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NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study | Clinical Trials | Clareo Health

TERMINATEDNA

NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study

NCT01870869•Allergan

Summary

This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants for breast augmentation, reconstruction, or revision.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Female, age 18 or older (age 22 or older for breast augmentation participants who are implanted under Protocol 410CAXL-001)
•Present with 1 or more of the following conditions:
•* Primary breast augmentation (i.e., no previous breast implant surgery) indicated for participant dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
•* Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma, (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when permanent implants are placed in the reconstructed breast)
•* Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants
•Has adequate tissue available to cover implants

Exclusion Criteria

•Has an advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
•Has an existing carcinoma of the breast, without mastectomy
•Has an abscess or infection in the body at the time of enrollment
•Is pregnant or nursing
•Has any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) \> 8%), that is clinically known to impact wound healing ability
•Shows tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration
•Has or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
•Shows psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
•Is not willing to undergo further surgery for revision, if medically required

Locations (58)

Anthony Griffin

Beverly Hills, California, United States

Laurence Berkowitz

Campbell, California, United States

Mary Powers

Long Beach, California, United States

Roy Hong

Palo Alto, California, United States

Eric Bachelor

Pleasanton, California, United States

Douglas Reavie

San Diego, California, United States

Steven Teitelbaum

Santa Monica, California, United States

Tad Heinz

Colorado Springs, Colorado, United States

Gary Snider

Denver, Colorado, United States

Terrence Murphy

Englewood, Colorado, United States

Key Dates

Start Date

May 29, 2013

Primary Completion Date

November 30, 2015

Completion Date

November 30, 2015

Last Updated

June 22, 2020

Enrollment

1,951

ACTUAL participants

Conditions

Breast AugmentationBreast ReconstructionBreast Implant Revision

Interventions

Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection

DEVICE

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DIEP Flap Breast Reconstruction

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RECRUITINGNA

Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

NCT06556654

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A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study

Inclusion Criteria

Exclusion Criteria

Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest

Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

AFT: Introduction of a Full Breast Reconstructive Method

Endoscopic Nipple-Sparing Mastectomy (E-NSM) With Immediate Multistage Autologous Fat Grafting(IMAFG) for Total Breast Reconstruction Via the Axillary Incision