | 693 |
| Reconstruction Women undergoing breast reconstruction. | 751 |
| Revision-Reconstruction Women undergoing revision of previous breast reconstruction. | 428 |
| Total | 3,811 |
Baseline characteristics
| Characteristic | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.0 Years STANDARD_DEVIATION 8.65 | 46.2 Years STANDARD_DEVIATION 9.96 | 49.8 Years STANDARD_DEVIATION 10.03 | 53.5 Years STANDARD_DEVIATION 9.11 | 42.5 Years STANDARD_DEVIATION 11.52 |
| Sex: Female, Male Female | 1939 Participants | 693 Participants | 751 Participants | 428 Participants | 3811 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,939 | 0 / 693 | 0 / 751 | 0 / 428 |
| serious Total, serious adverse events | 0 / 1,939 | 0 / 693 | 0 / 751 | 0 / 428 |
Outcome results
Primary
Investigator Satisfaction With Breast Implants on a 5-Point Scale
Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.
Time frame: 5 years
Population: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Augmentation | Investigator Satisfaction With Breast Implants on a 5-Point Scale | Definitely Satisfied | 1798 Subjects |
| Augmentation | Investigator Satisfaction With Breast Implants on a 5-Point Scale | Somewhat Satisfied | 97 Subjects |
| Revision-Augmentation | Investigator Satisfaction With Breast Implants on a 5-Point Scale | Somewhat Satisfied | 83 Subjects |
| Revision-Augmentation | Investigator Satisfaction With Breast Implants on a 5-Point Scale | Definitely Satisfied | 560 Subjects |
| Reconstruction | Investigator Satisfaction With Breast Implants on a 5-Point Scale | Definitely Satisfied | 564 Subjects |
| Reconstruction | Investigator Satisfaction With Breast Implants on a 5-Point Scale | Somewhat Satisfied | 141 Subjects |
| Revision-Reconstruction | Investigator Satisfaction With Breast Implants on a 5-Point Scale | Definitely Satisfied | 310 Subjects |
| Revision-Reconstruction | Investigator Satisfaction With Breast Implants on a 5-Point Scale | Somewhat Satisfied | 83 Subjects |
Primary
Local Complications
Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.
Time frame: 5 years
Population: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Augmentation | Local Complications | Asymmetry | 0.83 Percentage of Subjects |
| Augmentation | Local Complications | Capsular Contracture | 3.27 Percentage of Subjects |
| Revision-Augmentation | Local Complications | Capsular Contracture | 6.33 Percentage of Subjects |
| Revision-Augmentation | Local Complications | Asymmetry | 0.87 Percentage of Subjects |
| Reconstruction | Local Complications | Asymmetry | 5.94 Percentage of Subjects |
| Reconstruction | Local Complications | Capsular Contracture | 6.48 Percentage of Subjects |
| Revision-Reconstruction | Local Complications | Asymmetry | 3.32 Percentage of Subjects |
| Revision-Reconstruction | Local Complications | Capsular Contracture | 7.29 Percentage of Subjects |
Primary
Subject Satisfaction With Breast Implants on a 5-Point Scale
Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.
Time frame: 5 years
Population: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Augmentation | Subject Satisfaction With Breast Implants on a 5-Point Scale | Definitely Satisfied | 1772 Subjects |
| Augmentation | Subject Satisfaction With Breast Implants on a 5-Point Scale | Somewhat Satisfied | 119 Subjects |
| Revision-Augmentation | Subject Satisfaction With Breast Implants on a 5-Point Scale | Somewhat Satisfied | 87 Subjects |
| Revision-Augmentation | Subject Satisfaction With Breast Implants on a 5-Point Scale | Definitely Satisfied | 559 Subjects |
| Reconstruction | Subject Satisfaction With Breast Implants on a 5-Point Scale | Definitely Satisfied | 542 Subjects |
| Reconstruction | Subject Satisfaction With Breast Implants on a 5-Point Scale | Somewhat Satisfied | 145 Subjects |
| Revision-Reconstruction | Subject Satisfaction With Breast Implants on a 5-Point Scale | Definitely Satisfied | 295 Subjects |
| Revision-Reconstruction | Subject Satisfaction With Breast Implants on a 5-Point Scale | Somewhat Satisfied | 89 Subjects |