DuraSorb® in Prosthetic Breast Reconstruction

Exclusion Criteria

• •Is pregnant or planning to become pregnant during study participation
• •Has a history of failed tissue expansion or breast implantation at the intended reconstruction site
• •has a residual gross tumor at the intended reconstruction site
• •has been treated for a systemic infection or a local infection at the surgical site that the investigator determines will affect the safety of the subject during breast reconstruction and/or mesh use
• •has, as determined by the investigator, unsuitable tissue integrity for immediate 2-stage breast reconstruction
• •has undergone previous radiation therapy to the reconstruction site or chest wall
• •is scheduled to undergo post-operative radiation therapy at the reconstruction site
• •has a Body Mass Index (BMI) \< 14 or \> 44
• •has used nicotine products within 90 days of screening
• •is currently taking medications including non-NSAID anti-coagulants, immunosuppressants (including systemic steroids), or other medications determined by the investigator to place the subject at an increased risk of local complications of breast reconstruction
• •has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
• •has participated in any other clinical study that the investigator feels may interfere with this clinical study