Breast AugmentationPhase 3CPGNCT00812097

Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial

A Phase 3 study testing Mentor Siltex® Contour Profile Gel Mammary Prosthesis in people with Breast Augmentation and Breast Reconstruction, run by Mentor Worldwide, LLC at 1 site in United States.

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 only
Conditions the study is for: Breast Augmentation, Breast Reconstruction, Breast Revision
What is being tested?: Mentor Siltex® Contour Profile Gel Mammary Prosthesis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 955 participants
Where: 1 siteUnited States
Study dates: Feb 2002to Oct 2014
Phase: Phase 3
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is genetic female, 18 years of age or older
A candidate for:
Primary breast augmentation (general breast enlargement)
Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry)
Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
Signs the Informed Consent
Agrees to return device to Mentor if explant necessary
Agrees to comply with follow-up procedures, including returning for all follow-up visits

Who cannot join

Subject is pregnant
Has nursed a child within three months of study enrollment
Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants)
Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
Subject in Augmentation cohort and has diagnosis of active cancer of any type. (Exception is low-grade non-metastasizing skin cancer)

Show all 16Show fewer

Infection or abscess anywhere in the body
Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
Premalignant breast disease without a subcutaneous mastectomy
Untreated or inappropriately treated breast malignancy, without mastectomy
Are HIV positive
Work for Mentor or the study doctor or are directly-related to anyone that works for Mentor or the study doctor
Implanted metal or metal devices, history of claustrophobia or other condition that would make a MRI scan prohibitive

Trial locations and contacts

1 site in 1 country.

United States1 site

Mentor Worldwide, LLC
Santa Barbara, California, 93111

Other trials in United States

About this study

Official title: Study of the Safety and Effectiveness of Mentor Siltex® Contour Profile Gel Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation,Primary Breast Reconstruction or Revision

The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety.

Approximately 1000 patients at approximately 60 medical centers across the United States were enrolled in this research study. These patients were implanted with silicone breast prostheses and will be monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.

Read the detailed description

Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as Class III devices requiring premarket approval. In May 1990, the Food and Drug Administration (FDA) published a proposed request (515(b)) for Premarket Approval Applications (PMA) and in April 1991 published the final request. This final publication put manufacturers of gel-filled breast implants on notice that for continued marketing of gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.

A premarket approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November 1991, the committee recommended the submission of additional information to establish the safety and effectiveness of gel-filled breast implants.

In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of gel-filled breast implants to allow the advisory panel time to assess additional information. In April 1992, the moratorium was lifted but only for reconstruction and revision patients. Every patient implanted had to be part of an adjunct study, and had to be offered participation in a registry of gel-filled breast implant patients. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in a core clinical study.

In September of 2000 the Core Gel study began, leading the way to the November 2006 FDA approval of the Core Gel implant or Memory Gel breast implant.

The objective of the Contour Profile Gel Study, which started in 2002 is to determine the safety and effectiveness of the Silicone Contour Profile Gel Mammary Prostheses in women who are undergoing primary breast augmentation, primary breast reconstruction, or revision. In the duration of this study patients are required to have follow-up visits 10 weeks post-surgery and every year after surgery through the 10th year of completion. Additionally, out of the approximately 1000 patients enrolled in the CPG study, 400 have been randomly selected to have MRI scans at their 1,2,4,6,8,and 10 year post-surgery visits. Protocol changes now require all patients in this study to have MRI scans at years 6, 8, and 10.

In June of 2013 the FDA approved MENTOR® MemoryShape™ Breast Implants (CPG Style 321 Medium Height, Moderate Profile) for the following indications:

Breast Augmentation for women at least 22 years old.
Breast Reconstruction.

Conditions: Breast Augmentation, Breast Reconstruction, Breast Revision
Being tested: Mentor Siltex® Contour Profile Gel Mammary Prosthesis
Keywords: Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone gel, Contour Profile Gel, Siltex®

What participants receive

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

Mentor Siltex® Contour Profile Gel Mammary ProsthesisDevice
The MENTOR® MemoryShape™ Breast Implant is a silicone elastomer mammary device with a textured surface.

Study groups in NCT00812097
Study group	Role	What they receive
Primary Augmentation	Other	The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants. Receives: Device: Mentor Siltex® Contour Profile Gel Mammary Prosthesis
Primary Reconstruction	Other	The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants. Receives: Device: Mentor Siltex® Contour Profile Gel Mammary Prosthesis
Revision Augmentation	Other	The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery. Receives: Device: Mentor Siltex® Contour Profile Gel Mammary Prosthesis
Revision Reconstruction	Other	The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery. Receives: Device: Mentor Siltex® Contour Profile Gel Mammary Prosthesis

What is being measured

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

10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Measured: 10 years
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
Baker III was identified as "firm with visible distortion" and Baker IV was identified as "obvious spherical distortion". Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Measured: 10 years
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Measured: 10 years
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Measured: 10 years
Overall Mean Change in Circumferential Chest Size
Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study
Measured: Change from baseline to 10 years post-baseline

Timeline

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

Feb 2002Oct 2014

First posted19 Dec 2008 (estimated)
Study startFeb 2002
Primary completionOct 2014
Study completionOct 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast AugmentationStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 955 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00812097
Sponsor's protocol ID: A105-0601-4
Acronym: CPG
Status last verified: Mar 2016
First submitted: 17 Dec 2008
Last updated: 5 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Caplin DA. Indications for the use of MemoryShape breast implants in aesthetic and reconstructive breast surgery: long-term clinical outcomes of shaped versus round silicone breast implants. Plast Reconstr Surg. 2014 Sep;134(3 Suppl):27S-37S. doi: 10.1097/PRS.0000000000000609.
PubMed 25158767

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Safety and Effectiveness of Mentor Siltex® Contour Profile Gel Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation,Primary Breast Reconstruction or Revision
ClinicalTrials.gov ID: NCT00812097
Acronym / sponsor ID: CPG / A105-0601-4
Conditions: Breast Augmentation, Breast Reconstruction, Breast Revision
Keywords: Breast Augmentation, Breast Reconstruction, Breast Revision, Silicone gel, Contour Profile Gel, Siltex®
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 955 participants (actual)
Lead sponsor: Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
Study start: Feb 2002
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 19 Dec 2008 (estimated)
Results: Posted 5 Apr 2016

Clinical summary

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

Detailed description

In September of 2000 the Core Gel study began, leading the way to the November 2006 FDA approval of the Core Gel implant or Memory Gel breast implant.

