MGPAS: Mentor MemoryGel Post-Approval Study

Sponsor
Mentor Worldwide, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00756652
Collaborator
(none)
42,491
152.9

Study Details

Study Description

Brief Summary

In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.

Condition or Disease Intervention/Treatment Phase
  • Device: Mentor Silicone Gel-Filled Breast Implants
  • Device: Saline Breast Implants

Study Design

Study Type:
Observational
Actual Enrollment :
42491 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study
Actual Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm Intervention/Treatment
MemoryGel Breast Implant Participants

MemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery

Device: Mentor Silicone Gel-Filled Breast Implants
Other Names:
  • MemoryGel Breast Implants
  • Saline Breast Implant Control Participants

    Saline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery

    Device: Saline Breast Implants

    Outcome Measures

    Primary Outcome Measures

    1. Kaplan Meier Estimated Cumulative Incidence of Reported Complications [10 years]

      The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.

    2. Kaplan Meier Estimated Cumulative Incidence of Explantation [10 years]

      The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.

    Secondary Outcome Measures

    1. Reasons for Reoperations [10 Years]

      Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Female, age 18 years or older (22 or older for breast augmentation patients)

    2. U.S. resident

    Exclusion Criteria:
    1. If a saline participant, current or past, unilateral or bilateral, silicone breast implants

    2. Active infection anywhere in her body

    3. Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions

    4. Currently pregnant or nursing

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mentor Worldwide, LLC

    Investigators

    • Study Director: John Canady, M.D., Mentor Worldwide, LLC

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Mentor Worldwide, LLC
    ClinicalTrials.gov Identifier:
    NCT00756652
    Other Study ID Numbers:
    • P030053
    • NCT00495534
    First Posted:
    Sep 22, 2008
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    Jun 1, 2020

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail In January 2015, the FDA approved a protocol amendment that limited the scope of the study to the collection of only secondary procedure and reoperation data for the MemoryGel arm participants. No data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.
    Arm/Group Title MemoryGel Breast Implant Participants Saline Breast Implant Control Participants
    Arm/Group Description Subjects who received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery Subjects who received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery
    Period Title: Original Phase
    STARTED 41452 1039
    COMPLETED 6063 118
    NOT COMPLETED 35389 921
    Period Title: Original Phase
    STARTED 11101 0
    COMPLETED 8225 0
    NOT COMPLETED 2876 0

    Baseline Characteristics

    Arm/Group Title Original Phase - MemoryGel Participants Original Phase - Saline Breast Implant Control Participants Total
    Arm/Group Description Subjects implanted with MemoryGel breast implants Subjects implanted with saline filled breast implants Total of all reporting groups
    Overall Participants 41452 1039 42491
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    40.3
    (11.4)
    32.1
    (9.9)
    40.1
    (11.5)
    Sex: Female, Male (Count of Participants)
    Female
    41452
    100%
    1039
    100%
    42491
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Number) [Number]
    White, not of Hispanic origin
    32216
    77.7%
    575
    55.3%
    32791
    77.2%
    White, of Hispanic origin
    4123
    9.9%
    262
    25.2%
    4385
    10.3%
    Black, not of Hispanic origin
    891
    2.1%
    28
    2.7%
    919
    2.2%
    Black, of Hispanic origin
    146
    0.4%
    11
    1.1%
    157
    0.4%
    Asian, Asian American, Pacific Islander
    1873
    4.5%
    74
    7.1%
    1947
    4.6%
    Native American or Alaskan Native
    306
    0.7%
    8
    0.8%
    314
    0.7%
    Other
    1025
    2.5%
    44
    4.2%
    1069
    2.5%
    Missing
    872
    2.1%
    37
    3.6%
    909
    2.1%
    Surgery Indication (Number) [Number]
    Primary Augmentation
    26173
    63.1%
    937
    90.2%
    27110
    63.8%
    Revision Augmentation
    8382
    20.2%
    75
    7.2%
    8457
    19.9%
    Primary Reconstruction
    5023
    12.1%
    15
    1.4%
    5038
    11.9%
    Revision Reconstruction
    1761
    4.2%
    9
    0.9%
    1770
    4.2%
    Unknown Indication
    113
    0.3%
    3
    0.3%
    116
    0.3%

    Outcome Measures

    1. Primary Outcome
    Title Kaplan Meier Estimated Cumulative Incidence of Reported Complications
    Description The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
    Time Frame 10 years

