Clinical trial NCT01853605: NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Augmentation
Breast Reconstruction
Breast Implant Revision
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 3811
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Subject Satisfaction With Breast Implants on a 5-Point Scale
timeFrame: 5 years
measure: Investigator Satisfaction With Breast Implants on a 5-Point Scale
timeFrame: 5 years
measure: Local Complications
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
state: Oregon
Study officials:
affiliation: Allergan Medical
name: Medical Director
role: STUDY_DIRECTOR
References: