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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785069
Recruitment Status : Terminated (There was no indication that long-term follow-up would differ between any of the studies that have evaluated devices within the 410 Style Matrix.)
First Posted : February 6, 2013
Results First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE January 14, 2013
First Posted Date  ICMJE February 6, 2013
Results First Submitted Date  ICMJE May 13, 2020
Results First Posted Date  ICMJE June 25, 2020
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE December 10, 2012
Actual Primary Completion Date November 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
  • Percentage of Participants According to Investigator Satisfaction With Implants [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
  • Percentage of Participants With Local Complications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Augmentation
  • Breast Reconstruction
  • Breast Implant Revision
Intervention  ICMJE Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Surgical implant
Other Name: NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled Breast Implants
Study Arms  ICMJE
  • Experimental: Augmentation
    Women who had breast augmentation with NATRELLE® 410 implants.
    Intervention: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
  • Experimental: Reconstruction
    Women who had breast reconstruction with NATRELLE® 410 implants.
    Intervention: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
  • Experimental: Revision-Augmentation
    Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.
    Intervention: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
  • Experimental: Revision-Reconstruction
    Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.
    Intervention: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 23, 2020)
355
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 30, 2015
Actual Primary Completion Date November 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01785069
Other Study ID Numbers  ICMJE 410XL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Andrew Schumacher Allergan
PRS Account Allergan
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP