Breast ReconstructionMGPASNCT00756652

Mentor MemoryGel Post-Approval Study

An observational study of Breast Reconstruction and Breast Augmentation, run by Mentor Worldwide, LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Reconstruction, Breast Augmentation, Breast Revision
What is being tested?: Mentor Silicone Gel-Filled Breast Implants and Saline Breast Implants
Type of treatment: Medical device
How many people: 42,491 participants
Where: No sites listed yet
Study dates: 1 Nov 2006to 31 Jul 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: MemoryGel™ PAS uses a current cohort design of 41,900 gel participants and 1,000 saline participants.

Who may be able to join

Female, age 18 years or older (22 or older for breast augmentation patients)
U.S. resident

Who cannot join

If a saline participant, current or past, unilateral or bilateral, silicone breast implants
Active infection anywhere in her body
Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
Currently pregnant or nursing

About this study

Official title: MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study

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.

Conditions: Breast Reconstruction, Breast Augmentation, Breast Revision
Being tested: Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mentor Silicone Gel-Filled Breast ImplantsDevice
Also called MemoryGel Breast Implants
Saline Breast ImplantsDevice

Study groups in NCT00756652
Study group	Role	What they receive
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 Receives: Device: Mentor Silicone Gel-Filled 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 Receives: Device: Saline Breast Implants

What is being measured

The primary outcome is the main question the study is designed to answer.

Kaplan Meier Estimated Cumulative Incidence of Reported Complications
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.
Measured: 10 years
Kaplan Meier Estimated Cumulative Incidence of Explantation
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.
Measured: 10 years

Secondary outcomes (1)

Reasons for Reoperations
Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years
Measured: 10 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 200631 Jul 2019

First posted22 Sep 2008 (estimated)
Study start1 Nov 2006
Primary completion31 Jul 2019
Study completion31 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast ReconstructionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 42,491 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00756652
Sponsor's protocol ID: P030053
Acronym: MGPAS
Status last verified: Jun 2020
First submitted: 18 Sep 2008
Last updated: 4 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Breast Reconstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study
ClinicalTrials.gov ID: NCT00756652
Acronym / sponsor ID: MGPAS / P030053
Conditions: Breast Reconstruction, Breast Augmentation, Breast Revision
Study type: Observational
Recruitment status: Completed
Enrolment: 42,491 participants (actual)
Lead sponsor: Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
Study start: 1 Nov 2006 (actual)
Primary completion: 31 Jul 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 22 Sep 2008 (estimated)
Results: Posted 4 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
MemoryGel Breast Implant Participants	–	Device: Mentor Silicone Gel-Filled Breast ImplantsMemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery
Saline Breast Implant Control Participants	–	Device: Saline Breast ImplantsSaline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: MemoryGel™ PAS uses a current cohort design of 41,900 gel participants and 1,000 saline participants.

Key inclusion criteria (2 listed)

Female, age 18 years or older (22 or older for breast augmentation patients)
U.S. resident

Key exclusion criteria (4 listed)

If a saline participant, current or past, unilateral or bilateral, silicone breast implants
Active infection anywhere in her body
Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
Currently pregnant or nursing

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mentor Silicone Gel-Filled Breast ImplantsAlso: MemoryGel Breast Implants	Device	MemoryGel Breast Implant Participants
Saline Breast Implants	Device	Saline Breast Implant Control Participants

Primary outcome

Kaplan Meier Estimated Cumulative Incidence of Reported Complications
Time frame: 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.
Kaplan Meier Estimated Cumulative Incidence of Explantation
Time frame: 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.

1 secondary outcome

Reasons for Reoperations
Time frame: 10 Years

Results and safety

Results posted to the registry on 4 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MemoryGel Breast Implant Participants	41,452	6,063
Saline Breast Implant Control Participants	1,039	118

Primary outcome: Kaplan Meier Estimated Cumulative Incidence of Reported Complications

Time frame: 10 years. Number (95% Confidence Interval). Unit: Cumulative Reoperation Events

Measure	MemoryGel Participants n = 41452
0 Years	0.0 (0 to 0)
1 Year	6.7 (6.2 to 7.2)
2 Years	10.8 (10.1 to 11.4)
3 Years	11.2 (10.5 to 11.8)
4 Years	11.7 (11.0 to 12.4)
5 Years	12.5 (11.8 to 13.2)
6 Years	13.0 (12.3 to 13.8)
7 Years	13.2 (12.5 to 14.0)

Population analysed: 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

Primary outcome: Kaplan Meier Estimated Cumulative Incidence of Explantation

Time frame: 10 years. Number (95% Confidence Interval). Unit: Cumulative Explantation Events

Measure	MemoryGel Participants n = 41452
0 Years	0 (0 to 0)
1 Year	3.0 (2.7 to 3.4)
2 Years	5.0 (4.6 to 5.5)
3 Years	5.2 (4.7 to 5.7)
4 Years	5.5 (5.0 to 6.1)
5 Years	6.0 (5.4 to 6.5)
6 Years	6.4 (5.8 to 6.9)
7 Years	6.5 (6.0 to 7.1)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Study	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1
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Active, not recruitingObservational study
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Not yet recruiting
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Canady, M.D. study director

Mentor Worldwide, LLC

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Reconstruction and Breast Augmentation, run by Mentor Worldwide, LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan Meier Estimated Cumulative Incidence of Reported Complications (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00756652.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.