    Outcome Measure Data

    Analysis Population Description
    Per the FDA-approved protocol amendment, no data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm. The number of participants each year is based on participants with post-op follow-up in that year
    Arm/Group Title MemoryGel Participants
    Arm/Group Description Subjects who received MemoryGel breast implants
    Measure Participants 41452
    0 Years
    0.0
    1 Year
    6.7
    2 Years
    10.8
    3 Years
    11.2
    4 Years
    11.7
    5 Years
    12.5
    6 Years
    13.0
    7 Years
    13.2
    8 Years
    13.3
    9 Years
    13.6
    10 Years
    13.7
    2. Primary Outcome
    Title Kaplan Meier Estimated Cumulative Incidence of Explantation
    Description The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.
    Time Frame 10 years

    Outcome Measure Data

    Analysis Population Description
    Per the FDA-approved protocol amendment, no data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm. The number of participants each year is based on participants with post-op follow-up in that year.
    Arm/Group Title MemoryGel Participants
    Arm/Group Description Subjects who received MemoryGel breast implants
    Measure Participants 41452
    0 Years
    0
    1 Year
    3.0
    2 Years
    5.0
    3 Years
    5.2
    4 Years
    5.5
    5 Years
    6.0
    6 Years
    6.4
    7 Years
    6.5
    8 Years
    6.6
    9 Years
    6.8
    10 Years
    6.9
    3. Secondary Outcome
    Title Reasons for Reoperations
    Description Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years
    Time Frame 10 Years

    Outcome Measure Data

    Analysis Population Description
    In January 2015, the FDA approved a protocol amendment that limited the scope of the study to the collection of only secondary procedure and reoperation data for the MemoryGel arm participants. No data collection is required for the Saline Breast Implant Control group participants and no outcome measures are reported for this study arm.
    Arm/Group Title MemoryGel Participants
    Arm/Group Description Subjects who received MemoryGel breast implants
    Measure Participants 1141
    Asymmetry
    465
    Biopsy
    17
    Breast - unacceptably high sensation
    2
    Breast pain not associated with other complication
    26
    Calcification
    1
    Capsular Contracture (Baker Grade II)
    238
    Capsular Contracture (Baker Grade III)
    423
    Capsular Contracture (Baker Grade IV)
    224
    Capsule / Pocket tear
    23
    Delayed wound healing
    37
    Extrusion
    90
    Granuloma
    2
    Hematoma
    128
    Hypertrophic scarring
    104
    Implant removal
    76
    Infection
    142
    Irritation / Inflammation
    12
    Lack of projection
    54
    Necrosis
    11
    New diagnosis of breast cancer
    17
    New diagnosis of rheumatic disease
    1
    Nipple - unacceptably low sensitivity
    2
    Nipple complications
    25
    Palpability - implant
    9
    Position change (dissatisfaction)
    313
    Ptosis
    128
    Rupture
    41
    Seroma
    33
    Size change - patient request
    624
    Size change - physician assessment only
    37
    Staged Reconstruction
    7
    Symmastia
    26
    Wrinkling
    76
    Unknown
    513
    Other
    139

    Adverse Events

    Time Frame
    Adverse Event Reporting Description In the Original study, follow-up data were to be collected by survey in years 1-10. Surgeons were also to see MemoryGel participants in years 1, 4-6, and 9-10. All local complications, reasons for reoperation, and reasons for removal reported by the participant or surgeon were to be recorded. In 2015 FDA approved a redesign of the study whereby data collection was limited to only reoperation data for MemoryGel participants and the reasons for reoperation. These are presented as Outcome Measures.
    Arm/Group Title Overall Study
    Arm/Group Description Subjects in either the MemoryGel group or the saline breast implant control group
    All Cause Mortality
    Overall Study
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)
    Serious Adverse Events
    Overall Study
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Overall Study
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)

    Limitations/Caveats

    The data presented may represent an under-estimation of reoperation and explantation rates due to the lack of mandatory safety reporting and ability for participants to be treated at non-study sites.

    More Information

    Certain Agreements

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

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Sponsor
    Organization Mentor Worldwide, LLC
    Phone 949-453-6408
    Email mgpas@its.jnj.com
    Responsible Party:
    Mentor Worldwide, LLC
    ClinicalTrials.gov Identifier:
    NCT00756652
    Other Study ID Numbers:
    • P030053
    • NCT00495534
    First Posted:
    Sep 22, 2008
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    Jun 1, 2020