Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
1 other identifier
interventional
941
1 country
1
Brief Summary
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
February 4, 2014
CompletedOctober 13, 2014
December 1, 2013
11.8 years
June 2, 2008
December 17, 2013
October 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Local Complications
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
10 years
Secondary Outcomes (1)
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.
10 years
Study Arms (4)
1
EXPERIMENTALAugmentation
2
EXPERIMENTALReconstruction
3
EXPERIMENTALRevision-augmentation
4
EXPERIMENTALRevision-reconstruction
Interventions
Eligibility Criteria
You may qualify if:
- Female, age 18 years or older
- Patients seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: Patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, aplasia
- Patients seeking breast reconstruction
- Patients seeking breast revision-augmentation
- Patients seeking breast revision-reconstruction
- Adequate tissue available to cover implants
- Patients must be willing to undergo MRI at their 1, 3, 5, 7, and 10-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).
You may not qualify if:
- Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
- Existing carcinoma of the breast, without mastectomy
- Abscess or infection in the body at the time of enrollment
- Pregnant or nursing
- Have any disease, including uncontrolled diabetes (e.g., Hb AIc \> 8%), that is clinically known to impact wound healing ability
- Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration
- Have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
- 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)
- Are not willing to undergo further surgery for revision, if medically required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allergan Medicallead
Study Sites (1)
Unknown Facility
Indianapolis, Indiana, United States
Related Publications (5)
Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell GP; Style 410 U.S. Core Clinical Study Group. Style 410 highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):40S-48S. doi: 10.1097/01.prs.0000286666.29101.11.
PMID: 18090813RESULTGladfelter J, Murphy D. Breast augmentation motivations and satisfaction: a prospective study of more than 3,000 silicone implantations. Plast Surg Nurs. 2008 Oct-Dec;28(4):170-4; quiz 175-6. doi: 10.1097/PSN.0b013e31818ea7e0.
PMID: 19092580RESULTMaxwell GP, Van Natta BW, Murphy DK, Slicton A, Bengtson BP. Natrelle style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J. 2012 Aug;32(6):709-17. doi: 10.1177/1090820X12452423. Epub 2012 Jun 29.
PMID: 22751081RESULTLargent JA, Reisman NR, Kaplan HM, Oefelein MG, Jewell ML. Clinical trial outcomes of high- and extra high-profile breast implants. Aesthet Surg J. 2013 May;33(4):529-39. doi: 10.1177/1090820X13484035. Epub 2013 Apr 4.
PMID: 23559355RESULTNamnoum JD, Largent J, Kaplan HM, Oefelein MG, Brown MH. Primary breast augmentation clinical trial outcomes stratified by surgical incision, anatomical placement and implant device type. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):1165-72. doi: 10.1016/j.bjps.2013.04.046. Epub 2013 May 9.
PMID: 23664574RESULT
Results Point of Contact
- Title
- Medical Monitor
- Organization
- Allergan, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2008
First Posted
June 4, 2008
Study Start
February 1, 2001
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 13, 2014
Results First Posted
February 4, 2014
Record last verified: 2013-12