Study of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction

NCT00750685 | Terminated Phase 3

• 2 other identifiers: A-101-0501-8Becker Study
• Study Type: interventional
• Target: 315
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the Becker Expander/Breast Implant in women who are undergoing primary breast reconstruction. Safety information on the rate of complications, such as infection will be collected, and used to help determine device safety. These implants are investigational devices. Approximately 300 patients at centers across the United States will be enrolled in this research study, by up to 30 sites. These patients will be implanted with Becker Expander/Breast Implant 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

Keywords

Primary Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• Safety will be determined by the incidence, severity, method of resolution, and duration for all adverse events on a per implant and per subject basis.

  10 years

• Effectiveness will be determined by changes in chest circumference and bra and cup size.

  10 years

Secondary Outcomes (1)

• Effectiveness will also be determined by changes in validated Quality of Life instrument ratios.

  10 years

Study Arms (1)

Reconstruction

OTHER

The study population will consist of women aged 18 or over who are undergoing primary breast reconstruction. The Reconstruction cohort will include subjects with loss of breast tissue due to mastectomy, contralateral breast for post-reconstruction symmetry or subjects with deformities secondary to disease, malignancy, trauma, and congenital deformity. Subjects in this cohort cannot have been implanted with breast implants, but may have tissue expanders. A Becker implant is considered a tissue expander until the port and fill tube have been removed. Women who undergo surgery primarily for a mastopexy will not be part of the reconstruction cohort.

Device: Mentor Smooth Becker 50 Expander/Breast Implant

Interventions

Mentor Smooth Becker 50 Expander/Breast Implant DEVICE

The Mentor Becker Expander/Breast Implant is comprised of two components: the Becker implant and the injection dome/fill tube. The breast implant is available in a smooth surface. It has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The silicone elastomer fill tube is pre-inserted into the dual self-sealing valve system at the time of manufacture and is joined to the injection dome by the connector system at the time of surgery. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.

Also known as: Breast Implant, Double-Lumen Breast Implant, Becker Implant

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 reconstruction for cancer, trauma, surgical loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, or congenital deformity, including asymmetry
• 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, spondylarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
• Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
• 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

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead

MeSH Terms

Interventions

Breast Implants

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Janet Vargo

  Mentor Worldwide, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: March 1, 2007
• Primary Completion: March 4, 2014
• Study Completion: March 4, 2014
• Last Updated: May 8, 2018

Record last verified: 2018-05