Identifiers | Demographic 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 factors | Patient 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. |