Mentor MemoryGel Post-Approval Study

Study Overview
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Brief Summary
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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.

Official Title
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MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study

Conditions
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Breast Reconstruction, Breast Augmentation, Breast Revision

Intervention / Treatment
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* Device: Mentor Silicone Gel-Filled Breast Implants
* Device: Saline Breast Implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, age 18 years or older (22 or older for breast augmentation patients) U.S. resident Exclusion Criteria: If a saline participant, current or past, unilateral or bilateral, silicone breast implants Active infection anywhere in her body Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions Currently pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MemoryGel Breast Implant Participants<br>MemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery | Device: Mentor Silicone Gel-Filled Breast Implants<br> <br> * Other names: MemoryGel Breast Implants;|
| Saline Breast Implant Control Participants<br>Saline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery | Device: Saline Breast Implants<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |