Bilateral PROphylactic mastectomy; Should we preserve the pectoral FAScia? - PROFAS 1

INTERVENTION: A double blinded, prospective, randomized controlled pilot‐study with a within‐subject design, will be performed. Patients will be asked to participate at the outpatient clinic of the Erasmus MC, Cancer Institute. Bilateral prophylactic mastectomies will be performed in the Erasmus MC. Randomization will occur between breasts within the patient. One of the breasts will be the intervention which contains the preservation of the pectoral fascia versus the other breast, which will be the control with conventional surgery and thereby removal of the pectoral fascia. Patients will be blinded for randomization. CONDITION: Female BRCA 1 or 2 gene mutation carries, bilateral prophylactic mastectmy, pectoral fascia preservation, seroma production PRIMARY OUTCOME: To evaluate to feasibility of a full‐scale study. SECONDARY OUTCOME: Impact of removal versus preservation of the pectoral fascia on seroma formation. Seroma is defined as any clinically detected collection of fluid requiring aspiration. The drain production and the number of days the drain will be left in situ will be measured. The volume of 30 ml in 24 hours is established as a guideline for timing of drain removal. ; Impact of removal versus preservation of the pectoral fascia on postoperative pain, wound related issues as hematoma and infection, and hospitalization duration. INCLUSION CRITERIA: Woman > 18 years, presenting in the Academic Breast Cancer Center Rotterdam, who are opting for bilateral prophylactic mastectomy are eligible for the study.