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Compassionate Use of the Becker Expander/Breast Implant

2014-07-23 21:12:22 | BioPortfolio

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

Study Design

N/A

Conditions

Breast Reconstruction

Intervention

Becker 50 Expander/Breast implant, Becker 25 Expander/Breast implant

Location

Mentor Corporation
Santa Barbara
California
United States
93111

Status

Available

Source

Mentor Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:22-0400

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Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction

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Medical and Biotech [MESH] Definitions

A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.

Insertion of an implant into the bone of the mandible or maxilla. The implant has an exposed head which protrudes through the mucosa and is a prosthodontic abutment.

A common and benign breast disease characterized by varying degree of fibrocystic changes in the breast tissue. There are three major patterns of morphological changes, including FIBROSIS, formation of CYSTS, and proliferation of glandular tissue (adenosis). The fibrocystic breast has a dense irregular, lumpy, bumpy consistency.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

A muscle protein localized in surface membranes which is the product of the Duchenne/Becker muscular dystrophy gene. Individuals with Duchenne muscular dystrophy usually lack dystrophin completely while those with Becker muscular dystrophy have dystrophin of an altered size. It shares features with other cytoskeletal proteins such as SPECTRIN and alpha-actinin but the precise function of dystrophin is not clear. One possible role might be to preserve the integrity and alignment of the plasma membrane to the myofibrils during muscle contraction and relaxation. MW 400 kDa.

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