An interventional study of Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection in Breast Augmentation, Breast Reconstruction and Breast Implant Revision, sponsored by Allergan. Terminated at 58 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-22.
Sponsored by Allergan · Not applicable, Interventional, and Treatment
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.
Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Present with 1 or more of the following conditions:
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:
Women who had breast augmentation with NATRELLE® 410 implants.
Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
Women who had breast reconstruction with NATRELLE® 410 implants.
Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
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
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
Surgical implant
Also known as: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)
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: 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.
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
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 .
Time frame: 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.
Time frame: 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.
Time frame: 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
| Milestone | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction |
|---|---|---|---|---|
| Started | 288 | 206 | 1222 | 235 |
| Completed | 260 | 192 | 1092 | 205 |
| Not completed | 28 | 14 | 130 | 30 |
| Withdrew: Implanted with nonstudy device | 1 | 3 | 14 | 4 |
| Withdrew: Death | 0 | 0 | 7 | 1 |
| Withdrew: Subject choice | 6 | 2 | 22 | 8 |
| Withdrew: Lost to follow-up | 10 | 2 | 25 | 3 |
| Withdrew: Reason not specified | 1 | 2 | 20 | 4 |
| Withdrew: Not evaluable | 10 | 5 | 42 | 10 |
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 | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction |
|---|---|---|---|---|
| Definitely satisfied | 94.8 | 85.3 | 74.1 | 73.1 |
| Somewhat satisfied | 3.9 | 8.8 | 21.5 | 23.1 |
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.
| percentage of participants | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction |
|---|---|---|---|---|
| Definitely satisfied | 88.3 | 76.5 | 68.0 | 65.4 |
| Somewhat satisfied | 5.2 | 17.6 | 24.7 | 25.0 |
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 .
| percentage of participants | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction |
|---|---|---|---|---|
| Any complication | 6.62 (3.78 to 11.45) | 9.09 (5.65 to 14.46) | 14.50 (11.78 to 17.78) | 10.19 (6.81 to 15.11) |
| Asymmetry | 1.11 (0.26 to 4.73) | 1.99 (0.75 to 5.21) | 2.34 (1.59 to 3.44) | 2.67 (1.21 to 5.84) |
| Breast pain | 1.93 (0.51 to 7.15) | 1.08 (0.15 to 7.39) | 0.51 (0.23 to 1.13) | 1.07 (0.26 to 4.30) |
| Capsular contracture | 1.85 (0.68 to 4.98) | 7.90 (3.57 to 17.01) | 20.14 (8.90 to 41.85) | 27.03 (9.04 to 64.93) |
| Delayed wound healing | 0.00 (0.00 to 0.00) | 0.50 (0.07 to 3.48) | 0.34 (0.13 to 0.90) | 1.78 (0.67 to 4.67) |
| Fluid accumulation/seroma | 0.37 (0.05 to 2.57) | 0.50 (0.07 to 3.48) | 0.57 (0.26 to 1.28) | 1.78 (0.67 to 4.67) |
| Hematoma | 0.00 (0.00 to 0.43) | 0.00 (0.00 to 0.00) | 0.43 (0.18 to 1.04) | 0.44 (0.06 to 3.11) |
| Hypertrophic scarring/other abnormal scarring | 0.72 (0.18 to 2.85) | 1.29 (0.32 to 5.12) | 0.75 (0.24 to 2.30) | 0.44 (0.06 to 3.11) |
| Implant extrusion | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.98 (0.40 to 2.38) | 0.60 (0.08 to 4.17) |
| Implant malposition | 2.21 (0.80 to 6.07) | 1.00 (0.25 to 3.92) | 1.22 (0.52 to 2.84) | 1.33 (0.43 to 4.08) |
| Implant palpability/visibility | 0.48 (0.07 to 3.33) | 0.00 (0.00 to 0.00) | 0.25 (0.08 to 0.79) | 0.44 (0.06 to 3.11) |
| Implant rupture | 2.14 (0.67 to 6.75) | 6.15 (1.77 to 20.22) | 2.03 (0.91 to 4.50) | 3.84 (1.39 to 10.38) |
| Infection | 0.36 (0.05 to 2.53) | 1.49 (0.48 to 4.56) | 1.21 (0.72 to 2.04) | 3.18 (1.53 to 6.56) |
| Redness | 0.00 (0.00 to 0.00) | 0.50 (0.07 to 3.48) | 0.83 (0.29 to 2.38) | 3.31 (1.01 to 10.59) |
| Skin rash | 0.36 (0.05 to 2.53) | 0.00 (0.00 to 0.00) | 0.08 (0.01 to 0.60) | 0.00 (0.00 to 0.00) |
| Swelling | 0.72 (0.18 to 2.85) | 0.00 (0.00 to 0.00) | 0.17 (0.04 to 0.68) | 0.44 (0.06 to 3.11) |
| Tissue/skin necrosis | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.17 (0.04 to 0.68) | 0.50 (0.07 to 3.51) |
| Upper pole fullness | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) | 0.44 (0.06 to 3.11) |
| Wrinkling/rippling | 0.00 (0.00 to 0.00) | 0.50 (0.07 to 3.48) | 1.61 (0.78 to 3.33) | 0.00 (0.00 to 0.00) |
| Other complications | 1.46 (0.45 to 4.70) | 2.99 (1.35 to 6.52) | 4.37 (2.94 to 6.46) | 1.43 (0.46 to 4.38) |
Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
| percentage of participants | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction |
|---|---|---|---|---|
| Percentage of Participants With Reoperations | 13.02 (8.42 to 19.84) | 25.08 (16.99 to 36.09) | 39.70 (35.35 to 44.38) | 35.75 (27.42 to 45.72) |
Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement is reported.
| percentage of participants | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction |
|---|---|---|---|---|
| Percentage of Participants With Implant Removal With or Without Replacement | 7.17 (3.80 to 13.31) | 19.09 (11.12 to 31.66) | 19.54 (15.79 to 24.03) | 20.59 (13.59 to 30.50) |
Collected over 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Augmentation | — | 0/278 (0%) | — |
| Revision-Augmentation | — | 0/201 (0%) | — |
| Reconstruction | — | 7/1,180 (0.6%) | — |
| Revision-Reconstruction | — | 1/225 (0.4%) | — |
| Event | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction |
|---|---|---|---|---|
| Liver cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/278 | 0/201 | 0/1180 | 1/225 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/278 | 0/201 | 2/1180 | 0/225 |
| Metastatic breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/278 | 0/201 | 2/1180 | 0/225 |
| Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders | 0/278 | 0/201 | 1/1180 | 0/225 |
| Metastatic carcinoma to liverNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/278 | 0/201 | 1/1180 | 0/225 |
| Recurrence of breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/278 | 0/201 | 1/1180 | 0/225 |
Evaluable population was defined as all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device.
| Age, Continuous(years) | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction | Total |
|---|---|---|---|---|---|
| Mean | 34.5 (18.0 to 63.0) | 47.3 (20.0 to 79.0) | 50.3 (21.0 to 79.0) | 54.4 (31.0 to 80.0) | 48.1 (18.0 to 80.0) |
| Sex: Female, Male(Participants) | Augmentation | Revision-Augmentation | Reconstruction | Revision-Reconstruction | Total |
|---|---|---|---|---|---|
| Female | 278 | 201 | 1180 | 225 | 1884 |
| Male | 0 | 0 | 0 | 0 | 0 |
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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