|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Mentor Worldwide, LLC |
|---|---|
| Information provided by (Responsible Party): | Mentor Worldwide, LLC |
| ClinicalTrials.gov Identifier: | NCT01000012 |
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 |
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.
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 |
| Genders Eligible for Study: | Female |
Inclusion Criteria:
Contacts and Locations| Contact: Jane Alcantar | (800) 525-0245 | jalcant1@its.jnj.com |
| United States, California | |
| Mentor Worldwide LLC | |
| Santa Barbara, California, United States, 93111 | |
| Contact: Jane Alcantar 800-525-0245 jalcant1@its.jnj.com | |
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: | March 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
