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

This study has been terminated.
(Sponsor Terminated)
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT00750685
First received: September 9, 2008
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Breast Reconstruction
Device: Mentor Smooth Becker 50 Expander/Breast Implant
Phase 3

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Safety and Effectiveness of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Mentor Worldwide, LLC:

Primary Outcome Measures:
  • 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. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Effectiveness will be determined by changes in chest circumference and bra and cup size. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness will also be determined by changes in validated Quality of Life instrument ratios. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 315
Study Start Date: March 2007
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Reconstruction

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
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.
Other Names:
  • Breast Implant
  • Double-Lumen Breast Implant
  • Becker Implant

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 Pre-market 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 pre-market 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 subjects. Every subject implanted had to be part of an adjunct study, in addition to being offered participation in a registry of gel-filled breast implant subjects. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in an IDE clinical trial.

A PMA for Mentor's MemoryGel™ Silicone Gel-Filled breast implants (which did not include the Becker Expander/Breast Implants) was subsequently filed with FDA in December 2003, and approved in November 2006 (P030053). As a condition of approval of P030053, new enrollment in Mentor's Adjunct Study has ceased, and women no longer have access to the Becker Expander/Breast Implants.

This study is designed to evaluate the safety and effectiveness of Mentor's Becker Expander/Breast Implants for primary breast reconstruction

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be allowed to enter the study if the following inclusion criteria are met:

  • 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

Exclusion Criteria:

Patients will not be allowed to enter the study if they have any of the following exclusion criteria:

  • 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
  • Surgeon intending to use the device for tissue expansion only
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750685

Sponsors and Collaborators
Mentor Worldwide, LLC
Investigators
Study Director: Janet Vargo Mentor Worldwide, LLC
  More Information

No publications provided

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00750685     History of Changes
Other Study ID Numbers: A-101-0501-8, Becker Study
Study First Received: September 9, 2008
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mentor Worldwide, LLC:
Primary Breast Reconstruction

ClinicalTrials.gov processed this record on October 20, 2014