DuraSorb® in Prosthetic Breast Reconstruction

Inclusion Criteria

• Female between the inclusive ages of 22 and 70 at the time of initial expander surgery
• Scheduled to undergo either unilateral or bilateral mastectomy with immediate 2-stage breast reconstruction
• Is able to understand the study requirements and is willing to provide written informed consent
• Is willing and able to return for all scheduled study visits

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