NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT01853605
First received: May 13, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision


Condition Intervention
Breast Augmentation
Breast Reconstruction
Breast Implant Revision
Device: Anatomically shaped silicone gel-filled breast implants

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Subject and Investigator satisfaction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The percentage of subjects and Investigators who are satisfied or definitely satisfied on a 5-point scale (definitely satisfied to definitely dissatisfied)


Estimated Enrollment: 1000
Study Start Date: May 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Augmentation
Women undergoing breast augmentation
Device: Anatomically shaped silicone gel-filled breast implants
Surgical implant
Other Name: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Reconstruction
Women undergoing breast reconstruction
Device: Anatomically shaped silicone gel-filled breast implants
Surgical implant
Other Name: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Revision-Augmentation
Women undergoing revision of previous breast augmentation
Device: Anatomically shaped silicone gel-filled breast implants
Surgical implant
Other Name: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Experimental: Revision-Reconstruction
Women undergoing revision of previous breast reconstruction
Device: Anatomically shaped silicone gel-filled breast implants
Surgical implant
Other Name: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Styles 410 FM, FF, MM, or MF in 1 (for unilateral breast reconstruction or revision) or both breasts.

  • Female, age 18 or older
  • Present with one or more of the following conditions:

    • 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
    • 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
  • Willing to undergo MRI at the specified follow-up visit 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, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and met the exclusion criteria listed below but not received any NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled 410 X- or L-Style Breast Implants

  • Does not have advanced 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., 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853605

Locations
United States, Oregon
Eugene, Oregon, United States
Sponsors and Collaborators
Allergan Medical
Investigators
Study Director: Medical Director Allergan Medical
  More Information

No publications provided

Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT01853605     History of Changes
Other Study ID Numbers: 410CA-002
Study First Received: May 13, 2013
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014