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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Laurence Berkowitz
    • Palo Alto, California, United States, 94301
      • Roy Hong
    • Pleasanton, California, United States, 94566
      • Eric Bachelor
  • Colorado
    • Colorado Springs, Colorado, United States, 80919
      • Gregory Liebscher
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Scott Spear
  • Florida
    • Orlando, Florida, United States, 32801
      • Calvin Peters
  • Georgia
    • Albany, Georgia, United States, 31701
      • Walter Erhardt
    • Atlanta, Georgia, United States, 30342
      • James Namnoum
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Janet Turkle
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Julene Samuels
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Timothy Mickel
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • John Renucci
    • Midland, Michigan, United States, 48640
      • Steven Morris
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Charles Nathan
    • Chesterfield, Missouri, United States, 63005
      • Herluf Jr. Lund
    • Creve Coeur, Missouri, United States, 63141
      • Patricia McGuire
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Perry Johnson
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Peter Hyans
    • Little Silver, New Jersey, United States, 07739
      • Peter Hetzler
    • Sea Girt, New Jersey, United States, 08750
      • Caroline Glicksman
  • New York
    • Great Neck, New York, United States, 10028
      • Tracy Pfeifer
    • New York, New York, United States, 10021
      • Lloyd Gayle
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Raymond Isakov
    • Toledo, Ohio, United States, 43615
      • Craig Colville
    • Toledo, Ohio, United States, 43623
      • Frank Barone
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Patrick Maxwell
    • Nashville, Tennessee, United States, 37203
      • Mary Gingrass
  • Texas
    • Houston, Texas, United States, 77030
      • Jeffrey Friedman
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Thomas Blanchard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmentation; Women who had breast augmentation with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants
Experimental: Reconstruction; Women who had breast reconstruction with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants
Experimental: Revision-Augmentation; Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants
Experimental: Revision-Reconstruction; Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants According to Investigator Satisfaction With Implants	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.	3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Percentage of Participants According to Participant Satisfaction With Implants	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.	3 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Local Complications	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).	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Percentage of Participants With Reoperations	Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported.	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)
Percentage of Participants With Implant Removal With or Without Replacement	Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement	5 years (followup after implantation that occurred between 07 July 2009 and 01 January 2012)

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Chair: Andrew Schumacher, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2012
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: January 14, 2013
• First Submitted That Met QC Criteria: February 4, 2013
• First Posted (Estimate): February 6, 2013

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 410XL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes