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

  • Scuola di Oncologia Chirurgica Ricostruttiva
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,
4 Department of Plastic Surgery National Cancer Institute “Regina Elena”, Rome,
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:
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.
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
5. Alonso-Coello P, Oxman AD, Moberg J, et al. GRADE Evidence to Decision (EtD)
frameworks: a systematic and transparent approach to making well informed
healthcare choices. 2: Clinical practice guidelines. BMJ 2016;353:i2089
6. Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines: 14. Going from
evidence to recommendations: the significance and presentation of recommendations.
J Clin Epidemiol 2013;66:719–25.
7. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the
quality of evidence. J Clin Epidemiol 2011;64:401–6.
8. Last
accessed 14th April 2019.
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. 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. ...
... 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. ...
... 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. ...
... 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. ...
Background It would be mandatory for plastic surgeons to consider anthropometric and anatomical differences between Asians and Caucasians in performing facial rejuvenation procedures using absorbable threadlifts in Asians. Methods A consensus meeting was convened to discuss indications, treatment procedures, possible combination treatments, clinical outcomes and safety of an absorbable polydioxanone (PDO) monofilament threadlift (Mint Lift®; HansBiomed Co. Ltd., Seoul, Korea), for which the “Mint Aesthetics Expert Group” was organized with four Korean board‐certified specialists in plastic and reconstructive surgery. Results Our recommendations are as follows: First, the entry and exit points should be determined considering anatomical characteristics of the face (Level of evidence III). Second, treatment procedures may vary depending on indications (Level of evidence III). Third, short‐term efficacy and safety of facial rejuvenation using the Mint Lift® have been well documented (Level of evidence I and III). Third, facial rejuvenation using the Mint Lift® may be combined with a liposuction (Level of evidence III). Conclusions Here, we propose expert consensus on facial rejuvenation using a novel absorbable PDO monofilament threadlift in Koreans. Of note, this is the only expert consensus prepared by board‐certified specialists in plastic surgery in Korea. But more evidence‐based efforts should be made to update and to expand the current recommendations.
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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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#### Summary points Healthcare decision making is complex. Decision-making processes and the factors (criteria) that decision makers should consider vary for different types of decisions, including clinical recommendations, coverage decisions, and health system or public health recommendations or decisions.1 2 3 4 However, some criteria are relevant for all of these decisions, including the anticipated effects of the options being considered, the certainty of the evidence for those effects (also referred to as quality of evidence or confidence in effect estimates), and the costs and feasibility of the options. Decision makers must make judgments about each relevant factor, informed by the best evidence that is available to them. Often, the processes that decision makers use, the criteria that they consider and the evidence that they …
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Guidelines are inconsistent in how they rate the quality of evidence and the strength of recommendations. This article explores the advantages of the GRADE system, which is increasingly being adopted by organisations worldwide Summary points Failure to consider the quality of evidence can lead to misguided recommendations; hormone replacement therapy for post-menopausal women provides an instructive example High quality evidence that an intervention’s desirable effects are clearly greater than its undesirable effects, or are clearly not, warrants a strong recommendationUncertainty about the trade-offs (because of low quality evidence or because the desirable and undesirable effects are closely balanced) warrants a weak recommendationGuidelines should inform clinicians what the quality of the underlying evidence is and whether recommendations are strong or weakThe Grading of Recommendations Assessment, Development and Evaluation (GRADE ) approach provides a system for rating quality of evidence and strength of recommendations that is explicit, comprehensive, transparent, and pragmatic and is increasingly being adopted by organisations worldwideGuideline developers around the world are inconsistent in how they rate quality of evidence and grade strength of recommendations. As a result, guideline users face challenges in understanding the messages that grading systems try to communicate. Since 2006 the BMJ has requested in its “Instructions to Authors” on that authors should preferably use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system for grading evidence when submitting a clinical guidelines article. What was behind this decision?In this first in a series of five articles we will explain why many organisations use formal systems to grade evidence and recommendations and why this is important for clinicians; we will focus on the GRADE approach to recommendations. In the next two articles we will examine how the GRADE system categorises quality of evidence and strength of recommendations. The final two articles will …
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.
This article introduces the approach of GRADE to rating quality of evidence. GRADE specifies four categories-high, moderate, low, and very low-that are applied to a body of evidence, not to individual studies. In the context of a systematic review, quality reflects our confidence that the estimates of the effect are correct. In the context of recommendations, quality reflects our confidence that the effect estimates are adequate to support a particular recommendation. Randomized trials begin as high-quality evidence, observational studies as low quality. "Quality" as used in GRADE means more than risk of bias and so may also be compromised by imprecision, inconsistency, indirectness of study results, and publication bias. In addition, several factors can increase our confidence in an estimate of effect. GRADE provides a systematic approach for considering and reporting each of these factors. GRADE separates the process of assessing quality of evidence from the process of making recommendations. Judgments about the strength of a recommendation depend on more than just the quality of evidence.
This article is the first of a series providing guidance for use of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system of rating quality of evidence and grading strength of recommendations in systematic reviews, health technology assessments (HTAs), and clinical practice guidelines addressing alternative management options. The GRADE process begins with asking an explicit question, including specification of all important outcomes. After the evidence is collected and summarized, GRADE provides explicit criteria for rating the quality of evidence that include study design, risk of bias, imprecision, inconsistency, indirectness, and magnitude of effect. Recommendations are characterized as strong or weak (alternative terms conditional or discretionary) according to the quality of the supporting evidence and the balance between desirable and undesirable consequences of the alternative management options. GRADE suggests summarizing evidence in succinct, transparent, and informative summary of findings tables that show the quality of evidence and the magnitude of relative and absolute effects for each important outcome and/or as evidence profiles that provide, in addition, detailed information about the reason for the quality of evidence rating. Subsequent articles in this series will address GRADE's approach to formulating questions, assessing quality of evidence, and developing recommendations.