Breast Augmentation, Breast Reconstruction, Breast Revision
Conditions
Brief summary
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.
Interventions
DEVICEMentor Silicone Gel-Filled Breast Implants
DEVICESaline Breast Implants
Sponsors
Mentor Worldwide, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Female, age 18 years or older (22 or older for breast augmentation patients) 2. U.S. resident
Exclusion criteria
1. If a saline participant, current or past, unilateral or bilateral, silicone breast implants 2. Active infection anywhere in her body 3. Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions 4. Currently pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 10 years | The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis. |
| Kaplan Meier Estimated Cumulative Incidence of Explantation | 10 years | The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for Reoperations | 10 Years | Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years |
Participant flow
Pre-assignment details
In January 2015, the FDA approved a protocol amendment that limited the scope of the study to the collection of only secondary procedure and reoperation data for the MemoryGel arm participants. No data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.
Participants by arm
| Arm | Count |
|---|---|
| Original Phase - MemoryGel Participants Subjects implanted with MemoryGel breast implants | 41,452 |
| Original Phase - Saline Breast Implant Control Participants Subjects implanted with saline filled breast implants | 1,039 |
| Total | 42,491 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Original Phase | Death | 168 | 1 |
| Original Phase | Lost to Follow-up | 601 | 0 |
| Original Phase | Not due for F/U at Phase One closure | 11,076 | 2 |
| Original Phase | Other Discontinuation | 797 | 5 |
| Original Phase | Participant Noncompliance | 18,622 | 424 |
| Original Phase | Participants without data | 3,259 | 466 |
| Original Phase | Unknown Discontinuation Reason | 2 | 0 |
| Original Phase | Withdrawal by Subject | 864 | 23 |
| Re-Op Phase | Death | 6 | 0 |
| Re-Op Phase | Lost to Follow-up | 340 | 0 |
| Re-Op Phase | Site Closed | 2,454 | 0 |
| Re-Op Phase | Withdrawal by Subject | 62 | 0 |
| Re-Op Phase | Withdrawn after explant | 14 | 0 |
Baseline characteristics
| Characteristic | Original Phase - MemoryGel Participants | Total | Original Phase - Saline Breast Implant Control Participants |
|---|---|---|---|
| Age, Continuous | 40.3 Years STANDARD_DEVIATION 11.4 | 40.1 Years STANDARD_DEVIATION 11.5 | 32.1 Years STANDARD_DEVIATION 9.9 |
| Race/Ethnicity, Customized Asian, Asian American, Pacific Islander | 1873 Participants | 1947 Participants | 74 Participants |
| Race/Ethnicity, Customized Black, not of Hispanic origin | 891 Participants | 919 Participants | 28 Participants |
| Race/Ethnicity, Customized Black, of Hispanic origin | 146 Participants | 157 Participants | 11 Participants |
| Race/Ethnicity, Customized Missing | 872 Participants | 909 Participants | 37 Participants |
| Race/Ethnicity, Customized Native American or Alaskan Native | 306 Participants | 314 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 1025 Participants | 1069 Participants | 44 Participants |
| Race/Ethnicity, Customized White, not of Hispanic origin | 32216 Participants | 32791 Participants | 575 Participants |
| Race/Ethnicity, Customized White, of Hispanic origin | 4123 Participants | 4385 Participants | 262 Participants |
| Sex: Female, Male Female | 41452 Participants | 42491 Participants | 1039 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgery Indication Primary Augmentation | 26173 Participants | 27110 Participants | 937 Participants |
| Surgery Indication Primary Reconstruction | 5023 Participants | 5038 Participants | 15 Participants |
| Surgery Indication Revision Augmentation | 8382 Participants | 8457 Participants | 75 Participants |
| Surgery Indication Revision Reconstruction | 1761 Participants | 1770 Participants | 9 Participants |
| Surgery Indication Unknown Indication | 113 Participants | 116 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Kaplan Meier Estimated Cumulative Incidence of Explantation
The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
Time frame: 10 years
Population: Per the FDA-approved protocol amendment, no data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.~The number of participants each year is based on participants with post-op follow-up in that year.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 4 Years | 5.5 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 5 Years | 6.0 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 8 Years | 6.6 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 9 Years | 6.8 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 10 Years | 6.9 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 0 Years | 0 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 1 Year | 3.0 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 2 Years | 5.0 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 3 Years | 5.2 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 6 Years | 6.4 Cumulative Explantation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Explantation | 7 Years | 6.5 Cumulative Explantation Events |
Primary
Kaplan Meier Estimated Cumulative Incidence of Reported Complications
The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
Time frame: 10 years
Population: Per the FDA-approved protocol amendment, no data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.~The number of participants each year is based on participants with post-op follow-up in that year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 2 Years | 10.8 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 3 Years | 11.2 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 9 Years | 13.6 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 0 Years | 0.0 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 1 Year | 6.7 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 4 Years | 11.7 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 5 Years | 12.5 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 6 Years | 13.0 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 7 Years | 13.2 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 8 Years | 13.3 Cumulative Reoperation Events |
| MemoryGel Participants | Kaplan Meier Estimated Cumulative Incidence of Reported Complications | 10 Years | 13.7 Cumulative Reoperation Events |
Secondary
Reasons for Reoperations
Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years
Time frame: 10 Years
Population: In January 2015, the FDA approved a protocol amendment that limited the scope of the study to the collection of only secondary procedure and reoperation data for the MemoryGel arm participants. No data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MemoryGel Participants | Reasons for Reoperations | Asymmetry | 465 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Hypertrophic scarring | 104 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Implant removal | 76 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Infection | 142 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Irritation / Inflammation | 12 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Lack of projection | 54 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Necrosis | 11 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | New diagnosis of breast cancer | 17 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | New diagnosis of rheumatic disease | 1 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Nipple - unacceptably low sensitivity | 2 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Seroma | 33 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Size change - patient request | 624 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Size change - physician assessment only | 37 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Staged Reconstruction | 7 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Symmastia | 26 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Wrinkling | 76 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Unknown | 513 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Other | 139 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Nipple complications | 25 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Palpability - implant | 9 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Granuloma | 2 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Hematoma | 128 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Biopsy | 17 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Breast - unacceptably high sensation | 2 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Breast pain not associated with other complication | 26 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Calcification | 1 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Capsular Contracture (Baker Grade II) | 238 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Capsular Contracture (Baker Grade III) | 423 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Capsular Contracture (Baker Grade IV) | 224 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Capsule / Pocket tear | 23 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Delayed wound healing | 37 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Extrusion | 90 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Position change (dissatisfaction) | 313 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Ptosis | 128 Reoperation events |
| MemoryGel Participants | Reasons for Reoperations | Rupture | 41 Reoperation events |