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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MemoryGel Breast Implant Participants | MemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery |
| |
| Saline Breast Implant Control Participants | Saline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentor Silicone Gel-Filled Breast Implants | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Reoperations | Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years | 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
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MemoryGelâ„¢ PAS uses a current cohort design of 41,900 gel participants and 1,000 saline participants.
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| Name | Affiliation | Role |
|---|---|---|
| John Canady, M.D. | Mentor Worldwide, LLC | Study Director |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | MemoryGel Breast Implant Participants | Subjects who received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery |
| FG001 | Saline Breast Implant Control Participants | Subjects who received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Original Phase |
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| Re-Op Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Original Phase - MemoryGel Participants | Subjects implanted with MemoryGel breast implants |
| BG001 | Original Phase - Saline Breast Implant Control Participants | Subjects implanted with saline filled breast implants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Number | 95% Confidence Interval | Cumulative Reoperation Events | 10 years |
|
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In the Original study, follow-up data were to be collected by survey in years 1-10. Surgeons were also to see MemoryGel participants in years 1, 4-6, and 9-10. All local complications, reasons for reoperation, and reasons for removal reported by the participant or surgeon were to be recorded. In 2015 FDA approved a redesign of the study whereby data collection was limited to only reoperation data for MemoryGel participants and the reasons for reoperation. These are presented as Outcome Measures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study | Subjects in either the MemoryGel group or the saline breast implant control group |
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The data presented may represent an under-estimation of reoperation and explantation rates due to the lack of mandatory safety reporting and ability for participants to be treated at non-study sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sponsor | Mentor Worldwide, LLC | 949-453-6408 | mgpas@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2015 | Jun 2, 2020 | Prot_SAP_000.pdf |
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| Saline Breast Implants | Device |
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| Other Discontinuation |
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| Participant Noncompliance |
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| Unknown Discontinuation Reason |
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| Participants without data |
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| Death |
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| Not due for F/U at Phase One closure |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Surgery Indication | Number | Participants |
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Subjects who received MemoryGel breast implants
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Cumulative Explantation Events | 10 years |
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| Secondary | Reasons for Reoperations | Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years | 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. | Posted | Number | Reoperation events | 10 Years |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| 2 Years |
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| 3 Years |
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| 4 Years |
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| 5 Years |
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| 6 Years |
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| 7 Years |
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| 8 Years |
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| 9 Years |
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| 10 Years |
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| Title | Measurements |
|---|---|
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| Breast pain not associated with other complication |
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| Calcification |
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| Capsular Contracture (Baker Grade II) |
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| Capsular Contracture (Baker Grade III) |
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| Capsular Contracture (Baker Grade IV) |
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| Capsule / Pocket tear |
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| Delayed wound healing |
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| Extrusion |
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| Granuloma |
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| Hematoma |
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| Hypertrophic scarring |
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| Implant removal |
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| Infection |
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| Irritation / Inflammation |
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| Lack of projection |
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| Necrosis |
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| New diagnosis of breast cancer |
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| New diagnosis of rheumatic disease |
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| Nipple - unacceptably low sensitivity |
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| Nipple complications |
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| Palpability - implant |
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| Position change (dissatisfaction) |
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| Ptosis |
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| Rupture |
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| Seroma |
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| Size change - patient request |
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| Size change - physician assessment only |
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| Staged Reconstruction |
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| Symmastia |
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| Wrinkling |
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| Unknown |
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| Other |
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