Researchers conducted a study to evaluate the short-term clinical outcomes of varying approaches to immediate implant-based breast reconstruction in the UK.
Implant-based breast reconstruction at the time of mastectomy, using biological or synthetic mesh or other techniques, had a high rate of complications in a large study in the United Kingdom. Further studies are needed to determine the best approach for immediate implant-based reconstruction.
“Up to 40% of the 1.7 million women diagnosed with breast cancer each year will require a mastectomy as the surgical treatment for their disease,” wrote study authors led by Shelley Potter, PhD, of Bristol Medical School in the UK. “Mastectomy can profoundly affect body image and self-esteem, and immediate breast reconstruction, performed at the time of mastectomy, is offered to improve quality of life.”
Traditional approaches to reconstruction involved a two-stage procedure, but the introduction of biological and synthetic meshes has changed this, with only a one-stage procedure required. “Despite the widespread adoption of mesh-assisted techniques into practice, evidence to support the proposed benefits of mesh is lacking,” the authors wrote. The new study was part of the four-stage implant Breast Reconstruction evAluation (iBRA); following a national practice questionnaire, the researchers conducted a prospective multicenter study to evaluate the short-term clinical outcomes of varying approaches to immediate implant-based breast reconstruction in the United Kingdom. The results were published in Lancet Oncology.
The study included 2,108 patients, 27 of whom were lost to follow-up. Biological mesh-assisted reconstruction was the most common procedure, in 1,133 patients (54%); 243 patients had synthetic mesh-assisted reconstruction (12%), and 181 patients had traditional subpectoral reconstruction without the use of mesh (9%). Another 440 patients had subpectoral reconstruction with a dermal sling (21%), and small numbers of patients underwent less common procedures.
Among the full cohort, 370 patients (18%) required a reoperation within 3 months; the National Quality Criteria for Breast Reconstruction specify a reoperation rate of under 5%. Hospital readmission was required in 372 patients (18%), and the standards again specify under 5%. A total of 522 patients (25%) experienced an infection, compared with a standard of under 10%, and 182 patients (9%) had implant loss, compared with the standard of under 5%.
A multivariate analysis found that higher body mass index was associated with all negative outcomes, as was smoking.
“There remains the need for high-quality evidence from a randomized controlled trial to support the best practice of immediate implant-based breast reconstruction, and the equivalence of different techniques in this non-randomized study supports a future randomized clinical trial,” the authors concluded. “The outcomes of immediate implant-based breast reconstruction in the UK are poor and surgeons need to commit to robust evaluation if outcomes for patients are to be improved.”
In an accompanying editorial, Nicola Rocco, MD, PhD, and Giuseppe Catanuto, MD, PhD, both of the Group for Reconstructive and Therapeutic Advancements in Milan, Italy, wrote that “these worrisome conclusions could be a direct consequence of the poor evidence available to inform choices about the best method of reconstruction to use, which generates unreliable and confusing information about indications, risk factors, and outcomes.” They highlighted the high rate of infection, and suggested an analysis based on the use of antibacterial prophylaxis is warranted.
Rocco and Catanuto noted that while large randomized trials are clearly needed to clarify best practices in this arena, the best clinical approach in the meantime may be to use preoperative systemic treatment as a potential way to reduce the number of mastectomies required. The new study, though, “will hopefully clarify the status quo, and improve outcomes through a proper and evidence-based patient selection.”