Commentary on: BIA-ALCL Epidemiology in an Aesthetic Breast Surgery Cohort of 1501 Patients

Deva, Anand K.

doi:10.1093/asj/sjad199

Cited by 5 publications

(4 citation statements)

References 17 publications

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“…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. 19 A review by Horsnell et al 18 was referenced in support of pocket antimicrobial irrigation.…”

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

confidence: 91%

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: 91%

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

Swanson

2024

Ann Plast Surg

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“…Dr Deva 1,25 believes that BIA-ALCL "clusters" suggest the surgeons involved in these clusters are part of the problem, ostensibly because they are not adhering to strict enough methods to avert bacterial contamination. Jewell, a coauthor of the discredited 2017 article, 11 suggested in a letter to the editor that a cluster in New York City was likely a result of "surgical technique on the part of Dr. Cordeiro or poor institutional hygiene at Memorial Sloan Kettering Cancer Center, or ineffectual breast pocket irrigation with bacitracin."…”

mentioning

confidence: 99%

“…2,4 Seeking to shame plastic surgeons who report this complication is to be condemned, 3 especially in view of the lack of a known operator component. [2][3][4] Deva's 1,25 graphic showing the device, the patient, and the doctor should be modified by removing the doctor and also the patient, and simply assigning the "blame" on the device. The causal relationship between the device and the disease 30 is the basis for the actions of regulatory bodies all over the globe that have found fault where it lies, squarely with the implant and not with the doctor or patient.…”

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confidence: 99%

Breast Implant–Associated Anaplastic Large-Cell Lymphoma

Swanson

2023

Ann Plast Surg

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“…To suggest that surgeons are to blame for suboptimal sterility leading to BIA-ALCL, Deva presented a slide depicting the operating plastic surgeon as Miss Piggy, the Muppets character, at a 2018 meeting. 19 The 2017 article includes a suggestion that BIA-ALCL is a lymphoproliferative disorder and that the World Health Organization was mistaken in classifying it as a malignancy. 1 The lead author labels it "Brody's disease" instead.…”

mentioning

confidence: 99%

Concerns Regarding Dishonesty in Reporting a Large Study of Patients Treated With Allergan Biocell Breast Implants

Swanson

2022

Ann Plast Surg

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I n 2017, Adams et al 1 published a study reporting no cases of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) among 8 plastic surgeons implanting a total of 42,035 Allergan (now AbbVie Corp, Lake Bluff, IL) Biocell implants. This open-access publication quickly became one of the most viewed studies in the plastic surgery literature. It was featured as a cover article and was the subject of a journal club discussion and podcast. This article is ranked at the 98th percentile among all articles of a similar age. It has received 5372 full text views to date and has been cited in 129 publications. 2 In February 2019, Dr Jason Hammer, executive medical director of Abbvie, testified before the French health regulatory agency that biofilm was the leading theory for the development of BIA-ALCL, and this complication could be prevented by following the 14-point plan. 3 He cited the 2017 "international multicenter study" of 42,000 Biocell implants "followed for over 11 years."The following month, at the 2019 Hearing of the Food and Drug Administration (FDA), the same publication 1 was cited to support the continued use of macrotextured implants. 4 Adams, the lead author, testified that adoption of the 14 points could eliminate the risk of BIA-ALCL. Another plastic surgeon, and spokesperson for Allergan, also referenced this 2017 study 1 in her testimony and claimed a zero rate of BIA-ALCL when the 14 steps are followed. A handout distributed at the meeting and still available at the FDA Web site includes this claim and reference. 5 Six of the 8 authors of the 2017 study 1 disclosed that they were Allergan consultants, 1 including Adams, who denied financial conflicts at the FDA hearing, 4 despite a publication disclosing his conflicts with Allergan and Sientra. 6

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Commentary on: BIA-ALCL Epidemiology in an Aesthetic Breast Surgery Cohort of 1501 Patients

Cited by 5 publications

References 17 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

Breast Implant–Associated Anaplastic Large-Cell Lymphoma

Concerns Regarding Dishonesty in Reporting a Large Study of Patients Treated With Allergan Biocell Breast Implants

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