Breast Augmentation, Breast Reconstruction, Breast Revision
Conditions
Keywords
Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone breast implants
Brief summary
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
Interventions
DEVICESilimed Gel-Filled Mammary Implant
Sponsors
Tiger Biosciences, LLC.
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
No
Inclusion criteria
Subjects are admitted into the study only if all of the following eligibility is true: * Female * Age limitation specific to the indication: * Primary Augmentation: Must be 18 years or older * Primary Reconstruction: No age limit * Revision: If original surgery was primary reconstruction, then no age limit. If original surgery was primary augmentation, then must be 18 years or older. * Adequate tissue available to cover implant(s) * Willingness to follow study requirements (informed consent form, follow-up visits) * Candidate for primary augmentation, primary reconstruction, or revision
Exclusion criteria
Subjects are not eligible if any of the following criteria exist: * Advanced fibrocystic disease, considered to be pre-malignant without mastectomy * Inadequate or unsuitable tissue * Active infection in the body at the time of surgery * Pregnant or lactating * Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator * Use of drugs, including any drug that would interfere with blood clotting, that might result in high risk and/or significant postoperative complications * Demonstrated psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure * Determination by physical examination that the subject does have any connective tissue/autoimmune disorder * Existing carcinoma of the breast without accompanying mastectomy * MRI scan is prohibited because of implanted metal device, claustrophobia, or other condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Complications | 10 Years | Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Determined by Patients | 10 Years | Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. The patient satisfaction measures through 10 years provided in the table below are based on questionnaire responses of Strongly Agree and Agree. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Augmentation Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant | 1,116 |
| Revision-Augmentation Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant | 363 |
| Primary Reconstruction Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant | 225 |
| Revision-Reconstruction Silimed Gel-Filled Mammary Implant
Silimed Gel-Filled Mammary Implant | 84 |
| Total | 1,788 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death (not device related) | 10 | 4 | 15 | 8 |
| Overall Study | Explantation of study device(s) | 78 | 47 | 28 | 21 |
| Overall Study | Lost to Follow-up | 299 | 103 | 51 | 12 |
| Overall Study | Subject Request | 41 | 17 | 13 | 11 |
Baseline characteristics
| Characteristic | Primary Augmentation | Revision-Augmentation | Primary Reconstruction | Revision-Reconstruction | Total |
|---|---|---|---|---|---|
| Age, Customized ≤18 | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants |
| Age, Customized 18-21 | 47 participants | 3 participants | 7 participants | 0 participants | 57 participants |
| Age, Customized 22-25 | 102 participants | 12 participants | 5 participants | 0 participants | 119 participants |
| Age, Customized 26-39 | 566 participants | 128 participants | 55 participants | 8 participants | 757 participants |
| Age, Customized 40-49 | 335 participants | 139 participants | 67 participants | 26 participants | 567 participants |
| Age, Customized 50-59 | 57 participants | 63 participants | 62 participants | 29 participants | 211 participants |
| Age, Customized 60-69 | 8 participants | 18 participants | 17 participants | 14 participants | 57 participants |
| Age, Customized 70 & over | 1 participants | 0 participants | 10 participants | 7 participants | 18 participants |
| Race/Ethnicity, Customized Asian | 29 participants | 8 participants | 1 participants | 0 participants | 38 participants |
| Race/Ethnicity, Customized Black | 12 participants | 7 participants | 5 participants | 2 participants | 26 participants |
| Race/Ethnicity, Customized Caucasian | 1014 participants | 338 participants | 204 participants | 80 participants | 1636 participants |
| Race/Ethnicity, Customized Hispanic | 37 participants | 7 participants | 10 participants | 1 participants | 55 participants |
| Race/Ethnicity, Customized Indian | 1 participants | 0 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Not Provided | 1 participants | 1 participants | 2 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Other | 22 participants | 2 participants | 2 participants | 1 participants | 27 participants |
| Region of Enrollment United States | 1116 participants | 363 participants | 225 participants | 84 participants | 1788 participants |
| Sex: Female, Male Female | 1116 Participants | 363 Participants | 225 Participants | 84 Participants | 1788 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 | 10 / 1,116 | 4 / 363 | 15 / 225 | 8 / 84 |
| other Total, other adverse events | 360 / 1,116 | 122 / 363 | 100 / 225 | 45 / 84 |
| serious Total, serious adverse events | 0 / 1,116 | 0 / 363 | 0 / 225 | 0 / 84 |
Outcome results
Primary
Local Complications
Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.
