Table 4

Breast Device Registry minimum dataset

IdentifiersDemographic details: patient identifiers including contact person information.
Device details: device batch identifiers; manufacturer; and distributor.
Site details: identifying physically separate operating theatres, via name and address.
Surgeon details: name of primary operating surgeon.
Additional factorsPatient history: reason for primary operation; description of the operation; previous radiotherapy.
Elements of operation: incision site; plane; mastopexy; use of mesh or acellular dermal matrix; use of fat grafting; tissue expander intraoperative fill volume.
Additional intraoperative techniques: antiseptic rinse; antibiotic solution; prophylactic antibiotics; drains; sleeve/funnel (Keller funnel); nipple guards; glove change for insertion.
Revision operation details: description of operation; capsulectomy.
Complications causing or found during revision surgery: removal of PIP; removal of overseas implant; device rupture; device deflation; capsular contracture; silicone extravasation; device malposition; skin scarring problems; deep wound infection; seroma/haematoma; breast cancer; anaplastic large cell lymphoma.