Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

715 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2011-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Breast Augmentation Breast Reconstruction Revision of Augmentation or 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 augmentation

Group Type EXPERIMENTAL

Natrelle(TM) Silicone-Filled Breast Implants

Intervention Type DEVICE

Breast implant surgery

2

Primary 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

4

Revision-reconstruction

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

* Female, age 18 years or older
* Seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia, asymmetry, ptosis, or aplasia
* Seeking primary breast reconstruction
* Seeking breast revision-augmentation
* Seeking breast revision-reconstruction
* Adequate tissue available to cover implants
* Patients at MRI designated sites must be willing to undergo MRI at their 1,3, 5, 7 and 9-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).

Exclusion Criteria

* Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
* Existing carcinoma of the breast, without mastectomy
* Abscess or infection in the body at the time of enrollment
* Pregnant or nursing
* Have any disease, including uncontrolled diabetes (e.g., HbAIc \> 8%), that is clinically known to impact wound healing ability
* Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration
* Have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
* Show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
* Are not willing to undergo further surgery for revision, if medically required

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes