NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study

Allergan

Status: Terminated

Conditions: Breast Reconstruction; Breast Augmentation; Breast Implant Revision

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01870869

410CAXL-001

Details and patient eligibility

About

This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants for breast augmentation, reconstruction, or revision.

Enrollment: 1,951 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts; or be planning to be implanted with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and meet the inclusion criteria listed below:

• Female, age 18 or older (age 22 or older for breast augmentation participants who are implanted under Protocol 410CAXL-001)

• Present with 1 or more of the following conditions:

  • Primary breast augmentation (i.e., no previous breast implant surgery) indicated for participant 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

Exclusion criteria

For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and did not meet the exclusion criteria listed below or plan to undergo implantation with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and does not meet the exclusion criteria listed below:

• Has an advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
• Has an existing carcinoma of the breast, without mastectomy
• Has an abscess or infection in the body at the time of enrollment
• Is pregnant or nursing
• Has any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) > 8%), that is clinically known to impact wound healing ability
• Shows tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration
• Has or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
• Shows 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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1,951 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 height/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 height/projection or extra-full projection

Revision-Augmentation

Experimental group

Description:

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

Treatment:

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

Revision-Reconstruction

Experimental group

Description:

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

Treatment:

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