Real-world data of perioperative complications in prepectoral implant-based breast reconstruction: a prospective cohort study.

Purpose: To analyze complications and potential risk factors associated with immediate prepectoral direct-to-implant breast reconstruction (DTIBR).

Methods: 295 patients (326 operated breasts) with DTIBR between March 2021 and December 2023 were included in this prospective study. Postoperative complications (postoperative bleeding, seroma, infection, necrosis, wound dehiscence, implant exchange/loss) were analyzed for potential risk factors by descriptive and logistic regression analyses.

Results: The implant was covered by TiLOOP® Bra Pocket in 227 breasts (69.6%), by "dual-plane" technique in 20 breasts (6.1%), by acellular dermal matrix (ADM) in 1 breast (0.3%). No additional support was used for 78 breasts (23.9%). The use of mesh did not increase the risk for complications. Major complications requiring surgical revision occurred due to postoperative bleeding in 22 (6.7%), seroma in 2 (0.6%), infection in 13 (4.0%), necrosis in 10 (3.1%), and wound dehiscence in 10 (3.1%) breasts. Thirteen (4.0%) implants were exchanged, and 5 (1.5%) were explanted without substitution. One patient had to switch to autologous reconstruction due to skin necrosis. The main reasons for the removal/exchange of implants were infections (11 breasts, 3.4%) and necrosis (4 breasts, 1.2%). The risk for necrosis, infection, and wound dehiscence was mainly associated with the type of incision, especially skin-reducing incisions, and body mass index (BMI) ≥ 30 kg/m².

Conclusion: Severe complications occurred primarily in patients with a BMI ≥ 30 kg/m² and when skin-reducing surgical techniques were performed.

Trial registry: This study was retrospectively registered at the German Clinical Trials Register (DRKS) on 20.06.2024.

Drks-id: DRKS00034493. https://drks.de/search/de/trial/DRKS00034493 .