Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants

Study Overview
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Brief Summary
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This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.

Conditions
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Breast Implantation

Intervention / Treatment
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* Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants
* Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants
* Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants
* Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection Subfascial, submuscular, dual plane or subglandular implant placement Exclusion Criteria: Breast augmentation for Poland Syndrome or amastia Breast reconstruction following mastectomy Revision or secondary breast reconstruction Non NATRELLE® INSPIRA® device implanted at initial breast augmentation Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator Axillary or peri-areolar approach Mastopexy augmentation

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NATRELLE® INSPIRA® TruForm® 1 (Smooth)<br>Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 1 breast implants | Device: Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants<br>* Surgical implant<br>* Other names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection);|
| NATRELLE® INSPIRA® TruForm® 1 (Textured)<br>Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 1 breast implants | Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants<br>* surgical implant<br>* Other names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection);|
| NATRELLE® INSPIRA® TruForm® 2 (Smooth)<br>Subjects receiving primary breast augmentation with smooth NATRELLE® INSPIRA® TruForm® 2 breast implants | Device: Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants<br>* surgical implant<br>* Other names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection);|
| NATRELLE® INSPIRA® TruForm® 2 (Textured)<br>Subjects receiving primary breast augmentation with textured NATRELLE® INSPIRA® TruForm® 2 breast implants | Device: Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants<br>* surgical implant<br>* Other names: Round cohesive, gel-filled breast implants (low, low plus, moderate, full, or extra full projection);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants |  | 4 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence (by Product Type) of First Reoperation Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm®1 or TruForm® 2 Breast Implants |  | 4 Years | 
| Reasons For Primary Augmentation |  | 4 Years | 
| Time From the Date of Implant Until First Reoperation |  | 4 Years | 
| Reasons For Reoperation Incidence |  | 4 Years | 
| Incidences of Implant Removal With Replacement |  | 4 Years | 
| Incidences of Implant Removal Without Replacement |  | 4 Years |