Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84329 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2012-12-31

Brief Summary

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Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.

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Detailed Description

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Conditions

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Breast Reconstruction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Primary reconstruction

Group Type EXPERIMENTAL

Natrelle(TM) Silicone-Filled Breast Implants

Intervention Type DEVICE

Breast implant surgery

2

Revision-reconstruction

Group Type EXPERIMENTAL

Natrelle(TM) Silicone-Filled Breast Implants

Intervention Type DEVICE

Breast implant surgery

3

Revision-augmentation

Group Type EXPERIMENTAL

Natrelle(TM) Silicone-Filled Breast Implants

Intervention Type DEVICE

Breast implant surgery

Interventions

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Natrelle(TM) Silicone-Filled Breast Implants

Breast implant surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
* Females seeking revision augmentation or revision reconstruction, where problems exist
* Have any of the following conditions or situations present:
* Post mastectomy surgical removal of the breast for cancer or other disease;
* Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
* Severe ptosis requiring reconstruction;
* Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
* Adequate tissue available to cover implants.
* Saline-filled implants are not an appropriate choice.

Exclusion Criteria

* Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
* Existing carcinoma of the breast, without mastectomy.
* Abscess of infection in the body at the time of enrollment.
* Pregnant or nursing.
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
* Show tissue characteristics which are clinically incompatible with mammaplasty.
* Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
* Are not willing to undergo further surgery for revision, if medically required.
* Diagnosis of lupus or scleroderma.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes