Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis - Full Text View

Sponsors and Collaborators:	Kaiser Permanente Mentor Corporation
Information provided by:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00495937

Purpose

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, which will encompass clinical reviews of reconstructive cases in all patients who meet clinical and regulatory criteria for breast reconstruction with gel-filled mammary prostheses. This “adjunct” study will be accomplished under a limited clinical protocol in which specific parameters will be required but with controls somewhat less stringent than those normally required in Investigational Device Exemption (IDE) trials.

Gel-filled implants are available only to physicians participating in the study. By participating in the study, we can offer our patients an alternative to saline-filled mammary prostheses. The option would be made available to reconstructive patients post-mastectomy as well as to cosmetic patients in whom saline-filled implants have proven unsatisfactory according to the parameters outlined in the study.

Condition	Intervention	Phase
Cicatrix Postoperative Complications	Device: Mentor Silicone gel-filled breast implants	Phase III

MedlinePlus related topics: Breast Reconstruction Scars

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

Mentor is undertaking a prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses. [ Time Frame: 5 years ]

Secondary Outcome Measures:

The study includes the risks inherent in breast implants including but not limited to infection acute and late; bleeding acute and late with hematoma and/or seroma; scarring with capsular contracture; implant failure, deflation, rupture and leakage. [ Time Frame: 5 years ]

Enrollment:	45
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2010

Detailed Description:

The study includes the risks inherent in breast implants including but not limited to infection acute and late; bleeding acute and late with hematoma and/or seroma; scarring with capsular contracture; implant failure, deflation, rupture and leakage. When silicone gel-filled implants rupture, some women may notice decreased breast size, nodules, uneven appearance, pain, tenderness, tingling, swelling, numbness, burning or changes in sensation. Other women may not have any symptoms. Silicone gel which escapes the fibrotic capsule may migrate away from the breast causing granulomas.
Patients are asked to enroll in an implant registry. The study calls for reexamination at one, three, and five years. Magnetic Resonance Imaging (MRI) with equipment specifically designed for imaging the breast may be used for evaluating patients with suspected rupture or leakage of their silicone gel-filled implant.
The benefits of the study are the objectives of the study, viz., to gather safety data regarding short-term, post-implant events and complications to support Pre-market Approval (PMA) submissions to the FDA while making otherwise unavailable silicone gel-filled implants available to women.
The surgery as well as participation in the study is purely elective on the part of the participants. Simply stated, the study is an approved means to making silicone gel-filled implants available to women undergoing breast reconstruction and secondary implant surgery.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Must be female
Must be willing to follow the study requirements
- Sign the informed consent
- Agree to complete all required follow-up visits
- Follow the requirements of the Registry Program if they wish to participate
- Agree to explant analysis
- Be a medically acceptable candidate
In the surgeon's opinion, saline implants are unsuitable for the patient
Must have one or more of the following breast conditions:
- Post mastectomy
- Require reconstruction due to cancer treatments other than mastectomy
- Require revision due to complications or other undesirable results of a previous surgery for the above reasons
- Post trauma
- Congenital deformities
- Severe ptosis defined as requiring a reconstructive procedure
- Patients who require implant replacement for severe deformity
- Replacement for patients for whom saline implants are unsuitable
- Size changes for medical reasons
- Augmentation in the unaffected breast as a result of surgery in the affected breast
- Special circumstances on a case-by-case basis

Exclusion Criteria:

Abscess or infection anywhere in body
Pregnant or nursing
Diagnosed with lupus or scleroderma
Uncontrolled diabetes or other disease which impacts healing
Incompatible tissue characteristics (i.e., radiation damage)
Unwarranted surgical risk
Psychological reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495937

Locations

United States, California
Kaiser Permanente
Santa Rosa, California, United States, 95403
Kaiser Permanente
Oakland, California, United States, 94611

Sponsors and Collaborators

Kaiser Permanente

Mentor Corporation

Investigators

Study Chair:

William Strull, MD

Kaiser Permanente

More Information

Study ID Numbers:	CN-05HManc-01-B
Study First Received:	July 2, 2007
Last Updated:	July 2, 2007
ClinicalTrials.gov Identifier:	NCT00495937
Health Authority:	United States: Institutional Review Board

Keywords provided by Kaiser Permanente:

Mentor
Silicone
gel-filled
breast implant

Study placed in the following topic categories:

Skin Diseases
Postoperative Complications
Cicatrix

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009