Then one day there really was a wolf but when the boy shouted, they didn’t believe him.…
If any editorial requires a discussion, this one certainly does. We find the distortion of the data in this Editorial to be truly disappointing, and we are happy to detail this for the readership.
Swanson has approached the topic with a preformed position and used suspect interpretation of self-selected data to arrive at an erroneous conclusion. In fact, at times we were not exactly sure what the thesis of the Editorial was supposed to be: Antibiotic irrigation? Textured implants? Povidone-iodine? The 14-point plan? We will discuss and prove the following:
- The best available data fully support the use of proper antimicrobial breast pocket irrigation, and the small amount of data that do not favor breast pocket irrigation are significantly flawed.
- The conclusions are not evidence-based, and are clinically detrimental.
Swanson statement: “An implant coming out of the container is sterile. It cannot be made any more sterile by bathing it in antibiotics.”
Fact check: The author does not seem to understand the concept of bacterial load and its importance in reducing device-associated infection.1 A sterile implant in the package does not remain sterile in any breast procedure or orthopedic procedure. Ultimately, the outcome is dependent on the quantitative bacterial load at the time of closure and then continuing over time. The notion that one is completely “sterilizing the environment” in any surgical procedure is faulty—the objective is reducing the bacterial load to a level that is manageable by the body’s own defense system.
Swanson cites 33 separate references in the editorial; however, he chooses to cite and interpret them based on what appears to be a misguided bias. For example, he cites the original University of Texas Southwestern clinical study2 that further supports the clinical use of proven antibiotic irrigations [Betadine triple (Purdue Frederick, Stamford, Conn.) and non-Betadine triple antibiotic]. Swanson states that the data are minimized because of the lack of a control group, yet in his next paragraph claims a study using the Sientra clinical trial as acceptable data; however, this was a premarket approval study that also had no control group. We find this a curious paradox indeed. Have the rules changed from one paragraph to the next?
This further underscores the primary flaw in the Editorial, which is that one cannot simply interpret data with one’s own set of rules. Including flawed studies that might prove a desired bias is not acceptable. Specifically, Swanson relies almost exclusively on two studies: the Sientra premarket approval clinical trial study3 and a meta-analysis that includes the same premarket approval study.4
Fact check: The Sientra premarket approval study (when used for assessment of antimicrobial breast pocket irrigation) has no defined control group, and this flaw caused it to be excluded from two recent, well-performed meta-analyses on the same subject.5,6 The bigger issue with this clinical trial study is that it was performed as a premarket approval study for U.S. Food and Drug Administration approval of Sientra implants. None of the variables necessary to assess infection or capsular contracture at a detailed level were properly collected in the original study design, nor were important variables that we know directly affect capsular contracture controlled. This is a critical distinction. Typical of all premarket approval studies, the Sientra premarket approval study attempted to look at the safety and efficacy of the implant over time (and did a very good job of showing this); however, the data collected are unable to specifically answer questions about more granular aspects of the surgery. Specific limitations with regard to analysis of breast-pocket irrigation in the premarket approval study include no detailed collections of specific types of breast pocket irrigation, including detailed concentrations, specific agents, processes for irrigating, and volumes of irrigation.
Techniques were also not controlled across the study, including specific dissection techniques, types of pockets, insertion techniques, and specific closure techniques. All of these nine variables directly affect capsular contracture; however, this premarket approval study was never designed to draw conclusions on details of capsular contracture or breast pocket irrigation. We mention this not to criticize the Sientra premarket approval study, but to illustrate its limitations. This problem with data mining premarket approval studies is well known and not limited to this particular study, and it has been cited before.7 It is also curious that the same lead author published a study in 20108 in which Betadine antimicrobial irrigation was part of the operative protocol and the authors partially attributed the low capsular contracture rate (1.2 percent) to the use of antimicrobial irrigation—yet 3 years later in the Sientra study, the same author states Betadine now increases contracture.
In addition, the meta-analysis referenced 11 times in this article inaccurately uses the same data-mined Sientra premarket approval study (detailed above) in its analysis. The obvious problem including the meta-analysis with close to 2500 patients skews the meta-analysis by significantly weighting the study versus other appropriately designed studies from single investigators with fewer numbers of patients. Not surprisingly, the conclusion of this meta-analysis is the exact same as that of the data-mined premarket approval study. Of note, the meta-analysis used seven studies, and the other six all favored antimicrobial breast pocket irrigation. Interestingly, this is a classic Simpson’s paradox where the outcome of a meta-analysis is opposite of what the majority of the included studies conclude. It is surprising that this meta-analysis was accepted for publication in a tertiary plastic surgery journal, likely after being rejected from top-tier peer-review for reasons stated above.
