Clarification About “Expert Consensus on the Use of a New Bioengineered, Cell-Friendly, Smooth Surface Breast Implant”

We applaud the authors for their efforts in trying to find a consensus among plastic surgery experts on the best clinical and surgical practices for Motiva Round and Ergonomix implants (Establishment Labs, Alajuela, Costa Rica).1 They convened a discussion and conducted a survey, compiling consensus recommendations by extracting expert opinions from the survey and collecting personal experiences and opinions via discussions. The workflow followed by the authors is far from being evidence based. A consensus conference to produce reliable recommendations for clinical practice should follow a strict pathway, beginning with the analysis of the evidence about the specific issue under investigation. The evidence could be analyzed and classified according to specific methods, like the Grading of Recommendations Assessment, Development and Evaluation method or the RAND/University of California at Los Angeles appropriateness method to synthesize the scientific literature and expert opinion on healthcare topics.2-8 The evidence on a specific scientific issue could only derive from published peer-reviewed literature, with a variable level of evidence according to Oxford Criteria and not only from a survey (even though among renowned experts, personal experiences, and opinions).9 A survey remains the opinion of a group of experts, without any evidenced base. This means that the recommendations presented in this paper only reflect the preferences of this group of experts and not the opinion of the experts on evidence deriving from literature. The authors refer to Popper’s falsifiability approach for the practice of science and we agree with it, but Popper’s theory does not affect the Galilean need for experimental evidence on which the scientific method is based, relying on intuition, demonstration, and experiment. Discussing about any topic will not lead to an evidence-based conclusion or recommendation if the discussion is based on personal observations not experimentally structured and not reproducible. The authors’ work remains a survey, that is, a list of questions aimed at extracting specific data from a particular group of surgeons. With a representative sample, a survey could describe the attitudes of the population from which the sample was drawn. The sample is, in this specific case, represented by 12 plastic surgeons with a variable experience with the utilization of Motiva devices, 1 biotechnologist who discussed surgical techniques and other issues relevant to these implants, and 36 plastic surgeons who received and answered an electronically delivered questionnaire via Survey Monkey. Inevitably and clearly, the results of this survey only represent the opinion of the 12 plastic surgeons who prepared the questions and the 36 who answered the questions. The authors should also clarify, discuss, and explain how and why this group of experts was selected for this task. Moreover, regarding the association between Motiva implants and breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) development, the follow-up experience of more than one-third of the plastic surgeons surveyed was less than 2 years. The evidence reported in the literature demonstrated the mean time for development of BIA-ALCL is 7 to 8 years and also 1 to 2 years does not represent a reliable follow-up for capsular contracture assessment.10 “Absence of evidence” about BIA-ALCL associated with these implants is not the same as “evidence of absence,” as the authors try to suggest. Furthermore, the authors present the surface of the Motiva implants as “nanoscale-structured, cell-friendly, smooth surface.” We think there is a discrepancy between the current standard to which implant manufacturers adhere (nano-, micro-, and macro-texturization) and the nomenclature utilized by fundamental metrology. Micro-, macro-, and nano-texturizations only remain advertising slogans, all market available texturizations being micro-texturizations (i.e., within the micrometer scale 1 × 10–6 of a meter) according to fundamental metrology. A clearer message is needed for the classification of Motiva surfaces, possibly referring to ISO guidelines 14607:2018.11 Lastly, the entire group of authors of this paper (except Dr Botti) disclose a relationship with Establishment Labs in terms of consulting agreements and membership of the Medical Advisory Board or the Scientific Advisory Board, and the article was supported by Establishment Labs, who also co-funded the development of the Journal Supplement. We think this represents sufficient conflict of interest to make the conclusion of this article at least questionable. It could be considered a sponsored paper, but this would not justify presenting a misleading message for the community of plastic surgeons; the authors need to underline how the data presented in the paper only represent the opinion of a small number of plastic surgeons without evidence deriving from the analysis of peer-reviewed published literature. Evidence about the outcomes of Motiva Implants will derive from adequate follow-up prospective studies, preferably randomized controlled trials, comparing these implants with other available breast prosthetic devices. Dr Nava is a temporary consultant for Allergan and Smith and Nephew. Dr Rancati is a worldwide advisor for Mentor. Dr de Vita is a temporary consultant for Galatea, Mentor, and Polytech. Drs Rocco and Catanuto declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. The authors received no financial support for the research, authorship, and publication of this article.