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

NCT00753922 | Completed Phase 3 Results

• 1 other identifier: 10-009-0799-01
• Study Type: interventional
• Target: 1,008
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Reconstruction; Breast Augmentation; Breast Revision

Keywords

Breast Reconstruction; Breast Augmentation; Revision; Silicone breast implants; Round low-bleed

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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.

  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.

  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.

  10 Years

Study Arms (4)

Primary Augmentation

OTHER

The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.

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.

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.

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.

Device: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface

Interventions

Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface DEVICE

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.

Primary Augmentation; Primary Reconstruction; Revision Reconstruction; Revison Augmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead

Study Sites (1)

Mentor Worldwide, LLC

Santa Barbara, California, 93111, United States

Location

Related Publications (2)

• 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.

  PMID: 33620918 DERIVED

• 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.

  PMID: 25158767 DERIVED

Related Links

• Related Info

Limitations and Caveats

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.

Results Point of Contact

• Title: Michael L. Schwiers
• Organization: Ethicon Endo-Surgery

mschwier@its.jnj.com

513-337-1172

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 17, 2008
• Study Start: September 1, 2000
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 16, 2014
• Results First Posted: August 23, 2013

Record last verified: 2014-03

Locations

US (1)