Short-Term Safety Outcomes in Mastectomy and Immediate Implant-Based Breast Reconstruction


Key Points

  • Overall, 9% of patients had loss of implants, 18% required hospital readmission, 18% required return to surgery for complications within 3 months of initial surgery, and 25% required treatment for infection.
  • Rates of all these complications exceeded national standards.

In a prospective cohort study reported in The Lancet Oncology, Potter et al found that complications following immediate implant-based breast reconstruction—with or without mesh—were higher than considered acceptable by UK national standards. As noted by the investigators, the study was aimed at establishing the short-term safety of immediate implant-based breast reconstruction performed with and without mesh in order to assess the feasibility of a future randomized trial comparing breast reconstruction techniques.

Study Details

The study involved data from consecutively recruited women aged ≥ 16 years who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction with any technique at 81 breast and plastic surgical units in the UK. Outcomes of interest were implant loss (unplanned removal of expander or implant), infection requiring antibiotic treatment or surgery, unplanned return to surgery, and unplanned readmission to hospital for complications up to 3 months after reconstruction.

Techniques Used and Complication Rates

Between February 2014 and June 2016, 2,108 women had 2,655 mastectomies with immediate implant-based breast reconstruction at the 81 sites. Among these, 1,650 (78%) had planned single-stage reconstructions, 1,376 (65%) had reconstruction with biologic (1,133; 54%) or synthetic (243; 12%) mesh, 181 (9%) had nonmesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had prepectoral implants, and 79 (4%) had other or a combination of implants.

Outcome data at 3 months were available for 2,081 patients (99%). Among these, 182 (9%) had loss of implants, 372 (18%) required hospital readmission, 370 (18%) required return to surgery for complications within 3 months of initial surgery, and 522 (25%) required treatment for infection.

As stated by the investigators, the rates of all complications were higher than those stipulated in National Quality Standards—ie, < 5% for reoperation, readmission, and implant loss, and < 10% for infection. Age, neoadjuvant chemotherapy, bilateral surgery, indication for surgery, nipple-sparing procedures, insertion of a definitive fixed-volume implant, and type of reconstruction performed were not significant risk factors for any of the safety outcomes of interest.

The investigators concluded, “Complications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomized clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction.”

Shelley Potter, PhD, of the Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, is the corresponding author for The Lancet Oncology article.

Disclosure: The study was funded by the National Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons. The study authors’ full disclosures can be found at

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