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• W4386316204 abstract "Dr Deva, in his recent commentary,1 writes, “It is important that the role of the practitioner, his/her clinical skill and training be studied in all reported adverse events related to breast implants. To ignore this would be to perpetuate the myth that the clinician remains blameless and to falsely ascribe risk solely to the device or patient.” This comment merits our close consideration. Such a recommendation would place a huge burden on any reporting agency and serve as a disincentive for reporting adverse events. Blaming implanting surgeons also has serious medicolegal implications. Is it justified? Deva's opening quote that “to err is human” implies that breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) might be caused by an error in operative technique. This quote and a recommendation to investigate practitioners with BIA-ALCL cases are remarkable because no technical deficiency has been linked to BIA-ALCL.2–4 This is an important distinction because industry and its surrogates have promoted the narrative that it is a technical shortcoming—failure to observe proper sterility on the part of plastic surgeons—that causes BIA-ALCL, not a faulty device.2,4 Allergan (an AbbVie Company, North Chicago, Ill) firmly supported its textured implants as safe,5,6 right up until the day this manufacturer was asked by the US Food and Drug Administration (FDA) to remove its Biocell implants from the US market.7 Surprisingly, Deva1 does not mention or reference the 14-point plan (which does not include abandoning textured devices) that he coauthored,8 despite his outspoken efforts to promote and defend this plan in the past,9 including a lengthy rebuttal8 to my 2017 editorial, which questioned the scientific validity of the 14 points.10 Also conspicuous is the absence of a reference to the widely cited study (or more precisely survey) that Dr Deva coauthored with his frequent collaborator, Dr Adams, and others in 2017.11 This study of 42,000 Allergan Biocell implants concluded that adoption of the 14-point plan could eliminate the risk of BIA-ALCL. This publication contained falsified data and ethical lapses that undermined its misleading and harmful message that the device was not at fault but rather the implanting plastic surgeon who did not follow the 14 points.2,12 This publication was used by the manufacturer and its surrogates at the February 2019 French regulatory hearing and the March 2019 FDA Hearing to defend the continued availability of Allergan Biocell implants.2 At the 2018 annual meeting of the American Society for Aesthetic Plastic Surgery, Dr Deva13 memorably presented a slide of Miss Piggy, the Muppets character, performing breast surgery. Deva also showed a slide depicting surgeons operating in surgical body suits (“space suits”) for enhanced sterility. Obviously, his point was that surgeons using inadequate sterility is a problem, supporting the corporate narrative. In 2019, Deva14 lamented a “never-ending cycle” of breast implant crises. Critics of textured implants, he suggested, are motivated by emotion and fear, not science. He surmised that those of us who are not informed by reason cannot be persuaded by reason9 and that focusing on texture, and targeting a specific implant, is simplistic and wrong.9,14 He cited the interplay of the patient, implant, and other environmental factors. He suggested that a ban would limit choice and not serve the patient well. Deva14 cautioned that the 2019 French regulatory action to ban macrotextured implants caused a “crashing halt as we head down a path that leads to increasing uncertainty and fear.” Rather than ban the product, Deva14 preferred to continue publishing articles on this topic and presenting at meetings. Shortly after the publication of Deva's editorial, my rebuttal was published, calling for action to abandon textured breast implants.6 The month after its publication, on July 24, 2019, the FDA changed course and banned Biocell implants.7 By this time, Deva said he now “fully supported” a proposal to ban macrotextured devices in Australia and “to sit around and wait for another 50% rise [in BIA-ALCL cases] in 2020 is not fair to patients and is not safe.”15 Deva affirmed, “Rightfully, the regulator is starting to take action.”16 This personal evolution fits with the 3 stages of truth, as reported by Clemens4,17 (quoting Schopenhauer)18—first it is ridiculed; second, it is violently opposed; and third, it is accepted as being self-evident. In his commentary, Deva1 references an article by Venkataram et al.19 This study contained numerous limitations undermining its conclusion in support of Betadine as a method to reduce capsular contracture, including lack of a control group for comparison.20 Betadine is nonsterile, meant for topical use only, and not authorized for application in an open breast wound. It is also cytotoxic. Its use should be abandoned.20 Scientifically, if a surgeon adheres to an ordinary sterile operating technique, there is no opportunity for external contamination.20 The implant comes out of the box sterile, is handled by sterile gloves, and is inserted into a nonsterile pocket that is colonized by harmless commensal bacteria. Clemens,21 at the 2019 FDA Hearing, clarified that there is no evidence of any effect of the 14 points on BIA-ALCL risk. In view of the (possibly protective) commensal organisms that reside in the breast, it