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

DOI:10.1093/asj/sjz176
Authors:
Maurizio Bruno Nava
Maurizio Bruno Nava
Maurizio Bruno Nava
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Alberto Rancati at Universidad de Buenos Aires
Alberto Rancati
Roy De Vita at Istituto Regina Elena - Istituti Fisioterapici Ospitalieri
Roy De Vita
Giuseppe Catanuto at Scuola di Oncologia Chirurgica Ricostruttiva
Giuseppe Catanuto
  • Scuola di Oncologia Chirurgica Ricostruttiva
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MB Nava1,2, A Rancati3, R De Vita4 , G Catanuto 2,5, N Rocco 2,6
1 University of Milan, Milan, Italy
2 G.RE.T.A. Group for Reconstructive and Therapeutic Advancements, Milan, Naples,
Catania, Italy
3 Chief Oncoplastic Surgery, Instituto Henry Moore, University of Buenos Aires,
Argentina
4 Department of Plastic Surgery National Cancer Institute “Regina Elena”, Rome,
Italy
5 Multidisciplinary Breast Unit, Azienda Ospedaliera Cannizzaro, Catania, Italy
6 Department of Clinical Medicine and Surgery, University of Naples “Federico II”,
Naples, Italy
Corresponding Author
Nicola Rocco, MD
University of Naples “Federico II”
Via Sergio Pansini 5
80131 Naples, Italy
telephone 0039 0817462515; e-mail: nicola.rocco@greta-oncoplastic.com
Dear Editor,
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 (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 GRADE method (2-7) or the RAND/UCLA
appropriateness method to synthesize the scientific literature and expert opinion on
health care topics (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 (9)
and not only from a survey (even though among renowned experts), personal
experiences and opinions. The last remain the opinions 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 use of Motiva devices and 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 and the 36 who answered the
questions. The authors should also clarify, discuss and motivate how and why this
group of experts was selected for this task.
Moreover, regarding some particular issues, like the association between Motiva
implants and BIA-ALCL development, the experience in terms of follow-up of more
than 1 third of the plastic surgeons who were asked to answer the questions was less
than 2 years and evidence reported in literature demonstrated how the mean time for
development of BIA-ALCL is 7-8 years (10) and 1-2 years does not represent a
reliable follow-up for capsular contracture assessment as well.
“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 that 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 (that is within the micrometer
scale 1 x 10-6 of a meter) according to fundamental metrology. A clearer message is
needed according the classification of Motiva surfaces, possibly referring to ISO
guidelines 14607:2018 (11).
Last but not least, the entire group of authors of this paper (but Dr. Botti) disclose a
relationship with Establishment Labs, in terms of consulting agreements, membership
of the Medical Advisory Board or the Scientific Advisory Board and the article was
supported by Establishments Labs (Alajuela, Costa Rica), 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 could not justify presenting a
misleading message for the community of plastic surgeons, with the need for the
authors 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, better if randomized controlled trials, comparing these
implants to other available breast prosthetic devices.
References
1. Sforza M, Hammond DC, Botti G, Heden P, Chacon Quiros M, Mendonca Munhoz
A, Kinney BM, Corduff N. Expert Consensus on the use of a new bioengineered,
cell-friendly, smooth surface breast implant. Aesthertic Surgery Journal 2019. 39
(S3): S95-102.
2.Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating
quality of evidence and strength of recommendations. BMJ 2008;336:924–6.
3.Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE
evidence profiles and summary of findings tables. J Clin Epidemiol 2011;64:383–94.
4. Alonso-Coello P, Schünemann HJ, Moberg J, et al. GRADE Evidence to Decision
(EtD) frameworks: a systematic and transparent approach to making well informed
healthcare choices. 1: Introduction. BMJ 2016;353:i2016
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frameworks: a systematic and transparent approach to making well informed
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evidence to recommendations: the significance and presentation of recommendations.
J Clin Epidemiol 2013;66:719–25.
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quality of evidence. J Clin Epidemiol 2011;64:401–6.
8. https://www.rand.org/health-care/surveys_tools/appropriateness.html. Last
accessed 14th April 2019.
9. https://www.cebm.net/2009/06/oxford-centre-evidence-based-medicine-levels-
evidence-march-2009/. Last accessed 14th April 2019.
10. de Boer M, van Leeuwen FE, Hauptmann M, Overbeek LIH, de Boer JP,
Hijmering NJ, Sernee A, Klazen CAH, Lobbes MBI, van der Hulst RRWJ, Rakhorst
HA, de Jong D. Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in
the Breast. JAMA Oncol. 2018; 4(3):335-341.
11. https://www.iso.org/standard/63973.html. Last accessed 14th April 2019.
... Current available data on these implants are mostly from noncontrolled case series and non-evidence-based "consensus" among experts. [4][5][6][7][8][9][10] Moreover no data comparing so-called nanotextured breast implants with smooth implants are available in the literature. It would be advisable to compare these implants in a controlled study to better understand the performance and outcome of these devices. ...
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... The previous literature, with short follow-ups and no control groups, did not resolve my doubt. [1][2][3][4][5] According to the present results, nanotextured implants do not perform better than textured implants, which makes my early skepticism more prominent than ever. ...
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... We understand that terminologies as nano-texturization, micro-texturization, or macro-texturization should not necessarily reflect that of metrology but only represent a comparison between different types of texturization and remain advertising slogans, but this could lead to misinterpretations. 12 We know that all market available textures are microtexturizations according to metrology, but the ISO Classification (14607:2018) itself uses the terms of "smooth" surfaces for roughness (Ra) <10 µm, "microtextured" for Ra from 10 to 50 µm, and "macrotextured" for Ra >50 µm. 13 In conclusion, we believe that the impact of implants textures on the etiology of capsular contracture and BIA-ALCL is far form being defined, as if we believe to the biofilm theory and to the association of texturization with higher bacterial growth and biofilm formation, we should also have evidences of higher risk of capsular contracture with textured implants use. ...
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... permissions@oup.com Aesthetic Surgery Journal 2019, [1][2][3] In April 2018, the International Organization of Standardization (ISO) published a new version of ISO-14607 "Non-active surgical implants-Mammary implants-Particular requirements" 7 (the "Standard"). Annex H, "Test for surface characteristic," states that the objective of adding a description of a surface is to generate data to improve knowledge on the correlation between breast implant surface characteristics, performance, and safety. ...
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Expert Consensus on the Use of a New Bioengineered, Cell-Friendly, Smooth Surface Breast Implant
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Full-text available
  • Apr 2019
Background Although general guidelines are available for established silicone gel breast implants, the unique characteristics of the latest Motiva implants warrant specific guidelines. Objectives This study aimed to generate consensus recommendations and summarize expert-based advice to better understand current surgical practices and to establish guidelines for surgeons transitioning from other implant devices to the Motiva implants. Methods A survey was compiled by 12 plastic surgeon experts in aesthetic and reconstructive breast surgery and 1 biotechnology scientist, and distributed to 36 plastic surgeons to establish a consensus on the use of these devices. Surgical techniques, complication rates, and implant selection were among the topics discussed. Results The experts agreed on 3 core principles regarding the use of Motiva Round and Ergonomix implants. Firstly, the dissected pocket needs to be close fitting and steps must be taken to prevent expansion of the pocket. Secondly, implant selection must be individualized. Finally, surgical planning and technique must be carefully considered. When questioned about problems they had ecountered, 84.6% of the experts agreed that they experienced fewer overall complications and 76.9% confirmed reduced capsular contracture rates with these devices. Overall, 84.6% of the experts favored selecting Motiva Ergonomix implants over Round implants to achieve a more natural look. In addition, 92.3% of the experts agreed that Motiva implants, due to their innovative technology, reduce the risk of anaplastic large-cell lymphoma. Conclusions This international consensus of leading practitioners will assist plastic surgeons with patient selection, preoperative planning, and surgical technique. These recommendations are designed to optimize surgical outcomes, resulting in lower overall complication rates, more natural-looking breasts, and highly satisfied patients.
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GRADE Evidence to Decision (EtD) frameworks: A systematic and transparent approach to making well informed healthcare choices. 1: Introduction
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GRADE: An emerging consensus on rating quality of evidence and strength of recommendations
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Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast
Article
  • Jan 2018
Importance Breast implants are among the most commonly used medical devices. Since 2008, the number of women with breast implants diagnosed with anaplastic large-cell lymphoma in the breast (breast-ALCL) has increased, and several reports have suggested an association between breast implants and risk of breast-ALCL. However, relative and absolute risks of breast-ALCL in women with implants are still unknown, precluding evidence-based counseling about implants. Objective To determine relative and absolute risks of breast-ALCL in women with breast implants. Design, Setting, and Participants Through the population-based nationwide Dutch pathology registry we identified all patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and retrieved clinical data, including breast implant status, from the treating physicians. We estimated the odds ratio (OR) of ALCL associated with breast implants in a case-control design, comparing implant prevalence between women with breast-ALCL and women with other types of breast lymphoma. Cumulative risk of breast-ALCL was derived from the age-specific prevalence of breast implants in Dutch women, estimated from an examination of 3000 chest x-rays and time trends from implant sales. Main Outcomes and Measures Relative and absolute risks of breast-ALCL in women with breast implants. Results Among 43 patients with breast-ALCL (median age, 59 years), 32 had ipsilateral breast implants, compared with 1 among 146 women with other primary breast lymphomas (OR, 421.8; 95% CI, 52.6-3385.2). Implants among breast-ALCL cases were more often macrotextured (23 macrotextured of 28 total implants of known type, 82%) than expected (49 193 sold macrotextured implants of total sold 109 449 between 2010 and 2015, 45%) based on sales data (P < .001). The estimated prevalence of breast implants in women aged 20 to 70 years was 3.3%. Cumulative risks of breast-ALCL in women with implants were 29 per million at 50 years and 82 per million at 70 years. The number of women with implants needed to cause 1 breast-ALCL case before age 75 years was 6920. Conclusions and Relevance Breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants.
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