Swanson statement: “Meta-analyses are valued because sample size is increased, increasing power, and reducing statistical error.…”
Fact check: So lets look at the available meta-analyses on this topic. The author attempts to discredit a well-performed meta-analysis Yalanis et al. published in this Journal,6 but it is interesting that he selectively does not disclose the study concluded that povidone-iodine breast pocket irrigation reduces grade 3 to 4 capsular contracture.
Since the author “likes” meta-analyses, we were surprised that he did not include what is the best meta-analysis on the subject. Perhaps that is because the best data do not support his bias. This study, from Johns Hopkins, is a properly performed meta-analysis and corrected the flaws of the aforementioned meta-analysis by Drinane et al. The study concluded the “the meta-analyses support the use of antibiotic irrigation of the breast pocket.” The data showed significantly lower capsular contracture and infection in the breast pocket irrigation group (Betadine, Betadine triple, non-Betadine triple, and other antibiotic combinations).
Next, the author misleads the reader in discussing a 2017 review by Horsnell et al.9 He states: “The other two studies reported no benefit of antibiotic irrigation.” 3,10
Fact check: This is simply not true. Pfeiffer et al. concluded in their retrospective review10 that “data support the use of topical antibiotics in cosmetic breast surgery.” The study had two groups, one with saline and one with Keflin (Eli Lilly & Co., Indianapolis, Ind.) irrigation. The antibiotic-irrigation group had significant reduction of infections and seroma, and a nonsignificant reduction in capsular contracture. Swanson goes on to say that Horsnell et al.9 “concluded that the quality of evidence supporting antibiotic irrigation was poor.”
Fact check: The conclusion actually states: “Where available the literature tends to support the use of antibiotic and povidone-iodine irrigation, the use of insertion funnels and nipple shield and the avoidance of drains….”
Swanson statement: “In summary, antibiotic irrigation is unsupported by three systematic reviews.…”4,9,11
Fact check: We decided to fact check this claim as well. We found similar academic indiscretions. The issues with the meta-analysis by Drinane et al. and the misrepresentation of the review by Horsnell et al. have been detailed above, but we were unfamiliar with the final reference of Samargandi et al., and our investigation found the following:
- The reference is misleading as listed. This is not a publication in Plastic and Reconstructive Surgery. In fact, this is not even a peer-reviewed publication anywhere. It was an abstract accepted at the 2015 American Society of Plastic Surgeons meeting, and the abstract was listed in PRS Global Open.
- Swanson claims this study found that antibiotic irrigation was “unsupported”; however, this is the actual conclusion from that abstract: “The current evidence favors the instillation of antibiotic irrigation solution in primary breast augmentation.”
Swanson statement: “Antibiotic irrigation is not innocuous. The inflammation caused by antibiotics is well known among plastic surgeons, who use antibiotics (tetracycline typically) as a sclerosant to seal chronic seromas.”
Fact check: We are not aware of anyone recommending using tetracycline or doxycycline as an irrigant. Antibiotics used in breast pocket irrigation are not used for sclerosant indications; in fact, the concentrations are similar to parenteral doses, and the breast pocket preparations are much more dilute than typical tetracycline or doxycycline seroma preparations.
Swanson statement: “Betadine (10% povidone-iodine) is cytotoxic.… Guidelines published in Annals of Surgery warn that povidone-iodine solution is ineffective in decontaminating wounds and has been shown to inhibit wound healing….”12
Fact check: The cited article from Alexander et al. summarizes the discussion on topical wound irrigation with the following supportive statement: “Topical antibiotics are clearly effective in reducing wound infections and may be as effective as the use of systemic antibiotics.”12 In this article, they do cite the potential cytotoxic effects of povidone-iodine. We and others have addressed this previously.13,14 Even normal saline is cytotoxic to fibroblasts.13,14 Topical antibiotics and povidone-iodine have been shown to decrease wound infection, bacterial load, and adverse outcomes in Level I studies in many surgical specialties.15–23 Our basic science and clinical studies in breast augmentation found Betadine triple combination to provide broad-spectrum coverage and five to 10 times lower capsular contracture compared with a U.S. Food and Drug Administration clinical trial while minimizing the concentration of Betadine.2,13,24,25
Swanson statement: “Moreover, povidone-iodine solution is not sterile.…”
Fact check: The outside of the bottle is not sterile. The inside of the bottle is sterile. There are many Betadine preparations that can be purchased and are sterile. The history of Betadine products used as skin preparation and antiseptic is well documented. There was a manufacturing issue more than 25 years ago that led to contamination of some Betadine preparations, but this was corrected many years ago.
