Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
Conditions
Brief summary
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
Interventions
DEVICEStyle 410 Silicone-Filled Breast Implants
Breast Implant Surgery
Sponsors
Allergan Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female, age 18 years or older * Patients seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: Patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, aplasia * Patients seeking breast reconstruction * Patients seeking breast revision-augmentation * Patients seeking breast revision-reconstruction * Adequate tissue available to cover implants * Patients must be willing to undergo MRI at their 1, 3, 5, 7, and 10-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).
Exclusion criteria
* Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy * Existing carcinoma of the breast, without mastectomy * Abscess or infection in the body at the time of enrollment * Pregnant or nursing * Have any disease, including uncontrolled diabetes (e.g., Hb AIc \> 8%), that is clinically known to impact wound healing ability * Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration * Have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems) * Show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder) * Are not willing to undergo further surgery for revision, if medically required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Complications | 10 years | By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | 10 years | Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Augmentation Augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery | 492 |
| Reconstruction Reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery | 225 |
| Revision-augmentation Revision-augmentation
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery | 156 |
| Revision-reconstruction Revision-reconstruction
Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery | 68 |
| Total | 941 |
Baseline characteristics
| Characteristic | Augmentation | Reconstruction | Revision-augmentation | Revision-reconstruction | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 7 Participants | 0 Participants | 3 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 492 Participants | 218 Participants | 156 Participants | 65 Participants | 931 Participants |
| Sex: Female, Male Female | 492 Participants | 225 Participants | 156 Participants | 68 Participants | 941 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 / 492 | 0 / 225 | 0 / 156 | 0 / 68 |
| serious Total, serious adverse events | 0 / 492 | 0 / 225 | 0 / 156 | 0 / 68 |
Outcome results
Primary
Local Complications
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Time frame: 10 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Augmentation | Local Complications | Asymmetry | 1.2 Percentage of Patients |
| Augmentation | Local Complications | Implant Malposition | 4.7 Percentage of Patients |
| Augmentation | Local Complications | Swelling | 4.0 Percentage of Patients |
| Augmentation | Local Complications | Breast Pain | 4.5 Percentage of Patients |
| Augmentation | Local Complications | Wrinkling/Rippling | 0.9 Percentage of Patients |
| Augmentation | Local Complications | Capsular Contracture | 9.2 Percentage of Patients |
| Augmentation | Local Complications | Seroma/Fluid Accumulation | 1.6 Percentage of Patients |
| Augmentation | Local Complications | Infection | 1.7 Percentage of Patients |
| Reconstruction | Local Complications | Wrinkling/Rippling | 6.2 Percentage of Patients |
| Reconstruction | Local Complications | Swelling | 5.3 Percentage of Patients |
| Reconstruction | Local Complications | Seroma/Fluid Accumulation | 2.8 Percentage of Patients |
| Reconstruction | Local Complications | Implant Malposition | 5.7 Percentage of Patients |
| Reconstruction | Local Complications | Asymmetry | 12.4 Percentage of Patients |
| Reconstruction | Local Complications | Infection | 6.1 Percentage of Patients |
| Reconstruction | Local Complications | Capsular Contracture | 14.5 Percentage of Patients |
| Reconstruction | Local Complications | Breast Pain | 8.2 Percentage of Patients |
| Revision-augmentation | Local Complications | Breast Pain | 5.2 Percentage of Patients |
| Revision-augmentation | Local Complications | Capsular Contracture | 11.9 Percentage of Patients |
| Revision-augmentation | Local Complications | Asymmetry | 6.9 Percentage of Patients |
| Revision-augmentation | Local Complications | Wrinkling/Rippling | 3.7 Percentage of Patients |
| Revision-augmentation | Local Complications | Infection | 2.1 Percentage of Patients |
| Revision-augmentation | Local Complications | Implant Malposition | 9.1 Percentage of Patients |
| Revision-augmentation | Local Complications | Swelling | 2.7 Percentage of Patients |
| Revision-augmentation | Local Complications | Seroma/Fluid Accumulation | 3.2 Percentage of Patients |
| Revision-reconstruction | Local Complications | Asymmetry | 17.4 Percentage of Patients |
| Revision-reconstruction | Local Complications | Swelling | 3.2 Percentage of Patients |
| Revision-reconstruction | Local Complications | Wrinkling/Rippling | 12.8 Percentage of Patients |
| Revision-reconstruction | Local Complications | Breast Pain | 7.8 Percentage of Patients |
| Revision-reconstruction | Local Complications | Capsular Contracture | 26.8 Percentage of Patients |
| Revision-reconstruction | Local Complications | Seroma/Fluid Accumulation | 6.2 Percentage of Patients |
| Revision-reconstruction | Local Complications | Implant Malposition | 8.0 Percentage of Patients |
| Revision-reconstruction | Local Complications | Infection | 8.5 Percentage of Patients |
Secondary
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
Time frame: 10 years
Population: All patients who had a breast implant satisfaction rating
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Augmentation | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | Physician Satisfaction | 4.8 units on a scale | Standard Deviation 0.7 |
| Augmentation | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | Patient Satisfaction | 4.8 units on a scale | Standard Deviation 0.7 |
| Reconstruction | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | Patient Satisfaction | 4.6 units on a scale | Standard Deviation 0.8 |
| Reconstruction | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | Physician Satisfaction | 4.6 units on a scale | Standard Deviation 0.8 |
| Revision-augmentation | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | Physician Satisfaction | 4.5 units on a scale | Standard Deviation 1 |
| Revision-augmentation | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | Patient Satisfaction | 4.4 units on a scale | Standard Deviation 1.1 |
| Revision-reconstruction | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | Physician Satisfaction | 4.4 units on a scale | Standard Deviation 0.9 |
| Revision-reconstruction | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale. | Patient Satisfaction | 4.5 units on a scale | Standard Deviation 0.9 |