Study of the Safety and Effectiveness of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction
18 Years
N/A
Female
Breast Reconstruction
Trial Information
Study of the Safety and Effectiveness of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
10 years
Safety Issue:
Yes
Principal Investigator
Alexander Digenis, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical Director
Authority:
United States: Food and Drug Administration
Study ID:
A-101-0501-8
NCT ID:
NCT00750685
Start Date:
March 2007
Completion Date:
September 2019
Related Keywords:
- Breast Reconstruction
- Primary Breast Reconstruction
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