Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

Study Overview
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Brief Summary
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This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.

Official Title
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A Prospective Multicenter Study of the Safety and Effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-filled X-style and L-style Breast Implants

Conditions
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Breast Augmentation, Breast Reconstruction, Breast Implant Revision

Intervention / Treatment
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* Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For entry in this study, participants must have been enrolled in the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Styles or L-Styles breast implants Female, age 18 or older Present with 1 or more of the following conditions: Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when the permanent implants are placed in the reconstructed breast) Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants Has adequate tissue available to cover implants Willing to undergo magnetic resonance imaging (MRI) at the specified follow-up visits for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia) Exclusion Criteria: For entry in this study, participants must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study, meeting the exclusion criteria listed below, did not receive any NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled FM, FF, MM, or MF Style Breast Implants, and have not undergone implant removal with or without replacement surgery Does not have advance fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy Does not have existing carcinoma of the breast, without mastectomy Does not have abscess or infection in the body at the time of enrollment Is not pregnant or nursing Does not have any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) > 8%), that is clinically known to impact wound healing ability Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation inadequate tissue, compromised vascularity, or ulceration Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems) Does not show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder) Is not willing to undergo further surgery for revision, if medically required

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmentation<br>Women who had breast augmentation with NATRELLE® 410 implants. | Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection<br>* Surgical implant<br>* Other names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants;|
| Experimental: Reconstruction<br>Women who had breast reconstruction with NATRELLE® 410 implants. | Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection<br>* Surgical implant<br>* Other names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants;|
| Experimental: Revision-Augmentation<br>Women who had revision of a previous breast augmentation with NATRELLE® 410 implants. | Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection<br>* Surgical implant<br>* Other names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants;|
| Experimental: Revision-Reconstruction<br>Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants. | Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection<br>* Surgical implant<br>* Other names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants According to Investigator Satisfaction With Implants | The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied,3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: Definitely satisfied or Somewhat satisfied is reported. | 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | 
| Percentage of Participants According to Participant Satisfaction With Implants | The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: Definitely satisfied or Somewhat satisfied is reported. | 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Local Complications | Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast Pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Implant malposition, Implant palpability/visibility. Implant rupture, Infection, Ptosis, Redness, Swelling, Wrinkling/rippling and Other complications (calcifications on mammogram, thing of mastectomy flap, deformity and nipple stretching). | 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | 
| Percentage of Participants With Reoperations | Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported. | 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | 
| Percentage of Participants With Implant Removal With or Without Replacement | Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement | 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) |