Compassionate Use of the Becker Expander/Breast Implant

Mentor Worldwide

Status

Conditions: Breast Reconstruction

Treatments: Device: Becker 50 Expander/Breast implant; Device: Becker 25 Expander/Breast implant

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01000012

A101-0501-08cu

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Women who require a Becker Expander/Breast implant who do not meet inclusion/exclusion criteria of the Becker Continued Access Study