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Compassionate Use of the Becker Expander/Breast Implant

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ClinicalTrials.gov Identifier: NCT01000012
Recruitment Status : No longer available
First Posted : October 22, 2009
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC

Study Description
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Brief Summary:

To provide access of the Becker Expander/Breast implant to women who do not meet inclusion/exclusion criteria of the Becker Continued Access Study

Patients' physician will contact Mentor to request use of the device and each request will be reviewed by Mentor, an IRB, and the FDA on a case-by-case basis


Condition or disease Intervention/treatment
Breast Reconstruction Device: Becker 50 Expander/Breast implant Device: Becker 25 Expander/Breast implant

Study Design
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Study Type : Expanded Access
Official Title: Compassionate Use of the Becker Expander/Breast Implant

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Interventions
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Intervention Details:
    Device: Becker 50 Expander/Breast implant

    The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.

    The Becker 50 Expander/Breast Implant has a 50% gel volume and a 50% saline volume, so a 400cc implant would nominally have 200cc of saline and 200cc of silicone. The Becker 50 Expander/Breast Implant is available in sizes from 300 to 700cc.

    Device: Becker 25 Expander/Breast implant

    The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.

    The Becker 25 Expander/Breast Implant has a silicone gel volume of approximately 25% and saline volume of approximately 75%. The Becker Expander/Breast Implant is available in sizes 150 - 800cc.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Women who require a Becker Expander/Breast implant who do not meet inclusion/exclusion criteria of the Becker Continued Access Study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000012


Locations
United States, California
Mentor Worldwide LLC
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
Mentor Worldwide, LLC
More Information
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Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT01000012     History of Changes
Other Study ID Numbers: A101-0501-08cu
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013