The Double Capsule Phenomenon in a Case Series and its Relationship with the Macro-Textured Breast Implant.

[BACKGROUND] Silicone breast augmentation remains one of the most common aesthetic surgery procedures, and 2022 marks the 60th anniversary of the first case. Recent studies suggest a link between double capsule (DC) formation and macro-textured devices.

[METHODS] Between 2010 and 2015, 268 aesthetic patients underwent bilateral mammary prosthesis exchange for indications including PIP exchange, adverse capsular contracture and ultrasonographic evidence of rupture. All surgery, in the form of implant exchange and capsulectomy, was undertaken by the senior author using standard techniques. A retrospective review was undertaken, and data analysed with descriptive statistics and Fisher's exact and Mann-Whitney U tests.

[RESULTS] Of 268 patients identified, 40 (14.9%) showed some degree of capsular duplication and bilateral involvement was marginally more common (52.5%). Two macroscopic patterns of duplication were observed: complete and subtotal. Complete DCs correlated with a clinical triad of extreme firmness, mobility and minimal-to-no pain. Whilst a wide range of manufacturers was represented, macro-textured devices were associated with the highest DC prevalence (58.3% vs. 5.6%) (Fisher's exact test p < 0.00001). Patients with DC had been implanted for less than half the time, median 52 versus. 120 months (p = 0.0003) of those without.

[DISCUSSION] An elevated prevalence of duplicate capsules in macro-textured prostheses is reconfirmed in addition to a novel symptom constellation that may assist with clinical diagnosis. Our study reinforces the aetiopathogenic influence of the elastomer in DC formation and reports DC for the first time in non-macrotextured implants. Single-surgeon cohort of 268 consecutive patients with 532 implants Statistically significant association of macro-textured devices with DC Statistically significant reduced duration of implantation of macro-textured devices First report of DC in non-macro-textured devices LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .