Title
The Safety and Effectiveness of DuraSorb® for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction

Description
Plastic surgeons have a variety of biologic and synthetic mesh available for use. However, no mesh has adequately evaluated safety and effectiveness for FDA approval or clearance for use in breast reconstruction. Therefore, no mesh is an appropriate comparator for a randomized clinical study.

This multi-center, prospective, clinical study with matched historical controls of total submuscular 2-stage breast reconstructions with no mesh will evaluate the safety and effectiveness of DuraSorb® monofilament surgical mesh when implanted in subjects undergoing 2-stage breast reconstruction.

Women scheduled for mastectomy and immediate 2-stage breast reconstruction will sign informed consent and satisfy eligibility criteria prior to the first stage of surgery and DuraSorb® implantation.

Maximum study follow-up is through one year after definitive reconstruction.

Objective
This is a multi-center, comparative, interventional clinical study to evaluate the safety and effectiveness of DuraSorb® when implanted in subjects undergoing 2-stage breast reconstruction to support the tissue expander, vs. matching historical controls with no mesh. Retrospective medical chart screening of patients who have undergone 2-stage breast reconstruction with no mesh will be performed at all participating study sites to obtain these matching controls.

Treatment Experimental: Treatment Arm
Device: DuraSorb®
Monofilament Surgical Mesh

Key Eligibility 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

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 within 30 days prior to surgery

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

Applicable Disease Sites
Breast

Participating Institutions
UW Health University Hospital : Surgery Coordinator Contact