Annals of Plastic Surgery | 2019
A Rebuttal of Antibiotic Irrigation as a Method to Reduce Risk of Capsular Contracture and Breast Implant-Associated Anaplastic Large-Cell Lymphoma
Abstract
I n a recently published article, Culbertson et al make the case for antibiotic irrigation at the time of breast augmentation. The abstract states that this method has “been proven to reduce capsular contracture by 10 over the past 20 years.” At the 2019 U.S. Food and Drug Administration (FDA) Hearing, Dr. Adams, a coauthor, testified that the 14-point plan, which includes antibiotic irrigation, has reduced the risk of capsular contracture from 50% to less than 1% over the last 30 years. However, manufacturer core studies do not support either statement. There has been no significant downward trend in capsular contracture rates (Fig. 1). The authors state that the 14-point plan can also minimize the risk of Breast Implant-Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL). At the 2019 FDA Hearing, Dr. Adams testified that this plan could even eliminate BIA-ALCL risk. A 2017 study by Adams et al is offered to support this claim. The findings of this study have been challenged. Presentations and publications by the authors during the “prospective” study period show that in fact the 8 contributors did not all follow at least 13 points as reported. A mean 11.7-year follow-up was claimed, although Dr. Adams shortened this period to 9 years in his FDA presentation. Regardless, such a long mean follow-up period is simply not credible for this group of patients. This point is well known to any investigator who has studied breast augmentation patients, who are not known for their willingness to return for long-term follow-up appointments, particularly if they have no complaints. In fact, an 11.7-year mean follow-up is not even mathematically possible for patients followed for 1 to 14 years. Moreover, the 14-point plan was published in 2013. There is no mention as to how the reported 2.2% capsular contracture rate was determined. Six of the 8 authors of this study were consultants to Allergan (Allergan plc, Dublin, Ireland). A retrospective study design allows selection bias in that only surgeons who were not known to have a case of BIA-ALCL were selected for inclusion. These important factual issues undermine the conclusion. Importantly, Culbertson et al deny any “potential” or “related” conflict of interest. Drs. Adams and Deva, both coauthors of the study, have previously acknowledged conflicts with Allergan and other implant companies. The authors may believe that money received from breast implant manufacturers does not constitute a relevant conflict of interest. That determination should be made by the reader. A representative for Allergan at the FDA hearing also referenced the 2017 study by Adams et al, claiming that following these 14 points eliminates the BIA-ALCL risk. Allergan even paid for the graphic demonstrating the 14 points. Blaming a faulty technique rather than acknowledging a problem with textured implants fits with the corporate narrative. Allergan has insisted on the safety of all of its implants as posing “no immediate risk.” Nevertheless, on July 24, 2019, Allergan issued a global recall of Biocell implants and tissue expanders in response to a request from the FDA. In his testimony to the FDA, Dr. Clemens emphasized the lack of scientific support for any of the 14 points. It is remarkable that these points do not include “avoid textured implants,” in viewof thewell-known fact, conceded by these authors, that implant surface texturing is exclusively linked to BIA-ALCL. Dr. Deva has not promoted the 14-point plan in his recent panel presentations. However, the 14 points still appear in journal publications. A “Best Practices” advisory for preventing BIA-ALCL, with the endorsement of the major plastic surgery professional societies, continues to recommend these steps and others, such as “limit unnecessary personnel in the operating room,”with nomention of abandoning textured devices. In support of an infectious etiology for BIA-ALCL, the authors reference a commonly cited study by Hu et al. The findings of this study are often misquoted. This study found 4.7 10 bacteria/mg in the BIA-ALCL samples (n = 21) versus 4.9 10 bacteria/mg in the nontumor capsule specimens from patients with capsular contracture (n = 62). The nontumor samples from patients with capsular contracture but without BIA-ALCL actually contained more bacteria than the BIA-ALCL samples, although probably not significantly. This study was limited by a lack of control specimens. A comparison of bacterial counts in 3 women, comparing the breast capsule affected by BIA-ALCL to the normal breast capsule, was too small to be meaningful.