Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
Conditions
Brief summary
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, 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
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female, age 18 years or older * 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, or aplasia * Seeking primary breast reconstruction * Seeking breast revision-augmentation * Seeking breast revision-reconstruction * Adequate tissue available to cover implants * Patients at MRI designated sites must be willing to undergo MRI at their 1,3, 5, 7 and 9-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., HbAIc \> 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 occuring 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
Recruitment details
Enrollment: January 6, 1999-June 30, 2000 at multiple US sites
Participants by arm
| Arm | Count |
|---|---|
| Primary Augmentation All women implanted for an indication of primary breast augmentation | 455 |
| Primary Reconstruction All women implanted for an indication of primary breast reconstruction | 98 |
| Revision-augmentation All women implanted for revision of a breast augmentation | 147 |
| Revision-reconstruction All women implanted for revision of a breast reconstruction | 15 |
| Total | 715 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 10 | 2 | 2 |
| Overall Study | Explanted of All Study Devices | 36 | 25 | 29 | 3 |
| Overall Study | Lost to Follow-up | 123 | 13 | 37 | 1 |
| Overall Study | Physician Decision | 2 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 3 | 4 | 1 |
Baseline characteristics
| Characteristic | Primary Augmentation | Primary Reconstruction | Revision-augmentation | Revision-reconstruction | Total |
|---|---|---|---|---|---|
| Age, Customized <=40 years | 319 participants | 10 participants | 61 participants | 0 participants | 390 participants |
| Age, Customized >=60 years | 0 participants | 15 participants | 2 participants | 6 participants | 23 participants |
| Age, Customized Between 40 and 60 years | 136 participants | 73 participants | 84 participants | 9 participants | 302 participants |
| Sex: Female, Male Female | 455 Participants | 98 Participants | 147 Participants | 15 Participants | 715 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 / 455 | 0 / 98 | 0 / 147 | 0 / 15 |
| serious Total, serious adverse events | 0 / 455 | 0 / 98 | 0 / 147 | 0 / 15 |
Outcome results
Primary
Local Complications
By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts
Time frame: 10 years
Population: all enrolled patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Augmentation | Local Complications | Seroma/Fluid Accumulation | 1.8 percentage by patient |
| Primary Augmentation | Local Complications | Wrinkling | 1.8 percentage by patient |
| Primary Augmentation | Local Complications | Skin Rash | 0.9 percentage by patient |
| Primary Augmentation | Local Complications | Implant Palpability/Visibility | 1.6 percentage by patient |
| Primary Augmentation | Local Complications | Breast Pain | 11.5 percentage by patient |
| Primary Augmentation | Local Complications | Swelling | 9.2 percentage by patient |
| Primary Augmentation | Local Complications | Implant Malposition | 6.9 percentage by patient |
| Primary Augmentation | Local Complications | Bruising | 0.4 percentage by patient |
| Primary Augmentation | Local Complications | Nipple Complications | 6.3 percentage by patient |
| Primary Augmentation | Local Complications | Capsular Contracture | 18.9 percentage by patient |
| Primary Augmentation | Local Complications | Hypertrophic/Other Abnormal Scarring | 4.2 percentage by patient |
| Primary Augmentation | Local Complications | Asymmetry | 3.3 percentage by patient |
| Primary Reconstruction | Local Complications | Nipple Complications | 3.3 percentage by patient |
| Primary Reconstruction | Local Complications | Asymmetry | 23.2 percentage by patient |
| Primary Reconstruction | Local Complications | Skin Rash | 2.0 percentage by patient |
| Primary Reconstruction | Local Complications | Implant Palpability/Visibility | 6.4 percentage by patient |
| Primary Reconstruction | Local Complications | Swelling | 7.1 percentage by patient |
| Primary Reconstruction | Local Complications | Wrinkling | 10.2 percentage by patient |
| Primary Reconstruction | Local Complications | Hypertrophic/Other Abnormal Scarring | 5.5 percentage by patient |
| Primary Reconstruction | Local Complications | Seroma/Fluid Accumulation | 2.3 percentage by patient |
| Primary Reconstruction | Local Complications | Capsular Contracture | 24.6 percentage by patient |
| Primary Reconstruction | Local Complications | Breast Pain | 6.8 percentage by patient |
| Primary Reconstruction | Local Complications | Implant Malposition | 2.3 percentage by patient |
| Primary Reconstruction | Local Complications | Bruising | 1.0 percentage by patient |
| Revision-augmentation | Local Complications | Capsular Contracture | 28.7 percentage by patient |
| Revision-augmentation | Local Complications | Implant Malposition | 6.0 percentage by patient |
| Revision-augmentation | Local Complications | Breast Pain | 11.7 percentage by patient |
| Revision-augmentation | Local Complications | Swelling | 8.2 percentage by patient |
| Revision-augmentation | Local Complications | Nipple Complications | 1.4 percentage by patient |
| Revision-augmentation | Local Complications | Hypertrophic/Other Abnormal Scarring | 6.6 percentage by patient |
| Revision-augmentation | Local Complications | Asymmetry | 6.5 percentage by patient |
| Revision-augmentation | Local Complications | Wrinkling | 5.4 percentage by patient |
| Revision-augmentation | Local Complications | Implant Palpability/Visibility | 6.0 percentage by patient |
| Revision-augmentation | Local Complications | Seroma/Fluid Accumulation | 6.0 percentage by patient |
| Revision-augmentation | Local Complications | Bruising | 3.0 percentage by patient |
| Revision-augmentation | Local Complications | Skin Rash | 0.7 percentage by patient |
| Revision-reconstruction | Local Complications | Hypertrophic/Other Abnormal Scarring | 0 percentage by patient |
| Revision-reconstruction | Local Complications | Nipple Complications | 0 percentage by patient |
| Revision-reconstruction | Local Complications | Swelling | 0 percentage by patient |
| Revision-reconstruction | Local Complications | Seroma/Fluid Accumulation | 6.7 percentage by patient |
| Revision-reconstruction | Local Complications | Implant Malposition | 13.3 percentage by patient |
| Revision-reconstruction | Local Complications | Breast Pain | 0 percentage by patient |
| Revision-reconstruction | Local Complications | Skin Rash | 6.7 percentage by patient |
| Revision-reconstruction | Local Complications | Bruising | 6.7 percentage by patient |
| Revision-reconstruction | Local Complications | Wrinkling | 0 percentage by patient |
| Revision-reconstruction | Local Complications | Asymmetry | 6.7 percentage by patient |
| Revision-reconstruction | Local Complications | Capsular Contracture | 6.7 percentage by patient |
| Revision-reconstruction | Local Complications | Implant Palpability/Visibility | 6.7 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: 10 years
Population: All patients who had a breast implant satisfaction rating
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary 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 |
| Primary 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 |
| Primary 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 0.7 |
| Primary Reconstruction | Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale | Physician satisfaction | 4.7 units on a scale | Standard Deviation 0.6 |
| Revision-augmentation | 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 1.1 |
| 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 1.2 |
| Revision-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 1.1 |
| 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 1.4 |