Spectra Breast Implant Study

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation. 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 450 patients at sites across the United States will be enrolled in this research study by up to 30 sites. These patients will be implanted with Spectra/Becker 80 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.

Detailed Description
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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. The Adjunct Study devices included the round MemoryGel, Becker Expander/Prosthesis and the Lumera implants. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in an Investigational Device Exemption (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 or any Adjustable Gel-Filled implants. The Spectra/Becker 80 Adjustable Breast Implants were not included in the Adjunct Study. This study is designed to study the safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants for primary breast augmentation or augmentation revision.

Official Title
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Study of the Safety and Effectiveness of the Mentor Spectra/Becker 80 Adjustable Breast Implant in Subjects Who Are Undergoing Primary Augmentation or Augmentation Revision

Conditions
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Asymmetry, Augmentation, Augmentation Revision, General Breast Enlargement, Post-lactational Involution

Intervention / Treatment
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* Device: Mentor Spectra/Becker 80 Breast Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is genetic female and is at least 22-years-old A candidate for primary breast augmentation (general breast enlargement, post-lactational involution, asymmetry) or augmentation revision (previous augmentation 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 Patient is a US citizen with a Social Security Number 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, spondyarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome Currently has a condition that could compromise or complicate wound healing Has diagnosis of active cancer of any type Infection or abscess anywhere in the body Demonstrates tissue characteristics which are clinically incompatible with implant placement (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 physician(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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Augmentation<br>The study population will consist of women aged 22 or over who are undergoing primary breast augmentation. The Augmentation cohort will include candidates for general breast enlargement, post-lactational involution and/or asymmetry. | Device: Mentor Spectra/Becker 80 Breast Implant<br>* The Mentor Smooth Spectra/Becker 80 Adjustable Breast Implant has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over a period of time via the fill tube by injecting saline through the injection dome. Once filled to the desired volume, the fill tube and injection dome are removed, and the prosthesis remains in position as a breast implant. Its purpose is to provide volume flexibility and projection adjustability.<br>* Other names: Spectra Implant;|
| Other: Augmentation Revision<br>The study population will consist of women aged 22 or over who are undergoing augmentation revision. The Augmentation Revision cohort will include candidates with previous augmentation with silicone-filled or saline-filled implants. | Device: Mentor Spectra/Becker 80 Breast Implant<br>* The Mentor Smooth Spectra/Becker 80 Adjustable Breast Implant has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over a period of time via the fill tube by injecting saline through the injection dome. Once filled to the desired volume, the fill tube and injection dome are removed, and the prosthesis remains in position as a breast implant. Its purpose is to provide volume flexibility and projection adjustability.<br>* Other names: Spectra Implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness will also be determined by changes in validated Quality of Life instrument ratios. |  | 10 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmentation, Augmentation Revision