Recruitment

Recruitment Status
Completed
Estimated Enrollment
2000

Inclusion Criterias

A candidate for: Primary breast augmentation (general breast enlargement), Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry), or Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
Signs the Informed Consent
Subject is genetic female, 18 years of age or older
...
A candidate for: Primary breast augmentation (general breast enlargement), Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry), or Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
Signs the Informed Consent
Subject is genetic female, 18 years of age or older
Agrees to return device to Mentor if explant necessary
Agrees to comply with follow-up procedures, including returning for all follow-up visits

Exclusion Criterias

Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
Infection or abscess anywhere in the body
Subject in Augmentation cohort and has diagnosis of active cancer of any type. (Exception is low-grade non-metastasizing skin cancer)
...
Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
Infection or abscess anywhere in the body
Subject in Augmentation cohort and has diagnosis of active cancer of any type. (Exception is low-grade non-metastasizing skin cancer)
Premalignant breast disease without a subcutaneous mastectomy
Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants)
Are HIV positive
Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
Untreated or inappropriately treated breast malignancy, without mastectomy
Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
Subject is pregnant
Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
Work for Mentor or the study doctor or are directly-related to anyone that works for Mentor or the study doctor
Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
Has nursed a child within three months of study enrollment
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, spondylarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome

Summary

Conditions
  • Breast Augmentation
  • Breast Reconstruction
  • Breast Revision
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

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 pre-market a...

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 pre-market 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. In order to be implanted with gel-filled implants for augmentation, women had to be enrolled in an IDE clinical trial. In September of 2000 the Core Gel study began, leading the way to the November 2006 FDA approval of MemoryGel breast implant. The objective of the CPG Styles Study is to determine the safety of the different styles of Mentor's Contour Profile Gel (CPG) breast implants in women undergoing breast augmentation, reconstruction, or revision. Throughout the duration of this study, patients are required to have follow-up visits at 10 weeks post-surgery and every year after surgery through the 10th year of study completion. Total subject population: Up to 500 new subjects, plus up to 1500 subjects rolled over from the CPG Continued Access Study will continue the 10-year follow-up under this protocol. On September 10th, 2014, Mentor received FDA approval for the CPG Styles 312, 322, 323, and 332. The study is now closed to new subject enrollment.

Inclusion Criterias

A candidate for: Primary breast augmentation (general breast enlargement), Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry), or Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
Signs the Informed Consent
Subject is genetic female, 18 years of age or older
...
A candidate for: Primary breast augmentation (general breast enlargement), Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry), or Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
Signs the Informed Consent
Subject is genetic female, 18 years of age or older
Agrees to return device to Mentor if explant necessary
Agrees to comply with follow-up procedures, including returning for all follow-up visits

Exclusion Criterias

Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
Infection or abscess anywhere in the body
Subject in Augmentation cohort and has diagnosis of active cancer of any type. (Exception is low-grade non-metastasizing skin cancer)
...
Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
Infection or abscess anywhere in the body
Subject in Augmentation cohort and has diagnosis of active cancer of any type. (Exception is low-grade non-metastasizing skin cancer)
Premalignant breast disease without a subcutaneous mastectomy
Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants)
Are HIV positive
Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
Untreated or inappropriately treated breast malignancy, without mastectomy
Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
Subject is pregnant
Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
Work for Mentor or the study doctor or are directly-related to anyone that works for Mentor or the study doctor
Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
Has nursed a child within three months of study enrollment
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, spondylarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome

Locations

Santa Barbara, California, 93111
Santa Barbara, California, 93111

Tracking Information

NCT #
NCT01959880
Collaborators
Not Provided
Investigators
Study Director: John Canady, M.D. Mentor Worldwide, LLC