Inamed 410 Style Silicone Breast Implant Study - Full Text View

Sponsor:	Georgetown University
Collaborator:	Inamed
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00557674

Purpose

This study is designed to provide access to a shaped, silicone-filled implant to reconstruction and revision patients and to provide additional information to the Style 410 IDE regarding the safety and effectiveness of Inamed Style 410 Silicone-Filled Breast Implants in women undergoing breast implant reconstruction or revision surgery.

Condition	Intervention	Phase
Benefits and Risks of Receiving the Style 410 Silicone Implant	Device: Style 410 silicone implant	Phase III

Study Type:	Interventional
Study Design:	Screening, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Inamed Corporation Style 410 Silicone-Filled Breast Implant Clinical Study: Continued Access

Resource links provided by NLM:

MedlinePlus related topics: Breast Reconstruction Surgery

Drug Information available for: Silicone

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:

The primary study outcome is that the Style 410 silicone implant will be determined to be safe device and benefit women who chose to have breast reconstruction, augmentation, or revised previous implant surgery. [ Time Frame: within 10 years of implantation ]

Secondary Outcome Measures:

Women will benefit both physically and psychologically from receiving Style 410 silicone implants. [ Time Frame: within 10 years of implantation ]

Enrollment:	45
Study Start Date:	June 2001
Estimated Study Completion Date:	June 2017

Arms	Assigned Interventions
1 Breast reconstruction	Device: Style 410 silicone implant Silicone implant
2 Revision breast implant surgery	Device: Style 410 silicone implant Silicone implant
3 Augmentation	Device: Style 410 silicone implant Silicone implant

Detailed Description:

The Food and Drug Administration (FDA) has issued a guidance document requiring that clinical studies be conducted to establish the safety and efficacy of silicone-filled breast implants ("Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses", January 13, 2004). The Inamed Style 410 Silicone-Filled Breast Implant is an experimental device that is available to patients who participate in this clinical study.

After implantation, the study schedule requires follow-up visits at 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years after your surgery. Case Report Forms (CRFs)on Quality of Life and Activity and Lifestyles will be completed by each patient at annual visits. Photographs of the breast/chest area will be taken prior to surgery and one year after surgery. Anyone scheduled for explantation of the study implant(s) for any reason will be asked to obtain a magnetic resonance imaging procedure (MRI) immediately prior to explant surgery, if medically advisable.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Be a female 18 years of age or older,
Have a condition appropriate for breast augmentation, reconstruction or revision
Have adequate tissue available to cover the implant(s),
Complete a screening by your surgeon, and
Be willing to sign this Informed Consent document which gives you information about your breast implants and confirms your commitment to follow study requirements and acceptance of the potential risks involved.
Be willing to have a magnetic resonance imaging procedure (MRI) performed immediately prior to explantation, if medically advisable.

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557674

Sponsors and Collaborators

Georgetown University

Inamed

Investigators

Principal Investigator:

Scott L Spear, MD

Georgetown University Hospital

More Information

No publications provided

Study ID Numbers:	2006-313, 4359-611
Study First Received:	November 13, 2007
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00557674 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Georgetown University:

Style 410 Silicone Implant
Silicone Implants
Breast Reconstruction

Breast Augmentation
Inamed
Allergan Medical

ClinicalTrials.gov processed this record on February 08, 2010