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

Sponsor
Allergan (Industry)
Overall Status
Terminated
CT.gov ID
NCT01870869
Collaborator
(none)
1,951
Enrollment
58
Locations
4
Arms
30.1
Actual Duration (Months)
33.6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1951 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
Actual Study Start Date :
May 29, 2013
Actual Primary Completion Date :
Nov 30, 2015
Actual Study Completion Date :
Nov 30, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Augmentation

Women who had breast augmentation with NATRELLE® 410 implants.

Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
Surgical implant
Other Names:
  • NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)

    		•
    Experimental: Reconstruction

    Women who had breast reconstruction with NATRELLE® 410 implants.

    Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
    Surgical implant
    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

    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
    Surgical implant
    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

    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
    Other Names:
  • NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants According to Investigator Satisfaction With Implants [5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)]

      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.

    2. Percentage of Participants According to Participant Satisfaction With Implants [5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)]

      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 Outcome Measures

    1. Percentage of Participants With Local Complications [5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)]

      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 .

    2. Percentage of Participants With Reoperations [5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)]

      Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.

    3. Percentage of Participants With Implant Removal With or Without Replacement [5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)]

      Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement is reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anthony Griffin Beverly Hills California United States 90211
    2 Laurence Berkowitz Campbell California United States 95008
    3 Mary Powers Long Beach California United States 90806
    4 Roy Hong Palo Alto California United States 94301
    5 Eric Bachelor Pleasanton California United States 94566
    6 Douglas Reavie San Diego California United States 92128
    7 Steven Teitelbaum Santa Monica California United States 90404
    8 Tad Heinz Colorado Springs Colorado United States 80909
    9 Gary Snider Denver Colorado United States 80218
    10 Terrence Murphy Englewood Colorado United States 80113
    11 Orlando De Lucia Farmington Connecticut United States 06032
    12 Lewis Berger Tampa Florida United States 33607
    13 Gerard Mosiello Tampa Florida United States 33647
    14 James Namnoum Atlanta Georgia United States 30342
    15 Peter Johnson Des Plaines Illinois United States 60016
    16 Stephen Madry Elk Grove Village Illinois United States 60007
    17 Janet Turkle Carmel Indiana United States 46290
    18 Bruce Van Natta Indianapolis Indiana United States 46290
    19 Christine Kelley-Patteson Indianapolis Indiana United States 46290
    20 Brad Storm Olathe Kansas United States 66061
    21 Julene Samuels Louisville Kentucky United States 40241
    22 Timothy Mickel Monroe Louisiana United States 71201
    23 Paul Davis Shreveport Louisiana United States 71105
    24 Bradley Bengtson Grand Rapids Michigan United States 49503
    25 John Renucci Grand Rapids Michigan United States 49503
    26 Steven Morris Midland Michigan United States 48640
    27 Charles Nathan Chesterfield Missouri United States 63005
    28 Herluf Lund Jr. Chesterfield Missouri United States 63005
    29 Patricia McGuire Creve Coeur Missouri United States 63141
    30 Schuyler Meltis Hannibal Missouri United States 63401
    31 Perry Johnson Omaha Nebraska United States 68102
    32 Perry Johnson Omaha Nebraska United States 68118
    33 Peter Hyans Berkeley Heights New Jersey United States 07922
    34 Isaac Starker Florham Park New Jersey United States 07932
    35 Peter Hetzler Little Silver New Jersey United States 07739
    36 Marc Alan Drimmer Princeton New Jersey United States 08540
    37 Caroline Glicksman Sea Girt New Jersey United States 08750
    38 Lloyd Gayle New York New York United States 10021
    39 John Sherman New York New York United States 10028
    40 Tracy Pfeifer New York New York United States 10028
    41 Robert Jacobs Port Jefferson Station New York United States 11776
    42 John Decorato Staten Island New York United States 10306
    43 Raymond Isakov Cleveland Ohio United States 44195
    44 Craig Colville Toledo Ohio United States 43615
    45 Frank Barone Toledo Ohio United States 43623
    46 Derek Shadid Oklahoma City Oklahoma United States 73134
    47 Robert Hein Oklahoma City Oklahoma United States 73134
    48 Mark Jewell Eugene Oregon United States 97401
    49 John Lettieri Spartanburg South Carolina United States 29303
    50 Kristina D. O'Shaughnessy Nashville Tennessee United States 37203
    51 Patrick Maxwell Nashville Tennessee United States 37212
    52 William Carpenter Dallas Texas United States 75246
    53 Jeffrey Friedman Houston Texas United States 77030
    54 Natan Yaker Plano Texas United States 75093
    55 William Adams University Park Texas United States 75205
    56 Gloria Duda McLean Virginia United States 22101
    57 Gavin Dry Bellevue Washington United States 98005
    58 Allen Gabriel Vancouver Washington United States 98664

