Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
NCT ID: NCT01785069
Last Updated: 2020-06-25
Study Results
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View full resultsBasic Information
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TERMINATED
NA
355 participants
INTERVENTIONAL
2012-12-10
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Augmentation
Women who had breast augmentation with NATRELLE® 410 implants.
Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Surgical implant
Reconstruction
Women who had breast reconstruction with NATRELLE® 410 implants.
Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Surgical implant
Revision-Augmentation
Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Surgical implant
Revision-Reconstruction
Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Surgical implant
Interventions
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Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Surgical implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Present with 1 or more of the following conditions:
1. Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
2. 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 the permanent implants are placed in the reconstructed breast)
3. 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
* Willing to undergo magnetic resonance imaging (MRI) at the specified follow-up visits for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)
Exclusion Criteria
* Does not have existing carcinoma of the breast, without mastectomy
* Does not have abscess or infection in the body at the time of enrollment
* Is not pregnant or nursing
* Does not have any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) \> 8%), that is clinically known to impact wound healing ability
* Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation inadequate tissue, compromised vascularity, or ulceration
* Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
* Does not 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)
* Is not willing to undergo further surgery for revision, if medically required
18 Years
FEMALE
Yes
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Schumacher
Role: STUDY_CHAIR
Allergan
Locations
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Laurence Berkowitz
Campbell, California, United States
Roy Hong
Palo Alto, California, United States
Eric Bachelor
Pleasanton, California, United States
Gregory Liebscher
Colorado Springs, Colorado, United States
Scott Spear
Washington D.C., District of Columbia, United States
Calvin Peters
Orlando, Florida, United States
Walter Erhardt
Albany, Georgia, United States
James Namnoum
Atlanta, Georgia, United States
Janet Turkle
Carmel, Indiana, United States
Julene Samuels
Louisville, Kentucky, United States
Timothy Mickel
Monroe, Louisiana, United States
John Renucci
Grand Rapids, Michigan, United States
Steven Morris
Midland, Michigan, United States
Charles Nathan
Chesterfield, Missouri, United States
Herluf Jr. Lund
Chesterfield, Missouri, United States
Patricia McGuire
Creve Coeur, Missouri, United States
Perry Johnson
Omaha, Nebraska, United States
Peter Hyans
Berkeley Heights, New Jersey, United States
Peter Hetzler
Little Silver, New Jersey, United States
Caroline Glicksman
Sea Girt, New Jersey, United States
Tracy Pfeifer
Great Neck, New York, United States
Lloyd Gayle
New York, New York, United States
Raymond Isakov
Cleveland, Ohio, United States
Craig Colville
Toledo, Ohio, United States
Frank Barone
Toledo, Ohio, United States
Mary Gingrass
Nashville, Tennessee, United States
Patrick Maxwell
Nashville, Tennessee, United States
Jeffrey Friedman
Houston, Texas, United States
Thomas Blanchard
Newport News, Virginia, United States
Countries
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Other Identifiers
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410XL-001
Identifier Type: -
Identifier Source: org_study_id
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