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

NCT ID: NCT01853605

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3811 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2014-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Augmentation

Women undergoing breast augmentation.

Group Type: EXPERIMENTAL

Anatomically shaped silicone gel-filled breast implants

Intervention Type: DEVICE

Surgical implant

Reconstruction

Women undergoing breast reconstruction.

Group Type: EXPERIMENTAL

Anatomically shaped silicone gel-filled breast implants

Intervention Type: DEVICE

Surgical implant

Revision-Augmentation

Women undergoing revision of previous breast augmentation.

Group Type: EXPERIMENTAL

Anatomically shaped silicone gel-filled breast implants

Intervention Type: DEVICE

Surgical implant

Revision-Reconstruction

Women undergoing revision of previous breast reconstruction.

Group Type: EXPERIMENTAL

Anatomically shaped silicone gel-filled breast implants

Intervention Type: DEVICE

Surgical implant

Interventions

Anatomically shaped silicone gel-filled breast implants

Surgical implant

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan Medical

Locations

Eugene, Oregon, United States

Countries

United States

Other Identifiers

410CA-002

Identifier Type: -

Identifier Source: org_study_id