is not clear that these bacteria should be eliminated. In fact, to do so might do more harm than good.20 Deva blames BIA-ALCL on bacteria introduced at the time of surgery, infecting the implant.16 Deva's laboratory implicated the gram-negative bacterium, Ralstonia pickettii, in the etiology of BIA-ALCL.22 This finding has not been reproduced.3,23 This microbe is likely a contaminant.23 Hu et al22 reported higher bacterial counts on the side affected by BIA-ALCL compared with the contralateral control breast. However, the sample size was only 3, too small to make any reliable conclusions. The overall bacterial counts for BIA-ALCL were slightly lower for BIA-ALCL than for nontumor capsule specimens. A sophisticated microbiological study using 16S rRNA microbiome sequencing revealed no significant difference in the relative abundance of gram-negative bacteria between BIA-ALCL and control specimens.24 The microbiome seems to be patient specific, not disease specific. No specific microbe has been reliably linked to BIA-ALCL. There is still no known case of a bacterial endotoxin causing a T-cell lymphoma.2 Today, biofilm, Ralstonia, and bacterial contamination have been largely abandoned as plausible etiologies for BIA-ALCL.2–4,23 Deva1,25 references a recent study conducted in his laboratory.26 The authors studied the reaction of BIA-ALCL cells in vitro, exposing them to various stimulation assays, finding that they responded to gram-negative bacterial lipopolysaccharide. Breast implant shells did not produce a similar proliferative response of BIA-ALCL cells. With regard to etiology, the question is what triggers normal cells to become T-cell lymphomas, not how cells that have already become cancerous react to stimuli. This in vitro study could not simulate chronic inflammation and an immunocompromised periprosthetic zone. The investigators conclude that “the breast implant does not produce a proliferative response of BIA-ALCL cells, indicating the breast implant does not act as a pro-inflammatory stimulant.”26 This statement is at odds with the observation by other investigators that a textured implant does provoke an inflammatory response.23 Indeed, BIA-ALCL is not known to occur without this stimulus.23 It is overstepping to claim that “BIA-ALCL is caused by chronic inflammation by a gram-negative microbiome.”19 Mempin et al26 conclude that the data “support the clinical practice of minimizing the bacterial load on breast implants.” Textured breast implants carry much greater bacterial loads than smooth implants.27 Advocates of an infectious etiology for BIA-ALCL, if they were unconflicted by industry, might be expected to recommend against textured devices on this basis alone. However, the study by Mempin et al,26 like all corporate-sponsored studies, does not conclude that smooth implants should be used exclusively. Rather, it concludes that doctors should minimize the bacterial load. How is this reduction to be accomplished? Once again, there is no reference to the 14-point plan that is supposed to reduce the bacterial load.8,9 At one time, Deva9 was so committed to this plan that he asked plastic surgeons to pledge that they would adhere to it. Today, almost all investigators believe that BIA-ALCL is triggered by the textured surface, particulates, chronic inflammation, and an immunocompromised zone around the implant, with some patients being more genetically susceptible.23,28–30 The Scientific Committee on Health, Emerging and Environmental Risks concluded that a causal relationship has now been established between textured devices and BIA-ALCL.30 With some irony, Deva25 laments those investigators with an “agenda.” He concedes that he has been accused of being “bacteriocentric.”25 Such a perspective is understandable for an investigator who runs a microbiological laboratory with industry funding14 and invested in a bacterial etiology for BIA-ALCL. Although Deva14 contends that his research is “free from any commercial strings,” he has disclosed financial conflicts with the major implant manufacturers. Caution is needed when finding fault with other licensed practitioners who perform breast augmentation. It is interesting to consider whether a study (if it were possible) examining board certification as a factor in BIA-ALCL etiology in the United States might find that board-certified surgeons have a higher risk than non–board-certified surgeons simply because they are inserting more textured implants and providing close follow-up care. Noncertified surgeons implanting less expensive smooth implants, particularly in the United States where smooth implants have been used more commonly, would not be expected to encounter this complication. Plastic surgeons must be careful not to use BIA-ALCL as a weapon4 against their competitors or add regulations that are irrelevant to the risk of this disease. Deva,25 who serves as an advisor to government regulators, believes that breast augmentations should be performed in “proper hospitals” and not clinics or “back rooms.”25 Mandating that breast implant surgery be performed only in hospitals would make the procedure more expensive for patients, create a burden for hospital resources, and expose patients to the downsides of hospitalization, including greater bureaucracy, exposure to nosocomial infections, more difficult scheduling, less control over personnel including nursing and anesthesia, and inconvenience. Outpatient surgery in properly