Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study

Breast Reconstruction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690339
• Other study ID #: 00201
• Status: Completed
• Phase: N/A
• First received: June 2, 2008
• Last updated: October 6, 2014
• Start date: February 2001
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.

Other known NCT identifiers

• NCT00557674

Recruitment information / eligibility

• Status: Completed
• Enrollment: 941
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Reconstruction
• Revision of Augmentation or Reconstruction

Intervention

Device:
• Style 410 Silicone-Filled Breast Implants
Breast Implant Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan Medical

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Gladfelter 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. — View Citation

Largent 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. Review. — View Citation

Maxwell 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. — View Citation

Namnoum 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Complications	By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts	10 years	Yes
Secondary	Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.	Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied	10 years	No