Breast ReconstructionPhase 3NCT00753922

Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses

A Phase 3 study testing Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface in people with Breast Reconstruction and Breast Augmentation, 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 Reconstruction, Breast Augmentation, Breast Revision
What is being tested?: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,008 participants
Where: 1 siteUnited States
Study dates: Sep 2000to Jun 2012
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 and at least 18 years old
A candidate for:
Primary breast augmentation (for post-lactational mammary involution or general breast enlargement)
Primary breast reconstruction (for cancer, trauma, surgical loss of breast or congenital deformity)
Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
Signs the Informed Consent
Agrees to follow the procedures for explant analysis
Agrees to comply with follow-up procedures, including returning for all follow-up visits

Who cannot join

Patient 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, infections arthritis, spondylarthropathies, any other inflammatory arthritis, osteoarthritis, fibromyalgia, or chronic fatigue syndrome
Currently has a condition that could compromise or complicate wound healing (except reconstruction patients)
Patient in Augmentation cohort and has diagnosis of active cancer of any type

Show all 14Show 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
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: Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction or Revision

The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled 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 centers across the United States will be enrolled in this research study. These patients will be implanted with silicone breast prostheses and 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.

The objective of this study is to determine the safety and effectiveness of the smooth and textured surface Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary breast augmentation, primary breast reconstruction or revision.

Conditions: Breast Reconstruction, Breast Augmentation, Breast Revision
Being tested: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Keywords: Breast Reconstruction, Breast Augmentation, Revision, Silicone breast implants, Round low-bleed

What participants receive

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

Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth SurfaceDevice
Two types of Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses will be used in the study: the Siltex textured surface device and the smooth surface device. Each implant is a silicone elastomer (rubber) mammary device that is supplied individually packaged in a doubled wrapped packaging system, sterile, and non-pyrogenic (does not cause fever). Each device consists of a silicone shell encasing a silicone gel filler material with a patch on the posterior side of the device. The basic smooth device shell consists of a silicone layer sandwiched in between two other silicone layers. This construction acts as a barrier to slow the diffusion of (spread) any gel filler materials through the shell. The Siltex textured shell consists of a smooth shell to which is bonded an additional layer of silicone with a textured pattern imprinted into its surface. The Siltex shell is intended to prevent tissue ingrowth. The implants will be available in sizes 100cc through 800ccs.

Study groups in NCT00753922
Study group	Role	What they receive
Primary Augmentation	Other	The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement. Receives: Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Primary Reconstruction	Other	The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity. Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry. Receives: Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Revison Augmentation	Other	Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery. Receives: Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Revision Reconstruction	Other	Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery. Receives: Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface

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
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
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

Timeline

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

Sep 2000Jun 2012

First posted17 Sep 2008 (estimated)
Study startSep 2000
Primary completionJun 2012
Study completionJun 2012

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 (2)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,008 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00753922
Sponsor's protocol ID: 10-009-0799-01
Status last verified: Mar 2014
First submitted: 15 Sep 2008
Last updated: 16 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

Publications

Caplin DA, Calobrace MB, Wixtrom RN, Estes MM, Canady JW. MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up. Plast Reconstr Surg. 2021 Mar 1;147(3):556-566. doi: 10.1097/PRS.0000000000007635.
PubMed 33620918
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 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction or Revision
ClinicalTrials.gov ID: NCT00753922
Acronym / sponsor ID: 10-009-0799-01
Conditions: Breast Reconstruction, Breast Augmentation, Breast Revision
Keywords: Breast Reconstruction, Breast Augmentation, Revision, Silicone breast implants, Round low-bleed
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,008 participants (actual)
Lead sponsor: Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
Study start: Sep 2000
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 17 Sep 2008 (estimated)
Results: Posted 23 Aug 2013

