PONE-D-20-00357

Silicone Induced Granuloma of Breast Implant Capsule (SIGBIC) diagnosis: Breast Magnetic Resonance (BMR) ability to detect silicone bleeding.

PLOS ONE

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Reviewers' comments:

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Comments to the Author

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Reviewer #1: Partly

Reviewer #2: Partly

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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Reviewer #1: No

Reviewer #2: Yes

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5. Review Comments to the Author

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Reviewer #1: General impression:

the topic of this manuscript is relevant and is approached with a strong clinical focus. It is a niche rather than a mainstream topic. The authors are preparing their material very comprehensively. They can rely on a very large expertise and number of patients.

I am convinced that the material and the core message are worthy of publication. However, in my opinion this is difficult to do in the current form of the manuscript.

First of all, this is due to the language style: there are many difficult to understand phrases.

In addition, the structure often does not follow the established criteria of such studies. For example, the rational is only defined late in the material and methods section. Explanations that belong in the latter are presented in results and so on. a restructuring and rewriting according to STARD criteria is strongly recommended.

In addition, I think the analysis of the data is too complex and the presentation of the results is hardly comprehensible. In the end, the statement is simple. Can we make a reliable diagnosis with additional diagnostic criteria? If so, how exactly? On the other hand, there are too many and too complex analyses, the details even appear to be erroneous (percentages Table 1) and in some cases are not necessary to convey the message of the authors. More important details such as the multivariate model and the ROC curve, however, are not mentioned at all.

Detailed comments

The abstract should be shortened . The methods have to be better defined here and the rational has to be better explained.

In the M&M, the setting of the hospital according to the STARD criteria should be better explained.

A clear description of the mri protocol is missing

I find the image material well prepared, however, on page 14, line 116 ff. the features should be supplemented with an example image + schematic drawing

Examples of incomprehensible wording can be found on page 15, lines 198 and 199

I do not consider it appropriate to set alpha at 25%.

in order to better examine the accuracy of the criteria, I suggest that patients +/- SICBIG to be analysed more consistently

The three patients who had to be excluded should be described in more detail

confusing is the moderate accuracy of multivariate models in the context of the otherwise very optimistic univariate results

Reviewer #2: The paper is nicely written but I would suggest to better emphasize what should be the clinical consequence of these findings. I also find quite difficult to justify that the authors performed percutaneous breast biopsy or even capsulectomy for no suspicious findings, especially considering the risk to damage the implant. I would also suggest to improve the figure descriptions that are quite crucial to understand what the authors refer to.

Introduction

“However, gel bleeding is virtually ignored by the academy as a trigger point for these changes. Most articles advocate that gel bleeding is a rare event with no pathological significance. There are no studies in the literature demonstrating the frequency of this event in BMRI scans. “

I would rephrase this sentence. Gel bleeding is not virtually ignored but, as far as I know, there are indeed no demonstrations that it can determine any of the known complications.

M&M

How could you justify the biopsy or even the capsulectomy of these no suspicious findings also considering the not negligible risk to damage the implant? please specific better the criteria

EILN: I guess 0.5 cm is a quite low cut-off especially in the axillary/ periprosthetic tissue. Please comment.

Results

Fig. 2 Could you find a sonographic finding correlating to the MRI finding?

Fig.3 What is the curve referring to? Please describe more in detail the figures.

Fig.5 Please report separately the two cases and describe more in detail the figures (MRI sequence, finding, etc.)

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Reviewer #1: No

Reviewer #2: No

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Silicone Induced Granuloma of Breast Implant Capsule (SIGBIC) diagnosis: Breast Magnetic Resonance (BMR) sensitivity to detect silicone bleeding.

PONE-D-20-00357R1

Dear Dr. Fleury,

Dear colleague!

We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements.

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With kind regards,

Pascal A. T. Baltzer, M.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Please do very carefully proofread your article. Being not a native english speaker myself, I understand that the manuscript is not free of small typographic and idiomatic mistakes, but there are some ackward typos (pos instead of post in a figure, some pseudo-english technical terms) I would strongly suggest you to correct in the prior to production.

Reviewers' comments: