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Mentor MemoryGel Post-Approval Study (MGPAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00756652
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Breast Reconstruction
Breast Augmentation
Breast Revision
Interventions Device: Mentor Silicone Gel-Filled Breast Implants
Device: Saline Breast Implants
Enrollment 42491
Recruitment Details  
Pre-assignment Details 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
Hide 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 [1] 118
Not Completed 35389 921
Reason Not Completed
Withdrawal by Subject             864             23
Lost to Follow-up             601             0
Other Discontinuation             797             5
Participant Noncompliance             18622             424
Unknown Discontinuation Reason             2             0
Participants without data             3259             466
Death             168             1
Not due for F/U at Phase One closure             11076             2
[1]
At Year 7
Period Title: Re-Op Phase
Started 11101 0 [1]
Completed 8225 0
Not Completed 2876 0
Reason Not Completed
Withdrawal by Subject             62             0
Death             6             0
Lost to Follow-up             340             0
Site Closed             2454             0
Withdrawn after explant             14             0
[1]
NA - The Re-Op Phase was limited in scope to data collection for only MemoryGel participants.
Arm/Group Title Original Phase - MemoryGel Participants Original Phase - Saline Breast Implant Control Participants Total
Hide Arm/Group Description Subjects implanted with MemoryGel breast implants Subjects implanted with saline filled breast implants Total of all reporting groups
Overall Number of Baseline Participants 41452 1039 42491
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41452 participants 1039 participants 42491 participants
40.3  (11.4) 32.1  (9.9) 40.1  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41452 participants 1039 participants 42491 participants
Female
41452
 100.0%
1039
 100.0%
42491
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41452 participants 1039 participants 42491 participants
White, not of Hispanic origin 32216 575 32791
White, of Hispanic origin 4123 262 4385
Black, not of Hispanic origin 891 28 919
Black, of Hispanic origin 146 11 157
Asian, Asian American, Pacific Islander 1873 74 1947
Native American or Alaskan Native 306 8 314
Other 1025 44 1069
Missing 872 37 909
Surgery Indication  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41452 participants 1039 participants 42491 participants
Primary Augmentation 26173 937 27110
Revision Augmentation 8382 75 8457
Primary Reconstruction 5023 15 5038
Revision Reconstruction 1761 9 1770
Unknown Indication 113 3 116
1.Primary Outcome
Title Kaplan Meier Estimated Cumulative Incidence of Reported Complications
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects who received MemoryGel breast implants
Overall Number of Participants Analyzed 41452
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Reoperation Events
0 Years Number Analyzed 11158 participants
0.0
(0 to 0)
1 Year Number Analyzed 8779 participants
6.7
(6.2 to 7.2)
2 Years Number Analyzed 4792 participants
10.8
(10.1 to 11.4)
3 Years Number Analyzed 4613 participants
11.2
(10.5 to 11.8)
4 Years Number Analyzed 4525 participants
11.7
(11.0 to 12.4)
5 Years Number Analyzed 4336 participants
12.5
(11.8 to 13.2)
6 Years Number Analyzed 4228 participants
13.0
(12.3 to 13.8)
7 Years Number Analyzed 4159 participants
13.2
(12.5 to 14.0)
8 Years Number Analyzed 4047 participants
13.3
(12.6 to 14.1)
9 Years Number Analyzed 3910 participants
13.6
(12.8 to 14.4)
10 Years Number Analyzed 3493 participants
13.7
(12.9 to 14.5)
2.Primary Outcome
Title Kaplan Meier Estimated Cumulative Incidence of Explantation
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects who received MemoryGel breast implants
Overall Number of Participants Analyzed 41452
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cumulative Explantation Events
0 Years Number Analyzed 11158 participants
0
(0 to 0)
1 Year Number Analyzed 9037 participants
3.0
(2.7 to 3.4)
2 Years Number Analyzed 5003 participants
5.0
(4.6 to 5.5)
3 Years Number Analyzed 4831 participants
5.2
(4.7 to 5.7)
4 Years Number Analyzed 4752 participants
5.5
(5.0 to 6.1)
5 Years Number Analyzed 4561 participants
6.0
(5.4 to 6.5)
6 Years Number Analyzed 4454 participants
6.4
(5.8 to 6.9)
7 Years Number Analyzed 4386 participants
6.5
(6.0 to 7.1)
8 Years Number Analyzed 4273 participants
6.6
(6.1 to 7.2)
9 Years Number Analyzed 4133 participants
6.8
(6.2 to 7.4)
10 Years Number Analyzed 3698 participants
6.9
(6.3 to 7.6)
3.Secondary Outcome
Title Reasons for Reoperations
Hide Description Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years
Time Frame 10 Years
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects who received MemoryGel breast implants
Overall Number of Participants Analyzed 1141
Measure Type: Number
Unit of Measure: Reoperation events
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
Time Frame [Not Specified]
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
Hide Arm/Group Description Subjects in either the MemoryGel group or the saline breast implant control group
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall Study
Affected / at Risk (%)
Total   0/0 
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.
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
Layout table for Results Point of Contact information
Name/Title: Sponsor
Organization: Mentor Worldwide, LLC
Phone: 949-453-6408
EMail: mgpas@its.jnj.com
Layout table for additonal information
Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00756652    
Obsolete Identifiers: NCT00495534
Other Study ID Numbers: P030053
First Submitted: September 18, 2008
First Posted: September 22, 2008
Results First Submitted: March 27, 2020
Results First Posted: June 4, 2020
Last Update Posted: June 4, 2020