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Spectra Breast Implant Study

This study has been withdrawn prior to enrollment.
(Business decision. Study never started)
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT00981266
First received: July 28, 2009
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Augmentation
Augmentation Revision
General Breast Enlargement
Post-lactational Involution
Asymmetry
Device: Mentor Spectra/Becker 80 Breast Implant
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mentor Worldwide, LLC:

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. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Effectiveness will be determined by changes in chest circumference and bra and cup size. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness will also be determined by changes in validated Quality of Life instrument ratios. [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: October 2026
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Augmentation

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
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.
Other Names:
  • Breast Implant
  • Double Lumen Breast-Implant
  • Becker 80 Implant
  • Spectra Implant
Augmentation Revision

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
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.
Other Names:
  • Breast Implant
  • Double Lumen Breast-Implant
  • Becker 80 Implant
  • Spectra Implant

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.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981266

Locations
United States, California
Mentor Worldwide LLC
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
Mentor Worldwide, LLC
Investigators
Principal Investigator: 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
Study Director: Neal Handel, M.D. Medical Director - Sherman Oaks, CA
Principal Investigator: 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
  More Information

Additional Information:
Publications:
Jakubietz, M.G., et al. 2004. Breast augmentation: Cancer concerns and mammography - A literature review. Plast. Reconstr. Surg. 113:117e 122e.
McLaughlin, J.K. and L. Lipworth. 2004. Brain cancer and cosmetic breast implants: A review of the epidemiological evidence. Ann. Plast. Surg. 52(2):15-17.
Stein, J., et al. 1999. In situ determination of the active catalyst in hydrosilylation reactions using highly reactive Pt(0) catalyst precursors. J. Am. Chem. Soc. 121(15):3693-3703
Chandra, G., et al. 1987. A convenient and novel route to bis(alkyne)platinum(0) and other platinum(0) complexes from Speier's hydrosilylation catalyst. Organometallics. 6:191-2
Lappert, M.F. and Scott, F.P.A. 1995. The reaction pathway from Speier's to Karstedt's hydrosilylation catalyst. J. Organomet. Chem. 492(2):C11-C13
Lewis, L.N., et al. 1995. Mechanism of formation of platinum(0) complexes containing silicon-vinyl ligands. Organometallics. 14:2202-13

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00981266     History of Changes
Other Study ID Numbers: A101-0501-10
Study First Received: July 28, 2009
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mentor Worldwide, LLC:
Augmentation
Augmentation Revision

ClinicalTrials.gov processed this record on November 20, 2014