Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial

NCT00812097 | Completed Phase 3 Results

• 1 other identifier: A105-0601-4
• Study Type: interventional
• Target: 955
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Augmentation; Breast Reconstruction; Breast Revision

Keywords

Breast Augmentation; Breast Reconstruction; Breast Revision; Silicone gel; Contour Profile Gel; Siltex®

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

• 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

• 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

Study Arms (4)

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.

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.

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.

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.

Device: Mentor Siltex® Contour Profile Gel Mammary Prosthesis

Interventions

Mentor Siltex® Contour Profile Gel Mammary Prosthesis DEVICE

The MENTOR® MemoryShape™ Breast Implant is a silicone elastomer mammary device with a textured surface.

Primary Augmentation; Primary Reconstruction; Revision Augmentation; Revision Reconstruction

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, 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead

Study Sites (1)

Mentor Worldwide, LLC

Santa Barbara, California, 93111, United States

Location

Related Publications (1)

• 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

Results Point of Contact

• Title: Michael Schwiers
• Organization: Mentor

mschwier@its.jnj.com

513-337-1172

Study Officials

• William P Adams Jr, M.D.

  Dallas, TX

  PRINCIPAL INVESTIGATOR

• Dennis Hammond, M.D.

  Grand Rapids, MI

  PRINCIPAL INVESTIGATOR

• John Canady, M.D.

  Mentor Worldwide, LLC

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 19, 2008
• Study Start: February 1, 2002
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 5, 2016
• Results First Posted: April 5, 2016

Record last verified: 2016-03

Locations

US (1)