Strategic priorities impacted study

The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.

Inclusion Criteria:

• Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant
• Be female, between 18 and 65 years of age at the time of enrollment

Exclusion Criteria:

• Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study
• Have undergone a skin reducing mastectomy
• Have a BMI that is <17 or ≥ 30
• Predicted implant weight more than 500 grams
• Have a known allergy to silk
• Have an abscess or active infection at any location within one month prior to surgery
• Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study