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

Allergan

Status: Terminated

Conditions: Breast Reconstruction; Breast Augmentation; Breast Implant Revision

Treatments: Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01785069

410XL-001

Details and patient eligibility

About

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.

Enrollment: 355 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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355 participants in 4 patient groups

Augmentation

Experimental group

Description:

Women who had breast augmentation with NATRELLE® 410 implants.

Treatment:

Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection

Reconstruction

Experimental group

Description:

Women who had breast reconstruction with NATRELLE® 410 implants.

Treatment:

Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection

Revision-Augmentation

Experimental group

Description:

Women who had revision of a previous breast augmentation with NATRELLE® 410 implants.

Treatment:

Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection

Revision-Reconstruction

Experimental group

Description:

Women who had revision of a previous breast reconstruction with NATRELLE® 410 implants.

Treatment:

Device: Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection