NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study

Study Overview
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Brief Summary
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This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants for breast augmentation, reconstruction, or revision.

Official Title
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NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study

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 height/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 either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts; or be planning to be implanted with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and meet the inclusion criteria listed below: Female, age 18 or older (age 22 or older for breast augmentation participants who are implanted under Protocol 410CAXL-001) Present with 1 or more of the following conditions: Primary breast augmentation (i.e., no previous breast implant surgery) indicated for participant 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 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 Exclusion Criteria: For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and did not meet the exclusion criteria listed below or plan to undergo implantation with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and does not meet the exclusion criteria listed below: Has an advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy Has an existing carcinoma of the breast, without mastectomy Has an abscess or infection in the body at the time of enrollment Is pregnant or nursing Has any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) > 8%), that is clinically known to impact wound healing ability Shows tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration Has or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems) Shows 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 height/projection or extra-full projection<br>* Surgical implant<br>* Other names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF);|
| Experimental: Reconstruction<br>Women who had breast reconstruction with NATRELLE® 410 implants. | Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection<br>* Surgical implant<br>* Other names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF);|
| Experimental: Revision-Augmentation<br>Women who had revision of previous breast augmentation with NATRELLE® 410 implants. | Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection<br>* Surgical implant<br>* Other names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF);|
| Experimental: Revision-Reconstruction<br>Women who had revision of previous breast reconstruction with NATRELLE® 410 implants. | Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection<br>* Surgical implant<br>* Other names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF);|

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. | 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015) | 
| 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. | 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015) | 

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, Hematoma, Hypertrophic scarring/other abnormal scarring, Implant extrusion, Implant malposition, Implant palpability/visibility, Implant rupture, Infection, Redness, Skin rash, Swelling, Tissue/skin necrosis, Upper pole fullness, Wrinkling/rippling and Other complications . | 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015) | 
| 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 06 May 2008 and 08 January 2015) | 
| 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 is reported. | 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015) |