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Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction or Revision

Phase 3
18 Years
Open (Enrolling)
Breast Reconstruction, Breast Augmentation, Breast Revision

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Trial Information

Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction or Revision

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 Premarket 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 premarket 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 patients. Every patient implanted had to be part of an adjunct study, and had to
be offered participation in a registry of gel-filled breast implant patients. In order to
be implanted with gel-filled implants for augmentation, women had to be enrolled in a core
clinical study.

The objective of this study is to determine the safety and effectiveness of the smooth and
textured surface Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who
are undergoing primary breast augmentation, primary breast reconstruction or revision.

Inclusion Criteria:

- Subject is Genetic female and at least 18 years old

- A candidate for:

- Primary breast augmentation (for post-lactational mammary involution or general
breast enlargement)

- Primary breast reconstruction (for cancer, trauma, surgical loss of breast or
congenital deformity)

- Revision surgery (previous augmentation or reconstruction with silicone-filled or
saline-filled implants)

- Signs the Informed Consent

- Agrees to follow the procedures for explant analysis

- Agrees to comply with follow-up procedures, including returning for all follow-up

Exclusion Criteria:

- Patient 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, infections arthritis, spondylarthropathies, any
other inflammatory arthritis, osteoarthritis, fibromyalgia, or chronic fatigue

- Currently has a condition that could compromise or complicate wound healing (except
reconstruction patients)

- Patient in Augmentation cohort and has diagnosis of active cancer of any type

- Infection or abscess anywhere in the body

- Demonstrates tissue characteristics which are clinically incompatible with implant
(e.g. tissue damage resulting from radiation, inadequate tissue, or compromised

- 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

- 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

- Implanted metal or metal devices, history of claustrophobia or other condition that
would make a MRI scan prohibitive

Type of Study:


Study Design:

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

Outcome Measure:

Safety will be determined by the incidence, severity, method of resolution, and duration for all adverse events on a per implant and a per patient basis.

Outcome Time Frame:

10 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2000

Completion Date:

December 2012

Related Keywords:

  • Breast Reconstruction
  • Breast Augmentation
  • Breast Revision
  • Breast Reconstruction
  • Breast Augmentation
  • Revision
  • Silicone breast implants
  • Round low-bleed



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