accredited outpatient facilities has proven its place in the delivery of safe medical care.31 To insist on hospital care would also eliminate competitors who do not have hospital privileges, which is anticompetitive. Deva and his colleagues have reported a higher frequency of BIA-ALCL cases for surgeons who are not certified as specialist surgeons.32 Noncertified surgeons reportedly accounted for a disproportionate share of cosmetic BIA-ALCL cases according to implant sales data in Australia. This is an important finding and one that merits scrutiny. All breast reconstructions and postbariatric surgery augmentation/mastopexy cases (29% of total cases), which were not included in the analysis, were performed by certified surgeons. Therefore, using an implant sales figure (eg, 15%) as a proxy for the number of cosmetic cases performed by noncertified surgeons may be too low. The statistical method to compare the groups is unclear. Percentages are provided rather than numerical data for the implant types. The confidence intervals are very wide and P values are extremely small for this small patient population (n = 67). The authors do not offer an explanation in terms of precisely what these doctors are doing differently that increases the BIA-ALCL risk. The authors' recommendations include shared decision making (a general practitioner must agree with the surgery), 2 consultations, and a 7-day cooling-off period after the second consultation before surgery can be scheduled.32 Unfortunately, on July 1, 2023, these recommendations became regulations in Australia. Other provisions include mandatory psychological screening evaluations for body dysmorphic disorder, plus practitioner performance reviews and measurement of outcomes.33 It is not clear who does the reviewing. It is also unclear how the data support these changes to improve safety as opposed to creating new obstacles for patients and surgeons. Such patronizing regulations (eg, “A medical practitioner must decline to perform the surgery if they believe that it is not in the best interests of the patient”) imply that plastic surgeons cannot be trusted to recommend surgery, that patients' decisions are impulsive and possibly irrational, that cosmetic surgery patients require psychological evaluation, and that the government is needed to protect patients and surgeons from themselves. None of these measures has any relevance to BIA-ALCL risk. Attention is being diverted from the true culprit—a textured breast implant. Dr Deva1,25 believes that BIA-ALCL “clusters” suggest that 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.”34 Most surgeons believe a local collection of BIA-ALCL cases does not signify operator deficiency but rather an honest, commendable, and meticulous follow-up of a group of high-risk patients implanted with Biocell devices.2,4 Countries with specific informed consents, mandatory reporting, and national implant registries report a greater number of cases than countries that do not have these safeguards.35 Clustering is not caused by bacteria or surgeons using poor technique; such misinformation is perpetuated by industry proxies.2,4 There is no need to examine Dr Cordeiro's credentials, which of course are impeccable.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.2–4 Deva's1,25 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 disease30 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. True, some patients may be genetically predisposed to developing BIA-ALCL,3,23 but in all cases, a trigger is needed—a textured device.36 No textured device means no BIA-ALCL. There is no justification for a “thorough and independent evaluation of that clinician, his/her training and credentialing and operative technique” in cases of BIA-ALCL,1 even if that were feasible. There is no need for a witch hunt. This is not to say that there is no blame. Some humility is in order. Plastic surgery, as a specialty, did not respond correctly to the textured implant crisis.37 As soon as the link to textured implants was made, by Brody et al38 in their landmark 2015 publication, plastic surgeons should have abandoned this harmful device. Instead, highly compensated industry surrogates promoted a false message—that the technique (ie, the surgeon) was the problem, not the device.2,37 Plastic surgeons unanimously defended textured devices at the 2019 FDA Hearing.37 Before agreeing with the ban, Deva9,39 considered proposals to stop using these devices rushed, uninformed by reason, and “strident.” Fortunately, the FDA eventually made the correct call in banning macrotextured devices,7 despite the efforts of conflicted plastic surgeons to keep them available.37 Plastic surgeons missed an opportunity to lead the way.37 This crisis is a case study in the harm to our specialty created by corporate subsidies to plastic surgeons and our societies, particularly from Allergan.2,37,40 The silver lining is that perhaps this unfortunate experience can motivate us to correct our course, relieve our specialty from corporate control,37,40 and allow plastic surgeons to truly function in our patients' best interests." @default.
• W4386316204 created "2023-09-01" @default.
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• W4386316204 date "2023-08-31" @default.
• W4386316204 modified "2023-09-29" @default.
• W4386316204 title "Breast Implant–Associated Anaplastic Large-Cell Lymphoma" @default.
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