Memorygel™ Postapproval Study For Mentor Silicone Gel-Filled Breast Implants - Full Text View

Sponsor:	Kaiser Permanente
Collaborator:	Mentor Corporation
Information provided by:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00495534

Purpose

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 reliability of the approved device for its intended use. These studies are conducted under an FDA-approved protocol with the intended purpose of gathering specific additional information about the marketed device.

Condition	Intervention
Postoperative Complications Mammaplasty	Device: Mentor MemoryGel Silicone Gel-filled breast implants

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Memorygel™ Postapproval Study Of Mentor Memorygel Breast Implants In Women Undergoing Breast Augmentation Or Reconstruction

Resource links provided by NLM:

MedlinePlus related topics: Breast Reconstruction

Drug Information available for: Silicone

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	42900
Study Start Date:	March 2007
Estimated Study Completion Date:	October 2018

Intervention Details:

implantation of Mentor MemoryGel Silicone Gel-filled breast implant

Detailed Description:

As a condition of gaining access to the approved silicone gel filled breast implants, the first 41,900 women will participate in the 10 year study. In addition, there will be a concurrent control group of 1000 women with saline filled breast implants to serve as concurrent controls for assessing rheumatologic and neurologic signs and symptoms. The study methods include a baseline questionnaire, a device tracking form, a visit at one year post-op, a visit at four to six years post-op, a visit nine to ten years post-op, and the questionnaire at the time of any participants discontinuation (when possible).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

members and nonmembers of the Kaiser Foundation Health Plan who present for implantation of the Mentor Silicone Gel-filled breast implant at a Kaiser Permanente medical facility in Northern California

Criteria

MemoryGel Breast Implant Participants

Inclusion Criteria:

Must be a woman who

Is a candidate for breast augmentation with Mentor MemoryGel breast implants and is at least 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with Mentor MemoryGel breast implants.
Signs an Acknowledgement of Informed Decision from the patient brochure.
Signs an Informed Consent Form and an Authorization to Disclose Health Information and Release Medical Records.
Completes the baseline questionnaire (as evidenced by the participant's signature on the last page of the questionnaire).
Agrees to authorize return of the device(s) to Mentor if the device is explanted.
Agrees via Informed Consent to comply with the study follow-up, including full participation in all follow-up questionnaires and responding to questionnaires in their entirety.
Is a U.S. resident.

Exclusion Criteria:

Has active infection anywhere in her body
Has existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
Is currently pregnant or nursing

Saline Breast Implant Control Participants

Inclusion Criteria:

Is triggered as part of the selection process for concurrent controls
Is a candidate for breast augmentation and is at least 18 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with saline breast implants.
Signs an Informed Consent Form and an Authorization to Disclose Health Information and Release Medical Records.
Completes the baseline questionnaire (as evidenced by the participant's signature on the last page of the questionnaire).
Agrees to authorize return of the device(s) to Mentor if they are Mentor devices
Agrees via Informed Consent to comply with the study follow-up, including full participation in all follow-up questionnaires and responding to questionnaires in their entirety.
Is a U.S. resident.

Exclusion criteria:

Has current or past, unilateral or bilateral, silicone breast implants
Has active infection anywhere in her body
Has existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
Is currently pregnant or nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495534

Locations

United States, California
Kaiser Permanente
Sacramento, California, United States, 95825-2115
Kaiser Permanente
Santa Rosa, California, United States, 95403
Kaiser Permanente
Oakland, California, United States, 94611-5642
Kaiser Permanente
Napa, California, United States, 94558
Kaiser Permanente
Richmond, California, United States, 94801-3143

Sponsors and Collaborators

Kaiser Permanente

Mentor Corporation

Investigators

Study Chair:

William Strull, M.D.

Kaiser Permanente Northern California Biomedical Institutional Review Board

More Information

Additional Information:

Mentor MemoryGel Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mentor Corporation ( Ms. Nou Moua )
Study ID Numbers:	CN-07HManc-01-B
Study First Received:	July 2, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00495534 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Kaiser Permanente:

Silicone
Gel
Implant
breast
cicatrix

Additional relevant MeSH terms:

Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on November 25, 2009