Time frame: 10 Years
Population: All subjects are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Augmentation | Local Complications | Breast Pain | 12 Participants |
| Primary Augmentation | Local Complications | Baker grade III/IV Capsular Contracture | 120 Participants |
| Primary Augmentation | Local Complications | Rupture | 42 Participants |
| Primary Augmentation | Local Complications | Explantation with or without replacement for either cosmetic, medical, or surgical reasons | 151 Participants |
| Revision-Augmentation | Local Complications | Baker grade III/IV Capsular Contracture | 39 Participants |
| Revision-Augmentation | Local Complications | Explantation with or without replacement for either cosmetic, medical, or surgical reasons | 79 Participants |
| Revision-Augmentation | Local Complications | Breast Pain | 7 Participants |
| Revision-Augmentation | Local Complications | Rupture | 9 Participants |
| Primary Reconstruction | Local Complications | Breast Pain | 8 Participants |
| Primary Reconstruction | Local Complications | Explantation with or without replacement for either cosmetic, medical, or surgical reasons | 73 Participants |
| Primary Reconstruction | Local Complications | Rupture | 7 Participants |
| Primary Reconstruction | Local Complications | Baker grade III/IV Capsular Contracture | 27 Participants |
| Revision-Reconstruction | Local Complications | Explantation with or without replacement for either cosmetic, medical, or surgical reasons | 36 Participants |
| Revision-Reconstruction | Local Complications | Breast Pain | 2 Participants |
| Revision-Reconstruction | Local Complications | Baker grade III/IV Capsular Contracture | 9 Participants |
| Revision-Reconstruction | Local Complications | Rupture | 5 Participants |
Secondary
Satisfaction Determined by Patients
Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. The patient satisfaction measures through 10 years provided in the table below are based on questionnaire responses of Strongly Agree and Agree.
Time frame: 10 Years
Population: All patients that completed the Patient Satisfaction survey at Year 10.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her look healthy. | 414 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more sensual. | 504 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants improve her family life. | 118 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her look normal. | 444 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel better about herself. | 469 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her clothes feel better. | 482 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more feminine. | 549 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants improve her sex life. | 319 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants improve her daily relations with husband or partner. | 295 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more attractive. | 525 Participants |
| Primary Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants improve her social life. | 178 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more attractive. | 145 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants improve her social life. | 47 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel better about herself. | 137 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants improve her family life. | 29 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more feminine. | 153 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants improve her sex life. | 85 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more sensual. | 141 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants improve her daily relations with husband or partner. | 79 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her clothes feel better. | 138 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her look normal. | 121 Participants |
| Revision-Augmentation | Satisfaction Determined by Patients | Patient thinks her breast implants make her look healthy. | 110 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants improve her daily relations with husband or partner. | 32 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her look healthy. | 58 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her look normal. | 68 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more feminine. | 70 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more sensual. | 57 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her clothes feel better. | 65 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more attractive. | 64 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel better about herself. | 63 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants improve her family life. | 18 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants improve her social life. | 26 Participants |
| Primary Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants improve her sex life. | 31 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more attractive. | 21 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants improve her sex life. | 9 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants improve her social life. | 12 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her clothes feel better. | 23 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more sensual. | 17 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel more feminine. | 24 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants improve her daily relations with husband or partner. | 13 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her look normal. | 22 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her look healthy. | 20 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants improve her family life. | 10 Participants |
| Revision-Reconstruction | Satisfaction Determined by Patients | Patient thinks her breast implants make her feel better about herself. | 22 Participants |