Clinical summary

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

Detailed description

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 Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth SurfaceThe Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
Primary Reconstruction	Other	Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth SurfaceThe Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity. Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.
Revison Augmentation	Other	Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth SurfacePatients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
Revision Reconstruction	Other	Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth SurfacePatients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous 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 and at least 18 years old
A candidate for:
Primary breast augmentation (for post-lactational mammary involution or general breast enlargement)
Primary breast reconstruction (for cancer, trauma, surgical loss of breast or congenital deformity)
Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)

Key exclusion criteria (14 listed)

Patient 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, infections arthritis, spondylarthropathies, any other inflammatory arthritis, osteoarthritis, fibromyalgia, or chronic fatigue syndrome
Currently has a condition that could compromise or complicate wound healing (except reconstruction patients)

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 Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth SurfaceTwo types of Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses will be used in the study: the Siltex textured surface device and the smooth surface device. Each implant is a silicone elastomer (rubber) mammary device that is supplied individually packaged in a doubled wrapped packaging system, sterile, and non-pyrogenic (does not cause fever). Each device consists of a silicone shell encasing a silicone gel filler material with a patch on the posterior side of the device. The basic smooth device shell consists of a silicone layer sandwiched in between two other silicone layers. This construction acts as a barrier to slow the diffusion of (spread) any gel filler materials through the shell. The Siltex textured shell consists of a smooth shell to which is bonded an additional layer of silicone with a textured pattern imprinted into its surface. The Siltex shell is intended to prevent tissue ingrowth. The implants will be available in sizes 100cc through 800ccs.	Device	Primary Augmentation, Primary Reconstruction, Revision Reconstruction, Revison Augmentation

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.
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
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.

Results and safety

Results posted to the registry on 23 Aug 2013, 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	552	306
Primary Reconstruction	251	157
Revision Augmentation	145	82
Revision Reconstruction	60	37

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 = 552	Primary Reconstruction n = 251	Revison Augmentation n = 145	Revision Reconstruction n = 60
Value	25.5 (21.9 to 29.5)	49.0 (42.6 to 55.7)	43.6 (35.8 to 52.4)	50.7 (38.7 to 64.0)

Population analysed: All enrolled subjects are included

Primary outcome: Overall Mean Change in Circumferential Chest Size

Time frame: Change from baseline to 10 years post-baseline. Mean (Standard Deviation). Unit: centimeters

Measure	Primary Augmentation n = 552	Primary Reconstruction n = 251	Revison Augmentation n = 145	Revision Reconstruction n = 60
Value	7.45 (4.50)	4.88 (7.25)	2.89 (4.56)	4.18 (5.68)

Population analysed: All enrolled subjects

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 = 552	Primary Reconstruction n = 251	Revison Augmentation n = 145	Revision Reconstruction n = 60
Value	12.1 (9.6 to 15.2)	20.5 (15.5 to 26.7)	24.4 (18.1 to 32.5)	36.9 (25.0 to 52.2)

Population analysed: All enrolled subjects

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 = 552	Primary Reconstruction n = 251	Revison Augmentation n = 145	Revision Reconstruction n = 60
Value	1.6 (0.9 to 3.1)	6.2 (3.8 to 10.1)	1.4 (0.4 to 5.5)	0.0 (NA to NA)

Population analysed: All enrolled subjects

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Primary Augmentation	0 of 552 (0%)	0 of 552 (0%)	Not reported
Primary Reconstruction	0 of 251 (0%)	0 of 251 (0%)	Not reported
Revison Augmentation	0 of 145 (0%)	0 of 145 (0%)	Not reported
Revision Reconstruction	0 of 60 (0%)	0 of 60 (0%)	Not reported

Limitations and caveats (from the sponsor): Adverse events were not coded according to the MedDRA dictionary, rather they were collected as Complications in alignment with the 2006 FDA Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33620918Caplin DA, Calobrace MB, Wixtrom RN, Estes MM, Canady JW. MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up. Plast Reconstr Surg. 2021 Mar 1;147(3):556-566. doi: 10.1097/PRS.0000000000007635.
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.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 14 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 16 Apr 2014. 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 23 Aug 2013). 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 NCT00753922, which also lists 2 linked publications.

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 16 Apr 2014.