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Search / Trial NCT00981266

Spectra Breast Implant Study

Launched by MENTOR WORLDWIDE, LLC · Sep 18, 2009

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Trial Information

Current as of April 25, 2025

Withdrawn

Keywords

Augmentation Augmentation Revision

ClinConnect Summary

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...

Gender

FEMALE

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

Trial Officials

Kaveh Alizadeh, M.D.

Principal Investigator

Garden City, NY

Joseph Bauer, M.D.

Principal Investigator

Alpharetta, GA

Steven P. Bloch, M.D.

Principal Investigator

Highland Park, IL

William R. Burden, M.D.

Principal Investigator

Destin, FL

David Caplin, M.D.

Principal Investigator

St. Louis, MO

Michael Cohen, M.D.

Principal Investigator

Towson, MD

Steven Gitt, M.D.

Principal Investigator

Phoenix, AZ

Mike E. Gonce, M.D.

Principal Investigator

Oklahoma City, OK

Lawrence Gray, M.D.

Principal Investigator

Portsmouth, NH

John Grossman, M.D.

Principal Investigator

Denver, CO

W. Tracy Hankins, M.D.

Principal Investigator

Lake Havasu City, AZ & Las Vegas, NV

Lars Enevoldsen, M.D.

Principal Investigator

Modesto, CA

Neal Handel, M.D.

Study Director

Medical Director - Sherman Oaks, CA

Jason Pozner, M.D.

Principal Investigator

Boca Raton, FL

Cayce Rumsey, M.D.

Principal Investigator

Ponte Vedra Beach, FL

Kimberly Short, M.D.

Principal Investigator

Indianapolis, IN

Paul Silverstein, M.D.

Principal Investigator

Oklahoma City, OK

Jon Trevisani, M.D.

Principal Investigator

Maitland, FL

Douglas Wagner, M.D.

Principal Investigator

Akron, OH

Simeon Wall Jr., M.D.

Principal Investigator

Shreveport, LA

Wesley Wilson, M.D.

Principal Investigator

Scottsdale, AZ

Richard Zienowicz, M.D.

Principal Investigator

Providence, RI

Hilton Becker, MD

Principal Investigator

Boca Raton, FL

William Hedden, MD

Principal Investigator

Birmingham, AL

Jorge Perez, MD

Principal Investigator

Fort Lauderdale, FL

Marc Salzman, MD

Principal Investigator

Louisville, KY

About Mentor Worldwide, Llc

Mentor Worldwide LLC is a leading global medical device company specializing in innovative aesthetic and reconstructive solutions. A subsidiary of Johnson & Johnson, Mentor is dedicated to advancing patient care through the development of high-quality breast implants and other surgical products. With a strong commitment to clinical research and compliance with regulatory standards, Mentor Worldwide actively sponsors clinical trials aimed at enhancing the safety and efficacy of its offerings, thereby fostering ongoing improvements in patient outcomes and satisfaction in the fields of plastic and reconstructive surgery.

Locations

Santa Barbara, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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