Swanson statement: “Of course, the liberal use of antibiotics stimulates the emergence of resistant organisms in the community.”
Fact check: This is not true for local wound irrigations, as the mechanism for the development of resistance is different from systemic use and is associated with a much lower risk.15,26–28
Swanson statement: “Triple antibiotics add unnecessary cost to the surgery. Allowing the antibiotic solution to soak in the pocket in an effort to improve tissue penetration (30 minutes is recommended for cefazolin) prolongs the surgery time and may cause more tissue toxicity and impair early wound healing.”
Fact check: We are not sure what preparation the author is referring to, as “antibiotic solution” is nonspecific. The cost of a 500-cc dose of Betadine triple is $3.77; the cost of non-Betadine triple antibiotic is $7.88, and the cost of 500 cc of 50% Betadine is $1.70. Consumers routinely pay $6.00 for a Starbucks coffee. We contend the expense is a nonissue.
Furthermore, local antimicrobial breast pocket irrigation is not trying to obtain tissue levels—that is why it is called “local irrigation.” It takes us less than 30 seconds to fully irrigate both breast pockets, and the contact time is estimated to be 18 to 24 hours. As far as wound healing effects—sometimes what we see in a Petri dish needs to be taken in context to what we see in the clinical setting. There has never been an animal or human study for plastic surgery indications that has demonstrated a negative outcome of any wound-healing effect of local irrigation, Betadine or non-Betadine based.2,13–15,25,29
Swanson statement: “Despite the preponderance of evidence against its efficacy, antibiotic irrigation is still considered by some surgeons to be part of the standard of care, and is promoted by our professional societies as a component of ‘best practices.’ Alternatively, plastic surgeons may use sterile saline solution for pocket irrigation. In 2000, the author discontinued using povidone-iodine and used only saline solution thereafter.”
Fact check: The reality is that the use of proper antimicrobial breast pocket irrigation is an evidence-based practice. All of the best 21 studies have supported the use of Betadine/antibiotic breast pocket irrigations. There are far more positive data on this subject than the majority of other plastic surgery practices. We present and summarize the data as follows (all of which are supportive of breast pocket irrigation).
- Three randomized clinical trials and four retrospective comparative studies.10,30–35 All of these support antimicrobial breast pocket irrigation.
- Two meta-analyses.5,6 Both of these support antimicrobial breast pocket irrigation.
- Four clinical case series.2,8,36,37 All of these support antimicrobial breast pocket irrigation.
- Eight basic science studies or extensive re views.9,13,14,24,25,29,38,39 All of these support antimicrobial breast pocket irrigation.
- Nine (seven of which are Level I and II) studies in other surgical specialties supporting the efficacy of antibiotic irrigation.15–23,40 All of these support local antibiotic irrigation in surgical procedures.
There is one study that did not find a benefit to antibiotic irrigation over saline irrigation.41 This study had very small numbers and also abundant methodologic flaws.
The reader should look at the list of 30 studies above and decide whether the author is validated in his statement that “despite the preponderance of evidence against its efficacy.” The actual data confirm that the preponderance of evidence supports the practice of antimicrobial breast pocket irrigation.
Furthermore, the risk-to-benefit and tradeoff analyses also are strongly in favor of antimicrobial breast pocket irrigation, and it easily passes the “family test.” We do not foresee a case where proper use of antimicrobial breast-pocket irrigation would not be indicated and desired. We submit that the “cop out” that “more data are needed” or “further higher level studies are warranted” are, first of all, always true of any topic. On this topic, however, the data are very clear and with virtually no tradeoff.
It is discouraging how many people are shocked by honesty and how few by deceit.
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