Breast Reconstruction
Conditions
Keywords
Revision of augmentation or reconstruction
Brief summary
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
Interventions
Breast implant surgery
Sponsors
Allergan Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate. * Females seeking revision augmentation or revision reconstruction, where problems exist * Have any of the following conditions or situations present: * Post mastectomy surgical removal of the breast for cancer or other disease; * Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity; * Severe ptosis requiring reconstruction; * Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity. * Adequate tissue available to cover implants. * Saline-filled implants are not an appropriate choice.
Exclusion criteria
* Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy. * Existing carcinoma of the breast, without mastectomy. * Abscess of infection in the body at the time of enrollment. * Pregnant or nursing. * Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability. * Show tissue characteristics which are clinically incompatible with mammaplasty. * Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk. * Are not willing to undergo further surgery for revision, if medically required. * Diagnosis of lupus or scleroderma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Complications | 5 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 | 5 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 |
|---|---|
| Reconstruction Women who have undergone Breast Reconstruction | 45,055 |
| Revision Women who have undergone Revision of a Breast Augmentation or Reconstruction | 39,274 |
| Total | 84,329 |
Baseline characteristics
| Characteristic | Reconstruction | Revision | Total |
|---|---|---|---|
| Age, Customized <=17 years | 115 participants | 4 participants | 119 participants |
| Age, Customized >=70 years | 1065 participants | 1039 participants | 2104 participants |
| Age, Customized Between 18 and 69 years | 43304 participants | 37612 participants | 80916 participants |
| Age, Customized Not provided | 571 participants | 619 participants | 1190 participants |
| Sex: Female, Male Female | 45055 Participants | 39274 Participants | 84329 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45,055 | 0 / 39,274 |
| serious Total, serious adverse events | 0 / 45,055 | 0 / 39,274 |
Outcome results
Primary
Local Complications
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Time frame: 5 years
Population: All enrolled patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reconstruction | Local Complications | Capsular Contracture | 15.0 Percentage by Patient |
| Reconstruction | Local Complications | Asymmetry | 11.1 Percentage by Patient |
| Reconstruction | Local Complications | Implant Palpability/Visibility | 7.1 Percentage by Patient |
| Reconstruction | Local Complications | Implant Malposition | 6.5 Percentage by Patient |
| Reconstruction | Local Complications | Wrinkling | 5.6 Percentage by Patient |
| Reconstruction | Local Complications | Breast Pain | 5.2 Percentage by Patient |
| Revision | Local Complications | Wrinkling | 8.9 Percentage by Patient |
| Revision | Local Complications | Capsular Contracture | 21.6 Percentage by Patient |
| Revision | Local Complications | Implant Malposition | 7.1 Percentage by Patient |
| Revision | Local Complications | Asymmetry | 10.7 Percentage by Patient |
| Revision | Local Complications | Breast Pain | 6.6 Percentage by Patient |
| Revision | Local Complications | Implant Palpability/Visibility | 11.4 Percentage by Patient |
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: 5 years
Population: All patients who had a breast implant satisfaction rating
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Reconstruction | 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 0.9 |
| Revision | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale | Physician Satisfaction | 4.3 Units on a scale | Standard Deviation 1 |
| Revision | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale | Patient Satisfaction | 4.3 Units on a scale | Standard Deviation 1 |