A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis

A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction

This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.

Inclusion Criteria:

1. Female 18 years or older
2. A candidate for immediate breast reconstruction during post-skin sparing or nipple-sparing mastectomy (unilateral or bilateral)
3. Estimated life expectancy > 2 years
4. Able and willing to return for all scheduled and required study visits
5. Able to provide written informed consent for study participation
6. Able to read, understand and complete study questionnaires

Exclusion Criteria:

1. Any of the conditions listed in the approved labeling as contraindicated
2. Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
3. Any patient that per the physician's judgement is not a good candidate for this study