Breast Augmentation, Breast Implant Revision, Breast Reconstruction
Conditions
Brief summary
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.
Interventions
DEVICEAnatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Surgical implant
Sponsors
Allergan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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: 1. 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 2. 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) 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants According to Investigator Satisfaction With Implants | 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | 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. |
| Percentage of Participants According to Participant Satisfaction With Implants | 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local Complications | 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | 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). |
| Percentage of Participants With Reoperations | 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported. |
| Percentage of Participants With Implant Removal With or Without Replacement | 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012) | Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Augmentation Women who had breast augmentation with NATRELLE® 410 implants. | 100 |
| Revision-Augmentation Women who had revision of a previous breast augmentation with NATRELLE® 410 implants. | 72 |
| Reconstruction Women who had breast reconstruction with NATRELLE® 410 implants. | 99 |
| Revision-Reconstruction Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants. | 60 |
| Total | 331 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 2 | 0 |
| Overall Study | Implanted with nonstudy device | 1 | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 4 | 1 |
| Overall Study | Not evaluable | 7 | 4 | 5 | 8 |
| Overall Study | Reason not Specified | 1 | 2 | 1 | 4 |
| Overall Study | Subject choice | 2 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35.1 years | 48.3 years | 51.8 years | 54.7 years | 46.5 years |
| Sex: Female, Male Female | 100 Participants | 72 Participants | 99 Participants | 60 Participants | 331 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 100 | 2 / 72 | 0 / 99 | 0 / 60 |
Outcome results
Primary
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.
Time frame: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Population: Participants from the Evaluable population, all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Augmentation | Percentage of Participants According to Investigator Satisfaction With Implants | 99.0 percentage of participants |
| Revision-Augmentation | Percentage of Participants According to Investigator Satisfaction With Implants | 97.0 percentage of participants |
| Reconstruction | Percentage of Participants According to Investigator Satisfaction With Implants | 100.0 percentage of participants |
| Revision-Reconstruction | Percentage of Participants According to Investigator Satisfaction With Implants | 95.9 percentage of participants |
Primary
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.
Time frame: 3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Population: Participants from the Evaluable population, all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Augmentation | Percentage of Participants According to Participant Satisfaction With Implants | 99.0 percentage of participants |
| Revision-Augmentation | Percentage of Participants According to Participant Satisfaction With Implants | 95.5 percentage of participants |
| Reconstruction | Percentage of Participants According to Participant Satisfaction With Implants | 94.9 percentage of participants |
| Revision-Reconstruction | Percentage of Participants According to Participant Satisfaction With Implants | 91.8 percentage of participants |
Secondary
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
Time frame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Population: Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Augmentation | Percentage of Participants With Implant Removal With or Without Replacement | 1.05 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Implant Removal With or Without Replacement | 12.42 percentage of participants |
| Reconstruction | Percentage of Participants With Implant Removal With or Without Replacement | 2.35 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Implant Removal With or Without Replacement | 6.13 percentage of participants |
Secondary
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).
Time frame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Population: Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Augmentation | Percentage of Participants With Local Complications | Infection | 0.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Implant malposition | 3.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Implant palpability/visibility | 0.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Implant rupture | 3.09 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Fluid accumulation/seroma | 0.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Ptosis | 0.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Swelling | 1.05 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Other complications | 1.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Any complication | 9.05 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Asymmetry | 1.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Breast pain | 2.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Redness | 1.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Capsular contracture | 3.05 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Wrinkling/rippling | 0.00 percentage of participants |
| Augmentation | Percentage of Participants With Local Complications | Delayed wound healing | 0.00 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Infection | 1.39 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Other complications | 2.78 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Implant malposition | 4.17 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Any complication | 15.71 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Implant rupture | 12.64 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Delayed wound healing | 1.39 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Implant palpability/visibility | 1.39 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Swelling | 0.00 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Redness | 0.00 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Capsular contracture | 3.12 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Asymmetry | 0.00 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Ptosis | 1.39 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Wrinkling/rippling | 2.78 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Breast pain | 0.00 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Local Complications | Fluid accumulation/seroma | 1.39 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Delayed wound healing | 0.00 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Any complication | 15.28 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Breast pain | 1.01 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Wrinkling/rippling | 0.00 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Asymmetry | 3.03 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Capsular contracture | 4.40 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Fluid accumulation/seroma | 0.00 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Implant malposition | 4.04 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Implant palpability/visibility | 0.00 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Implant rupture | 2.16 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Infection | 2.02 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Ptosis | 0.00 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Redness | 2.02 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Swelling | 0.00 percentage of participants |
| Reconstruction | Percentage of Participants With Local Complications | Other complications | 2.12 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Other complications | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Infection | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Swelling | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Ptosis | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Asymmetry | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Any complication | 3.77 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Breast pain | 2.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Redness | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Wrinkling/rippling | 1.67 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Implant palpability/visibility | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Implant malposition | 1.67 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Delayed wound healing | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Implant rupture | 5.91 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Fluid accumulation/seroma | 0.00 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Local Complications | Capsular contracture | 3.67 percentage of participants |
Secondary
Percentage of Participants With Reoperations
Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Time frame: 5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Population: Evaluable population was defined as all screened participants who satisfied all eligibility criteria documented on the eligibility form, entered the study, and had a Year 3 office visit and MRI within the window.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Augmentation | Percentage of Participants With Reoperations | 9.07 percentage of participants |
| Revision-Augmentation | Percentage of Participants With Reoperations | 25.64 percentage of participants |
| Reconstruction | Percentage of Participants With Reoperations | 39.84 percentage of participants |
| Revision-Reconstruction | Percentage of Participants With Reoperations | 39.01 percentage of participants |