Spectra Breast Implant Study

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

Interventions

DEVICE

Mentor Spectra/Becker 80 Breast Implant

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.

Sponsors & Collaborators

• Mentor Worldwide, LLC

  lead INDUSTRY

Principal Investigators

• Kaveh Alizadeh, M.D. · Garden City, NY

• Joseph Bauer, M.D. · Alpharetta, GA

• Steven P. Bloch, M.D. · Highland Park, IL

• William R. Burden, M.D. · Destin, FL

• David Caplin, M.D. · St. Louis, MO

• Michael Cohen, M.D. · Towson, MD

• Steven Gitt, M.D. · Phoenix, AZ

• Mike E. Gonce, M.D. · Oklahoma City, OK

• Lawrence Gray, M.D. · Portsmouth, NH

• John Grossman, M.D. · Denver, CO

• W. Tracy Hankins, M.D. · Lake Havasu City, AZ & Las Vegas, NV

• Lars Enevoldsen, M.D. · Modesto, CA

• Neal Handel, M.D. · Medical Director - Sherman Oaks, CA

• Jason Pozner, M.D. · Boca Raton, FL

• Cayce Rumsey, M.D. · Ponte Vedra Beach, FL

• Kimberly Short, M.D. · Indianapolis, IN

• Paul Silverstein, M.D. · Oklahoma City, OK

• Jon Trevisani, M.D. · Maitland, FL

• Douglas Wagner, M.D. · Akron, OH

• Simeon Wall Jr., M.D. · Shreveport, LA

• Wesley Wilson, M.D. · Scottsdale, AZ

• Richard Zienowicz, M.D. · Providence, RI

• Hilton Becker, MD · Boca Raton, FL

• William Hedden, MD · Birmingham, AL

• Jorge Perez, MD · Fort Lauderdale, FL

• Marc Salzman, MD · Louisville, KY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

22 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2024-01-31

Completion

2026-10-31

Countries

• United States

Study Locations