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

NCT01853605 | Terminated Results

• 1 other identifier: 410CA-002
• Study Type: interventional
• Target: 3,811
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Augmentation; Breast Reconstruction; Breast Implant Revision

Outcome Measures

Primary Outcomes (3)

• Subject Satisfaction With Breast Implants on a 5-Point Scale

  Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.

  5 years

• Investigator Satisfaction With Breast Implants on a 5-Point Scale

  Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.

  5 years

• Local Complications

  Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.

  5 years

Study Arms (4)

Augmentation

EXPERIMENTAL

Women undergoing breast augmentation.

Device: Anatomically shaped silicone gel-filled breast implants

Reconstruction

EXPERIMENTAL

Women undergoing breast reconstruction.

Device: Anatomically shaped silicone gel-filled breast implants

Revision-Augmentation

EXPERIMENTAL

Women undergoing revision of previous breast augmentation.

Device: Anatomically shaped silicone gel-filled breast implants

Revision-Reconstruction

EXPERIMENTAL

Women undergoing revision of previous breast reconstruction.

Device: Anatomically shaped silicone gel-filled breast implants

Interventions

Anatomically shaped silicone gel-filled breast implants DEVICE

Surgical implant

Also known as: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)

Augmentation; Reconstruction; Revision-Augmentation; Revision-Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Eugene, Oregon, United States

Location

Results Point of Contact

• Title: Allergan Inc.,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

Study Officials

• Medical Director

  Allergan Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 15, 2013
• Study Start: April 1, 2003
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 11, 2015
• Results First Posted: August 11, 2015

Record last verified: 2015-07

Locations

US (1)