Is It All about Surface Topography? An Intra-Individual Clinical Outcome Analysis of Two Different Implant Surfaces in Breast Reconstruction

Abstract

The most common long-term complication of silicone breast implants (SMI) remains capsular fibrosis. The etiology of this exaggerated implant encapsulation is multifactorial but primarily induced by the host response towards the foreign material silicone. Identified risk factors include specific implant topographies. Of note, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has only been observed in response to textured surface implants. We hypothesize that reduction of SMI surface roughness causes less host response and, hence, better cosmetic outcomes with fewer complications for the patient. A total of 7 patients received the routinely used CPX®4 breast expander (~60 µM Ra) and the novel SmoothSilk® (~4 µM Ra), fixed prepectoral with a titanized mesh pocket and randomized to the left or right breast after bilateral prophylactic NSME (nipple-sparing mastectomy). We aimed to compare the postoperative outcome regarding capsule thickness, seroma formation, rippling, implant dislocation as well as comfortability and practicability. Our analysis shows that surface roughness is an influential parameter in controlling fibrotic implant encapsulation. Compared intra-individually for the first time in patients, our data confirm an improved biocompatibility with minor capsule formation around SmoothSilk® implants with an average shell roughness of 4 µM and in addition an amplification of host response by titanized implant pockets.

Silicone implant surface microtopography modulates inflammation and tissue repair in capsular fibrosis

“…Our data aligns with our previous observation of a notably thicker capsule around the rougher device compared to SMI 4 µm ( 26 ). To probe implant surface roughness effects on capsular composition, we conducted immune profiling of intracapsular immune cells through flow cytometry ( Supplementary Figure S7 ) and immunohistology on capsules harvested bilaterally 6-8 months post-implantation ( Figure 6A ).…”

“…Implants with a 4 µm average roughness resulted in the least inflammation and fibrous scar tissue ( 25 ). Our latest patient data corroborates improved biocompatibility with minor capsule formation around 4 µm roughness implants ( 26 ).…”

“…As described previously in ( 13 , 26 ), this study comprised 10 female patients who underwent simultaneous prophylactic bilateral nipple-sparing mastectomy (NSME) and tissue expander-based breast reconstruction ( Figure 1 ). Written informed consent was obtained from all patients after confirming their eligibility based on the in-and exclusion criteria ( Table 1 ).…”

“…Therefore, 14 peripheral blood draws (7 patients x 2 surgeries), 70 WBF samples (7 patients x 5 days post-op x 2 tissue expander types), 28 capsular tissue specimens (7 patients x 5 days post-op x 2 tissue expander types x 2 sampling locations) and 14 tissue expander surface strips (7 patients x 2 expanders) were evaluated. For a detailed description of the study population see Schoberleitner et al., 2023 ( 13 , 26 ).…”

“…The inflatable tissue expanders were exchanged for definite implants in a second surgery, 6 to 8 months post-implantation. For detailed description of the study design see Schoberleitner et al., 2023 ( 13 , 26 ).…”