Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

Not Applicable

Terminated

• Conditions: Breast Augmentation; Breast Reconstruction; Breast Implant Revision
• Interventions: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection

• Registration Number: NCT01785069
• Lead Sponsor: Allergan

Brief Summary

This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12-10
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-06
• Primary Completion: 2015-11-30
• Study Completion: 2015-11-30
• Results First Submitted: 2020-05-13
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Results First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 355

Inclusion Criteria

For entry in this study, participants must have been enrolled in the 410 Continued Access (CA) Clinical Study or 410 Continued Access Reconstruction/Revision Expansion (CARE) Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Styles or L-Styles breast implants

• Female, age 18 or older

• 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)

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Exclusion Criteria

For entry in this study, participants must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study, meeting the exclusion criteria listed below, did not receive any NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled FM, FF, MM, or MF Style Breast Implants, and have not undergone implant removal with or without replacement surgery

• Does not have advance fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Revision-Reconstruction	Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection	Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
Augmentation	Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection	Women who had breast augmentation with NATRELLE® 410 implants.
Reconstruction	Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection	Women who had breast reconstruction with NATRELLE® 410 implants.
Revision-Augmentation	Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection	Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants According to Investigator Satisfaction With Implants	3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)	The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied,3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported.
Percentage of Participants According to Participant Satisfaction With Implants	3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)	The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Local Complications	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)	Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast Pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Implant malposition, Implant palpability/visibility. Implant rupture, Infection, Ptosis, Redness, Swelling, Wrinkling/rippling and Other complications (calcifications on mammogram, thing of mastectomy flap, deformity and nipple stretching).
Percentage of Participants With Reoperations	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)	Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.
Percentage of Participants With Implant Removal With or Without Replacement	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)	Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement

Trial Locations

Locations (29)

Laurence Berkowitz; 🇺🇸 Campbell, California, United States

Roy Hong; 🇺🇸 Palo Alto, California, United States

James Namnoum; 🇺🇸 Atlanta, Georgia, United States

Janet Turkle; 🇺🇸 Carmel, Indiana, United States

Walter Erhardt; 🇺🇸 Albany, Georgia, United States

Julene Samuels; 🇺🇸 Louisville, Kentucky, United States

Herluf Jr. Lund; 🇺🇸 Chesterfield, Missouri, United States

Charles Nathan; 🇺🇸 Chesterfield, Missouri, United States

Patricia McGuire; 🇺🇸 Creve Coeur, Missouri, United States

Lloyd Gayle; 🇺🇸 New York, New York, United States

Frank Barone; 🇺🇸 Toledo, Ohio, United States

Patrick Maxwell; 🇺🇸 Nashville, Tennessee, United States

Eric Bachelor; 🇺🇸 Pleasanton, California, United States

Tracy Pfeifer; 🇺🇸 Great Neck, New York, United States

Raymond Isakov; 🇺🇸 Cleveland, Ohio, United States

Craig Colville; 🇺🇸 Toledo, Ohio, United States

Gregory Liebscher; 🇺🇸 Colorado Springs, Colorado, United States

Perry Johnson; 🇺🇸 Omaha, Nebraska, United States

Steven Morris; 🇺🇸 Midland, Michigan, United States

Peter Hetzler; 🇺🇸 Little Silver, New Jersey, United States

Mary Gingrass; 🇺🇸 Nashville, Tennessee, United States

Scott Spear; 🇺🇸 Washington, District of Columbia, United States

Timothy Mickel; 🇺🇸 Monroe, Louisiana, United States

Peter Hyans; 🇺🇸 Berkeley Heights, New Jersey, United States

Calvin Peters; 🇺🇸 Orlando, Florida, United States

John Renucci; 🇺🇸 Grand Rapids, Michigan, United States

Caroline Glicksman; 🇺🇸 Sea Girt, New Jersey, United States

Jeffrey Friedman; 🇺🇸 Houston, Texas, United States

Thomas Blanchard; 🇺🇸 Newport News, Virginia, United States