Status:
TERMINATED
Study of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction
Lead Sponsor:
Mentor Worldwide, LLC
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 o...
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 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2014
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT00750685
Start Date
March 1 2007
End Date
March 4 2014
Last Update
May 8 2018
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