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Compassionate Use of the Becker Expander/Breast Implant

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

October 21, 2009
October 22, 2009
October 29, 2013
 
Compassionate Use of the Becker Expander/Breast Implant

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

Not Provided
Expanded Access
  • 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.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01000012
Mentor Worldwide, LLC
Mentor Worldwide, LLC
Not Provided
Not Provided
Mentor Worldwide, LLC
October 2013