In June of 2013 the FDA approved MENTOR® MemoryShape™ Breast Implants (CPG Style 321 Medium Height, Moderate Profile) for the following indications:

Breast Augmentation for women at least 22 years old.
Breast Reconstruction.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Primary Augmentation	Other	Device: Mentor Siltex® Contour Profile Gel Mammary ProsthesisThe Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Primary Reconstruction	Other	Device: Mentor Siltex® Contour Profile Gel Mammary ProsthesisThe Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.
Revision Augmentation	Other	Device: Mentor Siltex® Contour Profile Gel Mammary ProsthesisThe Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.
Revision Reconstruction	Other	Device: Mentor Siltex® Contour Profile Gel Mammary ProsthesisThe Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject is genetic female, 18 years of age or older
A candidate for:
Signs the Informed Consent
Agrees to return device to Mentor if explant necessary
Agrees to comply with follow-up procedures, including returning for all follow-up visits

Key exclusion criteria (16 listed)

Subject is pregnant
Has nursed a child within three months of study enrollment
Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants)
Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)

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 Siltex® Contour Profile Gel Mammary ProsthesisThe MENTOR® MemoryShape™ Breast Implant is a silicone elastomer mammary device with a textured surface.	Device	Primary Augmentation, Primary Reconstruction, Revision Augmentation, Revision Reconstruction

Primary outcome

10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
Time frame: 10 years
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
Time frame: 10 years
Baker III was identified as "firm with visible distortion" and Baker IV was identified as "obvious spherical distortion". Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
Time frame: 10 years
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
Time frame: 10 years
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Overall Mean Change in Circumferential Chest Size
Time frame: Change from baseline to 10 years post-baseline
Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study

Results and safety

Results posted to the registry on 5 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Augmentation	572	327
Primary Reconstruction	190	101
Revision Augmentation	124	67
Revision Reconstruction	69	34

Primary outcome: 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation

Time frame: 10 years. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Primary Augmentation n = 572	Primary Reconstruction n = 190	Revision Augmentation n = 124	Revision Reconstruction n = 69
Value	22.3 (19.0 to 26.0)	52.7 (45.5 to 60.2)	35.0 (27.0 to 44.7)	59.7 (48.0 to 71.8)

Population analysed: All enrolled subjects are included.

Primary outcome: 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture

Time frame: 10 years. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Primary Augmentation n = 572	Primary Reconstruction n = 190	Revision Augmentation n = 124	Revision Reconstruction n = 69
Value	3.6 (2.3 to 5.7)	14.3 (9.6 to 21.1)	15.5 (9.8 to 24.1)	16.4 (9.1 to 28.5)

Population analysed: All enrolled subjects are included.

Primary outcome: 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection

Time frame: 10 years. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Primary Augmentation n = 572	Primary Reconstruction n = 190	Revision Augmentation n = 124	Revision Reconstruction n = 69
Value	0.7 (0.3 to 1.9)	1.6 (0.5 to 5.0)	1.9 (0.5 to 7.4)	2.9 (0.7 to 11.3)

Population analysed: All enrolled subjects are included.

Primary outcome: 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement

Time frame: 10 years. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Primary Augmentation n = 572	Primary Reconstruction n = 190	Revision Augmentation n = 124	Revision Reconstruction n = 69
Value	9.2 (7.0 to 12.0)	34.1 (27.6 to 41.7)	25.9 (18.7 to 35.2)	49.0 (37.6 to 61.8)

Population analysed: All enrolled subjects are included.

Adverse events

Time frame: Baseline (Surgery) to 10 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Augmentation	3 of 572 (0.5%)	91 of 572 (15.9%)	Not reported
Primary Reconstruction	10 of 190 (5.3%)	56 of 190 (29.5%)	Not reported
Revision Augmentation	3 of 124 (2.4%)	20 of 124 (16.1%)	Not reported
Revision Reconstruction	3 of 69 (4.3%)	37 of 69 (53.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25158767Caplin DA. Indications for the use of MemoryShape breast implants in aesthetic and reconstructive breast surgery: long-term clinical outcomes of shaped versus round silicone breast implants. Plast Reconstr Surg. 2014 Sep;134(3 Suppl):27S-37S. doi: 10.1097/PRS.0000000000000609.

Related trials for Breast Augmentation

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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.

William P Adams Jr, M.D. principal investigator

Dallas, TX

Dennis Hammond, M.D. principal investigator

Grand Rapids, MI

John Canady, M.D. study director

Mentor Worldwide, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mentor Siltex® Contour Profile Gel Mammary Prosthesis in people with Breast Augmentation and Breast Reconstruction, run by Mentor Worldwide, LLC at 1 site in United States.

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 8 inclusion and 16 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2016). 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?

10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation (time frame: 10 years). The study lists 5 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 NCT00812097, which also lists 1 linked publication.

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 5 Apr 2016.