Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Summary
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Conditions
Breast Augmentation
Intervention
Style 410 Silicone-Filled Breast Implants
Location
Indianapolis
Indiana
United States
Status
Active, not recruiting
Source
Allergan Medical
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00690339
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Breast Implants
Implants used to reconstruct and/or cosmetically enhance the female breast. They have an outer shell or envelope of silicone elastomer and are filled with either saline or silicone gel. The outer shell may be either smooth or textured.
Breast Cyst
A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.
Silicone Gels
Synthetic organosiloxane gels that are formed from synthetic polymers of silicone oxide with organic sidechains (polydimethylsiloxane) by lengthening the polymer chains. Unlike silicone elastomers, they are not treated with amorphous silica. They are used as fillers in breast implants.
Breast Implantation
Surgical insertion of an inert sac filled with silicone or other material to augment the female form cosmetically.
Fibrocystic Breast Disease
A common and benign breast disease characterized by varying degree of fibrocystic changes in the breast tissue. There are three major patterns of morphological changes, including FIBROSIS, formation of CYSTS, and proliferation of glandular tissue (adenosis). The fibrocystic breast has a dense irregular, lumpy, bumpy consistency.
Clinical Trials
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants
The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-fill...
Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
Mentor is undertaking a prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses. This study is an "adjunct" study,...
Memorygel™ Postapproval Study For Mentor Silicone Gel-Filled Breast Implants
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) occasionally requires post-approval studies to help monitor the safety, effectiveness, and r...
Mentor MemoryGel Post-Approval Study
The U.S. Food and Drug Administration (FDA) recently approved Mentor's MemoryGel™ silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast aug...
PubMed Articles
Silicone lymphadenopathy: an unexpected cause of neck lumps.
Objective:To report a rare case of silicone lymphadenopathy solely affecting the left supraclavicular lymph nodes.Case report:Our patient presented with a painless swelling in the left supraclavicular...
BACKGROUND: Currently, postoperative outcome analysis in breast augmentation is essentially subjective, and objective evaluation of treatment efficacy is lacking. This study evaluates the influence of...
Aesthetic breast augmentation.
Breast augmentation has become one of the most popular procedures in aesthetic plastic surgery. In addition to the well-established procedure for breast enlargement with silicone implants, two further...
BACKGROUND:: Capsular contracture is one of the most common and trying complications associated with the placement of breast prostheses. We hypothesized that silicone implants have a higher rate of ca...
