High-intensity focused ultrasound for symptomatic breast fibroadenoma

Discomfort or burning sensation assessed with a visual analogue scale (VAS, 0=no pain, 10=very severe pain) was reported by 90% (18 out of 20) of women (mean score 6.4, standard deviation [SD] 3.2) treated by high-intensity focused ultrasound (HIFU) in a non-randomised controlled study of 40 women. In the same study, persistent pain assessed with a VAS was reported by 10% (2 out of 20) of women in the HIFU group (mean score 1.6, SD 1.9) within 3 months of treatment. Pain during treatment was reported as being slight in 36% (4 out of 11), moderate in 18% (2 out of 11) and severe in 9% (1 out of 11) of the procedures in a case series of 9 women (11 fibroadenomas) treated by magnetic resonance-guided HIFU. Pain after treatment measured by a VAS (0=no pain to 100=extreme pain) was 40.7 (±24.6) after the first ablation and 34.9 (±17.9) after the second ablation (p value not reported), in a case series of 20 patients treated by HIFU.

Numbness of the skin was reported by 1 woman of 20 treated by HIFU in the non-randomised controlled study of 40 women. Mild to moderate tenderness was reported by 45% (9 out of 20) of patients up to 1 week after the first HIFU session, and by 57% (4 out of 7) of patients after the second HIFU session in the case series of 20 patients.

Superficial skin burn with blistering was reported in 6% (3 out of 51) of fibroadenomas after the procedure in a case series of 42 women (51 fibroadenomas) treated by HIFU. A first-degree skin burn was reported in 1 woman of 20 treated by HIFU in the non-randomised controlled study of 40 women. A first-degree skin burn with hyperpigmentation visible after 6 months was reported in 1 woman of 7, who had more than 1 fibroadenoma, in the case series of 20 women treated by HIFU.

Hyperpigmentation of the skin was reported in 1 woman within days after the procedure in the case series of 42 women treated by HIFU. Hyperpigmentation of the skin was reported by 30% (6 out of 20) of women treated by HIFU at 3 months and 20% (4 out of 20) at 6 months in the non-randomised controlled study of 40 women.

Subcutaneous induration was reported in 1 woman of 42 at 12‑month follow-up in the case series of 42 women treated by HIFU. Subcutaneous oedema was reported in 25% (4 out of 20) of women in the case series of 20 women treated by HIFU.

Ecchymosis was reported by 45% (9 out of 20) of women treated by HIFU in the non-randomised controlled study of 40 women.

Erythema was reported by 30% (6 out of 20) of women treated by HIFU in the non-randomised controlled study of 40 women. Mild to moderate erythema that resolved within 1 week was reported by 29% (2 out of 7) of women, who had more than 1 fibroadenoma, treated by HIFU in the case series of 20 patients.

Dimpling of the skin was reported by 1 woman of 20 treated by HIFU in the non-randomised controlled study of 40 women.

In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed no anecdotal adverse events. They considered that the following were theoretical adverse events: poor cosmetic outcome, infection and severe fibrosis.