DOI: 10.1097/PRS.0000000000003968
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PMID: 28938346
Issn Print: 0032-1052
Publication Date: 2018/01/01
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Excerpt
Plastic and Reconstructive Surgery has acknowledged the speculative nature of this hypothesis by classifying the level of evidence as “risk” rather than accepting it as a proven link. However, within Australia and increasingly elsewhere, the work is being promoted as “proof” of a link between an infective cause and the development of ALCL.3
It is worth making the following observations concerning the published data: Of the 26 ALCL cases described with bacterial contamination, only 10 are cosmetic patients. The remainder have breast malignancy, and may be more susceptible to development of lymphoma or Ralstonia species, particularly if they had undergone chemotherapy.
Of the 10 cosmetic cases, two cannot be cohesive gel technology, given their age. Of the remaining eight cases, six are known to be textured. The hypothesis is therefore based on six cases of modern implants worldwide. More important is the lack of adequate control groups by which these six cases may be judged. Only three of the 26 cases had a control specimen taken from the contralateral breast.
Of the 62 patients with high-grade capsular contracture taken as nonmatched controls, it is not clear whether these patients had cohesive gel and/or textured implants. Nor is it indicated whether or not they were matched as reconstructive or cosmetic cases.
In addition, and perhaps most importantly, there are no control specimens from individuals that have neither capsule nor ALCL. It cannot be determined therefore whether Ralstonia species exists as a normal body commensal in some or all patients with breast implants. Although accepting that this might be the most difficult control information to collect, it is the most important, as should it prove to be the case, efforts to find a cause for ALCL might be best directed elsewhere. It is unfortunate that this proposed link between infection and ALCL is now becoming enshrined as fact and quoted as such in subsequent publications.
The authors should be congratulated for producing a unified hypothesis for the development of this rare condition. However, it risks an alarmist view, which is indeed adopted by Dr. Adams, who has written, “the finding of high levels of a single bacterial species … in all but one specimen is irrefutable evidence of the significant role of bacteria in the process.”4 Another British plastic surgeon has recently been reported in the press: “Textured implants should be banned. We should return to using smooth ones which were safe.”5 Clearly, without the appropriate controls, neither statement can be justified from the published evidence.
