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Compassionate Use of the Becker Expander/Breast Implant

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT01000012
First received: October 21, 2009
Last updated: October 28, 2013
Last verified: October 2013
History of Changes
  Purpose

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 Intervention
Breast Reconstruction
 Device: Becker 50 Expander/Breast implant
Device: Becker 25 Expander/Breast implant

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mentor Worldwide, LLC:
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000012

Locations
United States, California
Mentor Worldwide LLC
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
Mentor Worldwide, LLC
  More Information

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT01000012     History of Changes
Other Study ID Numbers: A101-0501-08cu 
Study First Received: October 21, 2009
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 28, 2016