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

NCT ID: NCT00753922

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1008 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2012-06-30

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary Augmentation

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

Group Type: OTHER

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

Intervention Type: 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 Reconstruction

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.

Group Type: OTHER

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

Intervention Type: 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.

Revison Augmentation

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.

Group Type: OTHER

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

Intervention Type: 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.

Revision Reconstruction

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mentor Worldwide, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mentor Worldwide, LLC

Santa Barbara, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33620918 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25158767 (View on PubMed)

Related Links

http://www.mentorwwllc.com/global-us/

Related Info

Other Identifiers

10-009-0799-01

Identifier Type: -

Identifier Source: org_study_id