Inclusion Criteria:
- Females age >18 and <65 years old. Women of childbearing potential must agree to use an acceptable method of contraception for one month prior to DCLNAC implantation, and until the graft is 100% healed. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap. Nonchildbearing potential for women is defined as postmenopausal (last natural menses greater than 12 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 12 months, a serum FSH value confirming post-menopausal status can be employed.
- Patient agrees to sleep on back until study tissue products are healed
- Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until study tissue products are healed
- Patient agrees to not undergo NAC tattooing until completing study
- Patient can understand and willing to sign informed consent
- Patient desires bilateral nipple reconstruction with DCLNAC
- Subjects must be capable of providing written informed consent to the study procedures and for use of protected health information \[Health Insurance Portability and Accountability Act (HIPAA), if applicable\]
Group A:
- Patient had a bilateral mastectomy with no radiation therapy
- Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Group B:
- Patient had a unilateral mastectomy with no radiation therapy
- Patient has undergone a unilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Group C:
- Patient had a bilateral mastectomy and received radiation unilaterally
- Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Group D:
- Patient had unilateral or bilateral mastopexy (with or without augmentation) or reduction mammaplasty and suffered nipple complications (i.e., necrosis, projection loss)
Group E:
- Patient had unilateral or bilateral mastectomy
- Patient had unilateral or bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
- Patient did not receive radiation to the autologously reconstructed breast
- Patient had unilateral or bilateral nipple reconstruction that failed (i.e., necrosis, projection loss)
Group F:
- Implant based reconstruction
Exclusion Criteria:
- Patient has a history of delayed wound healing
- Patient has a history of Vitamin C deficiency
- BMI<18.5 or >40 kg/m2
- Patient has a history of allergic reaction to any decellularized biologic matrix product
- Patient is currently smoking or using tobacco or nicotine products (i.e., patch, gum, vaping or nasal spray) or has used such products in the past 6 months
- Patient is currently receiving bilateral breast radiation or completed less than 3 months prior to screening
- Patient has any systemic disease that would impede wound healing, such as diabetes or connective tissue disorders
- Patient is pregnant, breastfeeding or planning to become pregnant during the study period
- Patient has any type of disease or disorder that in the investigator's opinion would make the patient unfit for the study, including active infection anywhere in the body.
- Acute mastitis in either breast
- History of an autoimmune disorder
- Use of any medications currently or in the past 3 months that would impair wound healing, such as long-term use of systemic steroids (inhaled, limited topical, short-term oral use and intra-articular steroids are acceptable)