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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1951
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Anthony Griffin
    • Campbell, California, United States, 95008
      • Laurence Berkowitz
    • Long Beach, California, United States, 90806
      • Mary Powers
    • Palo Alto, California, United States, 94301
      • Roy Hong
    • Pleasanton, California, United States, 94566
      • Eric Bachelor
    • San Diego, California, United States, 92128
      • Douglas Reavie
    • Santa Monica, California, United States, 90404
      • Steven Teitelbaum
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Tad Heinz
    • Denver, Colorado, United States, 80218
      • Gary Snider
    • Englewood, Colorado, United States, 80113
      • Terrence Murphy
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • Orlando De Lucia
  • Florida
    • Tampa, Florida, United States, 33607
      • Lewis Berger
    • Tampa, Florida, United States, 33647
      • Gerard Mosiello
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • James Namnoum
  • Illinois
    • Des Plaines, Illinois, United States, 60016
      • Peter Johnson
    • Elk Grove Village, Illinois, United States, 60007
      • Stephen Madry
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Janet Turkle
    • Indianapolis, Indiana, United States, 46290
      • Bruce Van Natta
    • Indianapolis, Indiana, United States, 46290
      • Christine Kelley-Patteson
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Brad Storm
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Julene Samuels
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Timothy Mickel
    • Shreveport, Louisiana, United States, 71105
      • Paul Davis
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Bradley Bengtson
    • 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 Lund Jr.
    • Creve Coeur, Missouri, United States, 63141
      • Patricia McGuire
    • Hannibal, Missouri, United States, 63401
      • Schuyler Meltis
  • Nebraska
    • Omaha, Nebraska, United States, 68102
      • Perry Johnson
    • Omaha, Nebraska, United States, 68118
      • Perry Johnson
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Peter Hyans
    • Florham Park, New Jersey, United States, 07932
      • Isaac Starker
    • Little Silver, New Jersey, United States, 07739
      • Peter Hetzler
    • Princeton, New Jersey, United States, 08540
      • Marc Alan Drimmer
    • Sea Girt, New Jersey, United States, 08750
      • Caroline Glicksman
  • New York
    • New York, New York, United States, 10021
      • Lloyd Gayle
    • New York, New York, United States, 10028
      • John Sherman
    • New York, New York, United States, 10028
      • Tracy Pfeifer
    • Port Jefferson Station, New York, United States, 11776
      • Robert Jacobs
    • Staten Island, New York, United States, 10306
      • John Decorato
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Raymond Isakov
    • Toledo, Ohio, United States, 43615
      • Craig Colville
    • Toledo, Ohio, United States, 43623
      • Frank Barone
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Derek Shadid
    • Oklahoma City, Oklahoma, United States, 73134
      • Robert Hein
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Mark Jewell
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • John Lettieri
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Kristina D. O'Shaughnessy
    • Nashville, Tennessee, United States, 37212
      • Patrick Maxwell
  • Texas
    • Dallas, Texas, United States, 75246
      • William Carpenter
    • Houston, Texas, United States, 77030
      • Jeffrey Friedman
    • Plano, Texas, United States, 75093
      • Natan Yaker
    • University Park, Texas, United States, 75205
      • William Adams
  • Virginia
    • McLean, Virginia, United States, 22101
      • Gloria Duda
  • Washington
    • Bellevue, Washington, United States, 98005
      • Gavin Dry
    • Vancouver, Washington, United States, 98664
      • Allen Gabriel

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 either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts; or be planning to be implanted with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and meet the inclusion criteria listed below:

• 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:

For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and did not meet the exclusion criteria listed below or plan to undergo implantation with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and does not meet the exclusion criteria listed below:

• 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

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 height/projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)
Experimental: Reconstruction; Women who had breast reconstruction with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)
Experimental: Revision-Augmentation; Women who had revision of previous breast augmentation with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)
Experimental: Revision-Reconstruction; Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.	Device: Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection; Surgical implant; Other Names: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles FX, MX, LX, FL, ML, LL, LM, and LF)

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.	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
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.	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)

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, Hematoma, Hypertrophic scarring/other abnormal scarring, Implant extrusion, Implant malposition, Implant palpability/visibility, Implant rupture, Infection, Redness, Skin rash, Swelling, Tissue/skin necrosis, Upper pole fullness, Wrinkling/rippling and Other complications .	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
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 06 May 2008 and 08 January 2015)
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 is reported.	5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2013
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 410CAXL-001

Drug and device information, study documents

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