NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval S⦠(NCT01853605) | Clinical Trial Compass
TerminatedNot Applicable
NATRELLEĀ® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Stopped: The study was discontinued following product approval.
United States3,811 participantsStarted 2003-04
Plain-language summary
Post-approval study of the safety and effectiveness of NATRELLEĀ® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
Who can participate
Age range18 Years
SexFEMALE
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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 NATRELLEĀ® 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 ā¦
What they're measuring
1
Subject Satisfaction With Breast Implants on a 5-Point Scale
Timeframe: 5 years
2
Investigator Satisfaction With Breast Implants on a 5-Point Scale