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Chair: Andrew Schumacher, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01870869
    Other Study ID Numbers:
    • 410CAXL-001
    First Posted:
    Jun 6, 2013
    Last Update Posted:
    Jun 22, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
    Period Title: Overall Study
    STARTED 288 206 1222 235
    COMPLETED 260 192 1092 205
    NOT COMPLETED 28 14 130 30

    Baseline Characteristics

    Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction Total
    Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of previous breast reconstruction with NATRELLE® 410 implants. Total of all reporting groups
    Overall Participants 278 201 1180 225 1884
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    34.5
    47.3
    50.3
    54.4
    48.1
    Sex: Female, Male (Count of Participants)
    Female
    278
    100%
    201
    100%
    1180
    100%
    225
    100%
    1884
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants According to Investigator Satisfaction With Implants
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants from the Evaluable population, all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device, with data available for analysis.
    Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
    Measure Participants 77 34 247 52
    Definitely satisfied
    94.8
    34.1%
    85.3
    42.4%
    74.1
    6.3%
    73.1
    32.5%
    Somewhat satisfied
    3.9
    1.4%
    8.8
    4.4%
    21.5
    1.8%
    23.1
    10.3%
    2. Primary Outcome
    Title Percentage of Participants According to Participant Satisfaction With Implants
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants from the Evaluable population, all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device, with data available for analysis.
    Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
    Measure Participants 77 34 247 52
    Definitely satisfied
    88.3
    31.8%
    76.5
    38.1%
    68.0
    5.8%
    65.4
    29.1%
    Somewhat satisfied
    5.2
    1.9%
    17.6
    8.8%
    24.7
    2.1%
    25.0
    11.1%
    3. Secondary Outcome
    Title Percentage of Participants With Local Complications
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Evaluable population was defined as all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device.
    Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
    Measure Participants 278 201 1180 225
    Any complication
    6.62
    2.4%
    9.09
    4.5%
    14.50
    1.2%
    10.19
    4.5%
    Asymmetry
    1.11
    0.4%
    1.99
    1%
    2.34
    0.2%
    2.67
    1.2%
    Breast pain
    1.93
    0.7%
    1.08
    0.5%
    0.51
    0%
    1.07
    0.5%
    Capsular contracture
    1.85
    0.7%
    7.90
    3.9%
    20.14
    1.7%
    27.03
    12%
    Delayed wound healing
    0.00
    0%
    0.50
    0.2%
    0.34
    0%
    1.78
    0.8%
    Fluid accumulation/seroma
    0.37
    0.1%
    0.50
    0.2%
    0.57
    0%
    1.78
    0.8%
    Hematoma
    0.00
    0%
    0.00
    0%
    0.43
    0%
    0.44
    0.2%
    Hypertrophic scarring/other abnormal scarring
    0.72
    0.3%
    1.29
    0.6%
    0.75
    0.1%
    0.44
    0.2%
    Implant extrusion
    0.00
    0%
    0.00
    0%
    0.98
    0.1%
    0.60
    0.3%
    Implant malposition
    2.21
    0.8%
    1.00
    0.5%
    1.22
    0.1%
    1.33
    0.6%
    Implant palpability/visibility
    0.48
    0.2%
    0.00
    0%
    0.25
    0%
    0.44
    0.2%
    Implant rupture
    2.14
    0.8%
    6.15
    3.1%
    2.03
    0.2%
    3.84
    1.7%
    Infection
    0.36
    0.1%
    1.49
    0.7%
    1.21
    0.1%
    3.18
    1.4%
    Redness
    0.00
    0%
    0.50
    0.2%
    0.83
    0.1%
    3.31
    1.5%
    Skin rash
    0.36
    0.1%
    0.00
    0%
    0.08
    0%
    0.00
    0%
    Swelling
    0.72
    0.3%
    0.00
    0%
    0.17
    0%
    0.44
    0.2%
    Tissue/skin necrosis
    0.00
    0%
    0.00
    0%
    0.17
    0%
    0.50
    0.2%
    Upper pole fullness
    0.00
    0%
    0.00
    0%
    0.00
    0%
    0.44
    0.2%
    Wrinkling/rippling
    0.00
    0%
    0.50
    0.2%
    1.61
    0.1%
    0.00
    0%
    Other complications
    1.46
    0.5%
    2.99
    1.5%
    4.37
    0.4%
    1.43
    0.6%
    4. Secondary Outcome
    Title Percentage of Participants With Reoperations
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Evaluable population was defined as all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device.
    Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
    Measure Participants 278 201 1180 225
    Number (95% Confidence Interval) [percentage of participants]
    13.02
    4.7%
    25.08
    12.5%
    39.70
    3.4%
    35.75
    15.9%
    5. Secondary Outcome
    Title Percentage of Participants With Implant Removal With or Without Replacement
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Evaluable population was defined as all participants enrolled under this study protocol who received a NATRELLE® 410 X- or L-style device.
    Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
    Measure Participants 278 201 1180 225
    Number (95% Confidence Interval) [percentage of participants]
    7.17
    2.6%
    19.09
    9.5%
    19.54
    1.7%
    20.59
    9.2%

    Adverse Events

    Time Frame 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
    Adverse Event Reporting Description Adverse events were not collected in this study. Deaths are reported as Serious Adverse Events. Specific local complications were collected and are reported in the Outcome Measure section. Evaluable population.
    Arm/Group Title Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Arm/Group Description Women who had breast augmentation with NATRELLE® 410 implants. Women who had revision of previous breast augmentation with NATRELLE® 410 implants. Women who had breast reconstruction with NATRELLE® 410 implants. Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
    All Cause Mortality
    Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/278 (0%) 0/201 (0%) 7/1180 (0.6%) 1/225 (0.4%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 0/278 (0%) 0/201 (0%) 2/1180 (0.2%) 0/225 (0%)
    Metastatic carcinoma to liver 0/278 (0%) 0/201 (0%) 1/1180 (0.1%) 0/225 (0%)
    Recurrence of breast cancer 0/278 (0%) 0/201 (0%) 1/1180 (0.1%) 0/225 (0%)
    Liver cancer 0/278 (0%) 0/201 (0%) 0/1180 (0%) 1/225 (0.4%)
    Metastatic breast cancer 0/278 (0%) 0/201 (0%) 2/1180 (0.2%) 0/225 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary hypertension 0/278 (0%) 0/201 (0%) 1/1180 (0.1%) 0/225 (0%)
    Other (Not Including Serious) Adverse Events
    Augmentation Revision-Augmentation Reconstruction Revision-Reconstruction
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Therapeutic Area, Head
    Organization Allergan
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01870869
    Other Study ID Numbers:
    • 410CAXL-001
    First Posted:
    Jun 6, 2013
    Last Update Posted:
    Jun 22, 2020
    Last Verified:
    Jun 1, 2020