Breast Implant–Associated Anaplastic Large-Cell Lymphoma

Swanson, Eric

doi:10.1097/sap.0000000000003684

Cited by 2 publications

(3 citation statements)

References 38 publications

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“…3 The authors endorse the 14-point plan to reduce CC risk, despite the lack of scientific foundation for these points. 8 Notably, Deva, the co-author of these points, 28 no longer promotes these 14 points in his publications and presentations. 29,30 Similar to the other 2 recent reviews, 1,2 no references were made to numerous publications opposing a role for antimicrobial irrigation, [11][12][13][14][15][19][20][21][22][23][24] including a meta-analysis.…”

Section: Endorsing Antimicrobial Irrigation Despite Contradictory Evi...mentioning

confidence: 99%

“…15 A textured surface is not advantageous in a subpectoral pocket, 26 and textured implants have been largely abandoned in the United States because of the risk of BIA-ALCL. 8 Another theory holds that a periareolar incision is at greater risk of CC because of its proximity to the nipple ducts. 2 However, a review of access incisions and CC risk is not supportive.…”

Section: Evidence Challenging the Efficacy Of Antimicrobial Irrigationmentioning

confidence: 99%

“…The scientific basis for the 14 points has always been questionable, 7 and this protocol has been largely discredited. 8…”

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confidence: 99%

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Breast Implant Pocket Antimicrobial Irrigation and the Importance of Reporting Contradictory Evidence

Swanson

2024

Ann Plast Surg

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T wo recent Italian studies review the literature on the treatment of capsular contracture (CC) of the breast. 1,2 A third study, from Australia, evaluates data from the Australian Breast Device Registry. 3 All 3 studies endorse irrigation of breast implant pockets with antimicrobial solutions, favoring Betadine. Remarkably, none of the studies discuss or reference contradictory evidence. LIMITATIONS OF PUBLICATIONS SUPPORTING ANTIMICROBIAL IRRIGATIONFederica et al 1 identified 413 publications, selecting 15 studies for inclusion in their review. These reviewers reported that a triple antibiotic solution composed of 50,000 U Bacitracin, Ancef 1 g, and Gentamicin 80 mg reduced the CC rate 4 to 5 times. This is an important conclusion and one that merits close consideration. This figure was taken from an uncontrolled 2006 study by Adams et al, 4 which compared their reported CC rate of 1.8% using triple antibiotic irrigation in breast augmentation patients with external manufacturer core data. The sample size was 172 patients and the mean follow-up time was 14 months. Manufacturer core studies report much greater rates of CC (ie, 8%-19%), 5 likely because of longer, more rigorous follow-up and larger sample sizes.These authors next reference another publication by the same lead author. 6 This 2017 study reported a CC rate of 2.2%, again much lower than figures reported in manufacturer core studies. 5 This 2017 study claimed that following 14 points including antibiotic irrigation could not only greatly reduce the CC risk but also eliminate the risk of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). However, this publication was not based on reliable clinical data. 7 It was actually an email survey by SurveyMonkey, although that fact was not disclosed. There was no description regarding how patients were contacted to determine whether CC or BIA-ALCL had developed.There were other problems with the data. 7 Adams et al 6 reported that 6 surgeons adhered to all 14 points and the other 2 contributing surgeons followed 13 of the 14 points. However, the original survey data revealed that the authors routinely omitted many of the 14 points, especially when performing breast reconstruction (mean, 4.7 points). The follow-up time was implausible. Swedish contributor Hedén reported a 14-year mean follow-up time in 16,000 patients. 6 The article was submitted for publication only 3 years after publication of the 14 points. 7 Breast augmentation patients are not known to keep long-term follow-up appointments. The scientific basis for the 14 points has always been questionable, 7 and this protocol has been largely discredited. 8

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Section: Endorsing Antimicrobial Irrigation Despite Contradictory Evi...mentioning

confidence: 99%

Section: Evidence Challenging the Efficacy Of Antimicrobial Irrigationmentioning

confidence: 99%

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Breast Implant Pocket Antimicrobial Irrigation and the Importance of Reporting Contradictory Evidence

Swanson

2024

Ann Plast Surg

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The Fallacy of a Bacterial Etiology for Capsular Contracture and BIA-ALCL and Assigning Blame to Noncertified Surgeons

Swanson

2024

Ann Plast Surg

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R ecent commentaries consistently implicate bacteria in many complications of breast augmentation, including capsular contracture, breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), and systemic symptoms associated with breast implants, 1-4 also known as breast implant illness. By contrast, numerous publications challenging these views are conspicuously absent from these commentaries and references. 5 Scientific integrity demands that opposing views be accepted or rejected, but not simply ignored. 5 Plastic surgeons deserve to be informed of both sides of the debate. Examples of opposing evidence, mostly published within the last 7 years, are summarized in Table 1.Not only are articles with opposing evidence not referenced, but also a highly cited publication, 15 supporting a bacterial etiology for capsular contracture and BIA-ALCL, remains unreferenced. [1][2][3] This article was used to defend the continued availability of macrotextured implants at the 2019 US Food and Drug Administration hearing. 16 It was not really a prospective cohort study, but rather a retrospective 8-question survey, emailed by SurveyMonkey to the authors, although this fact was not disclosed. 16 A dishonest reporting of the findings undermined the study conclusions. 16 The authors have not issued a correction. Consequently, other investigators may be unaware of these problems. Researchers in Egypt recently published a meta-analysis, including 42,000 macrotextured implants with no BIA-ALCL, which they believed to represent a prospective cohort with an (implausible) 11.7-year mean follow-up, leading to their erroneous conclusion that the BIA-ALCL risk is similar for smooth and textured devices. 30 A false narrative promoted by industry surrogates continues to find fault with the surgeon as opposed to the device. 14 Before recommending treatments that target bacteria, the identity of the responsible microbe is needed. 31 Using specialized cultures, polymerase chain reactions, and scanning electron microscopy, Poppler et al 7 found no correlation between biofilm formation and capsular contracture. Only 1 of 26 patients even demonstrated evidence of a microbial biofilm. The authors cautioned that there was strong evidence from other studies that antimicrobial therapy induces biofilm formation to confer resistance. 7 In other words, antibiotic irrigation may be counterproductive.Another recent study using next-generation sequencing, an evolution of polymerase chain reaction technology, reported microbial DNA in only 42% of capsular contracture specimens and 120 unique bacterial species. 32 Staphylococcus epidermidis was isolated in only 11% of the positive specimens. No control group was studied. Therefore, it is unknown whether these findings were affected by contamination during specimen handling. 33 In fact, no specific microbiome or organism has been linked to capsular contracture. 31 Bacterial profiles appear to be patient-specific rather than disease-specific. 11 Koch's postulates 34 have not been satisfied for an infe...

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Breast Implant–Associated Anaplastic Large-Cell Lymphoma

Cited by 2 publications

References 38 publications

Breast Implant Pocket Antimicrobial Irrigation and the Importance of Reporting Contradictory Evidence

Breast Implant Pocket Antimicrobial Irrigation and the Importance of Reporting Contradictory Evidence

The Fallacy of a Bacterial Etiology for Capsular Contracture and BIA-ALCL and Assigning Blame to Noncertified Surgeons

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