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,
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”,
Nicola Rocco, MD
University of Naples “Federico II”
Via Sergio Pansini 5
80131 Naples, Italy
telephone 0039 0817462515; e-mail: email@example.com
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
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. https://www.rand.org/health-care/surveys_tools/appropriateness.html. 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. https://www.iso.org/standard/63973.html. Last accessed 14th April 2019.