Spectra Breast Implant Study

NCT00981266 | Withdrawn Phase 3

• 1 other identifier: A101-0501-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Augmentation; Augmentation Revision

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  10 Years

Study Arms (2)

Augmentation

OTHER

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

Augmentation Revision

OTHER

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

Interventions

Mentor Spectra/Becker 80 Breast Implant DEVICE

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.

Also known as: Breast Implant, Double Lumen Breast-Implant, Becker 80 Implant, Spectra Implant

Augmentation; Augmentation Revision

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead

Study Sites (1)

Mentor Worldwide LLC

Santa Barbara, California, 93111, United States

Location

Related Publications (39)

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  BACKGROUND

MeSH Terms

Interventions

Breast Implants

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Kaveh Alizadeh, M.D.

  Garden City, NY

  PRINCIPAL INVESTIGATOR

• Joseph Bauer, M.D.

  Alpharetta, GA

  PRINCIPAL INVESTIGATOR

• Steven P. Bloch, M.D.

  Highland Park, IL

  PRINCIPAL INVESTIGATOR

• William R. Burden, M.D.

  Destin, FL

  PRINCIPAL INVESTIGATOR

• David Caplin, M.D.

  St. Louis, MO

  PRINCIPAL INVESTIGATOR

• Michael Cohen, M.D.

  Towson, MD

  PRINCIPAL INVESTIGATOR

• Steven Gitt, M.D.

  Phoenix, AZ

  PRINCIPAL INVESTIGATOR

• Mike E. Gonce, M.D.

  Oklahoma City, OK

  PRINCIPAL INVESTIGATOR

• Lawrence Gray, M.D.

  Portsmouth, NH

  PRINCIPAL INVESTIGATOR

• John Grossman, M.D.

  Denver, CO

  PRINCIPAL INVESTIGATOR

• W. Tracy Hankins, M.D.

  Lake Havasu City, AZ & Las Vegas, NV

  PRINCIPAL INVESTIGATOR

• Lars Enevoldsen, M.D.

  Modesto, CA

  PRINCIPAL INVESTIGATOR

• Neal Handel, M.D.

  Medical Director - Sherman Oaks, CA

  STUDY DIRECTOR

• Jason Pozner, M.D.

  Boca Raton, FL

  PRINCIPAL INVESTIGATOR

• Cayce Rumsey, M.D.

  Ponte Vedra Beach, FL

  PRINCIPAL INVESTIGATOR

• Kimberly Short, M.D.

  Indianapolis, IN

  PRINCIPAL INVESTIGATOR

• Paul Silverstein, M.D.

  Oklahoma City, OK

  PRINCIPAL INVESTIGATOR

• Jon Trevisani, M.D.

  Maitland, FL

  PRINCIPAL INVESTIGATOR

• Douglas Wagner, M.D.

  Akron, OH

  PRINCIPAL INVESTIGATOR

• Simeon Wall Jr., M.D.

  Shreveport, LA

  PRINCIPAL INVESTIGATOR

• Wesley Wilson, M.D.

  Scottsdale, AZ

  PRINCIPAL INVESTIGATOR

• Richard Zienowicz, M.D.

  Providence, RI

  PRINCIPAL INVESTIGATOR

• Hilton Becker, MD

  Boca Raton, FL

  PRINCIPAL INVESTIGATOR

• William Hedden, MD

  Birmingham, AL

  PRINCIPAL INVESTIGATOR

• Jorge Perez, MD

  Fort Lauderdale, FL

  PRINCIPAL INVESTIGATOR

• Marc Salzman, MD

  Louisville, KY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: September 22, 2009
• Study Start: June 1, 2013
• Primary Completion: January 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

US (1)