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Spectra Breast Implant Study

Primary Purpose

Augmentation, Augmentation Revision, General Breast Enlargement

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Mentor Spectra/Becker 80 Breast Implant

About this trial

This is an interventional treatment trial for Augmentation focused on measuring Augmentation, Augmentation Revision

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mentor Worldwide LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Augmentation

Augmentation Revision

Arm Description

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.

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.

Outcomes

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.

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00981266

First Posted

July 28, 2009

Last Updated

February 27, 2013

Sponsor

Mentor Worldwide, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00981266

Brief Title

Spectra Breast Implant Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Business decision. Study never started

Study Start Date

June 2013 (undefined)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mentor Worldwide, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Augmentation, Augmentation Revision

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Augmentation

Arm Type

Other

Arm Description

Arm Title

Augmentation Revision

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Mentor Spectra/Becker 80 Breast Implant

Other Intervention Name(s)

Breast Implant, Double Lumen Breast-Implant, Becker 80 Implant, Spectra Implant

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

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

Time Frame

10 Years

Secondary Outcome Measure Information:

Title

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

Time Frame

10 Years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: