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Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants

de Boer, Mintsje, M.D.; Hauptmann, Michael, Ph.D.; de Jong, Daphne, M.D., Ph.D.; van Leeuwen, Flora E., Ph.D.; Rakhorst, Hinne A., M.D., Ph.D.; van der Hulst, René R. W. J., M.D., Ph.D.

Plastic and Reconstructive Surgery: October 2018 - Volume 142 - Issue 4 - p 590e-591e
doi: 10.1097/PRS.0000000000004783
Letters
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Department of Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands

Department of Epidemiology and Biostatistics, Netherlands Cancer Institute, Amsterdam, The Netherlands

Department of Pathology, VU University Medical Centre, Amsterdam, The Netherlands

Department of Epidemiology and Biostatistics, Netherlands Cancer Institute, Amsterdam, The Netherlands

Department of Plastic, Reconstructive, and Hand Surgery, Medisch Spectrum Twente, Enschede, The Netherlands

Department of Plastic, Reconstructive and Hand-Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands

Correspondence to Dr. van der Hulst, Maastricht University Medial Centre, P Debeyelaan 25, 6229 HX Maastricht, The Netherlands, r.vander.hulst@mumc.nl

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Sir:

We read the publication “Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants”1 with great interest. Based on the hypothesis that the implant-related microbial biofilm plays a major role in the pathogenesis of breast implant–associated anaplastic large cell lymphoma (ALCL), the authors suggest that a 14-point plan reduces the bacterial load/contamination associated with macrotextured breast implants and, as a consequence, may lower the risk of breast implant–associated ALCL.2

In their study, 21,650 patients with 42,035 Biocell (Allergan, Inc., Dublin, Ireland) macrotextured breast implants were followed for a median of 11.7 years (range, 1 to 14 years) and 353 patients with 704 polyurethane breast implants were followed for a median of 8.0 years (range, 1 to 20 years). Eight surgeons who followed the 14-point plan reported no cases of breast implant–associated ALCL during the follow-up period of this study,1 which represents an incidence rate of 0 per approximately 256,129 person-years, with an upper one-sided 95 percent confidence limit of approximately 12 per 1 million person-years. Recently, we performed a population-based case-control study on all breast implant–associated ALCL cases diagnosed between 1990 and 2016 in The Netherlands and observed a relative risk of 421.8 which, based on the cumulative absolute risk, corresponds to an incidence rate of 4 per 1 million person-years among women who had received implants of any type following standard procedures.3 The data by Adams et al. are therefore consistent with a substantially increased ALCL risk as observed in our study.

In our population-based series, only 11 of 32 cases (34 percent) were diagnosed with breast implant–associated ALCL within 10 years after first implantation.3 The relatively short follow-up period of the series by Adams et al. may lead to an underestimation of the incidence of breast implant–associated ALCL. Another possible confounding factor may be that a multicenter study of healthy individuals undergoing breast implants for primarily cosmetic reasons may contain incomplete follow-up information, which is essential for assessment of the true incidence of breast implant–associated ALCL.

Although we fully agree that optimizing surgical techniques remains essential to optimize surgical results, the study by Adams et al. falls short of providing sound evidence that the 14-point approach reduces the risk of lymphoma in women with breast implants. Prospective clinical trials that are adequately powered for rigorous statistical analyses are needed to answer the important questions regarding lymphoma risk. Furthermore, a deeper exploration of the role of inflammation on lymphomagenesis is also warranted to fully understand the relationship between breast implants and lymphoma in the context of breast implant–associated ALCL.

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DISCLOSURE

None of the authors has a financial interest in any of the products or devices mentioned in this communication. No funding was obtained.

Mintsje de Boer, M.D.Department of Plastic, Reconstructive, and Hand SurgeryMaastricht University Medical CentreMaastricht, The Netherlands

Michael Hauptmann, Ph.D.Department of Epidemiology and BiostatisticsNetherlands Cancer InstituteAmsterdam, The Netherlands

Daphne de Jong, M.D., Ph.D.Department of PathologyVU University Medical CentreAmsterdam, The Netherlands

Flora E. van Leeuwen, Ph.D.Department of Epidemiology and BiostatisticsNetherlands Cancer InstituteAmsterdam, The Netherlands

Hinne A. Rakhorst, M.D., Ph.D.Department of Plastic, Reconstructive, and Hand SurgeryMedisch Spectrum TwenteEnschede, The Netherlands

René R. W. J. van der Hulst, M.D., Ph.D.Department of Plastic, Reconstructive and Hand-SurgeryMaastricht University Medical CentreMaastricht, The Netherlands

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REFERENCES

1. Adams WP Jr, Culbertson EJ, Deva AK, et al. Macrotextured breast implants with defined steps to minimize bacterial contamination around the device: Experience in 42,000 implants. Plast Reconstr Surg. 2017;140:427431.
2. Hu H, Johani K, Almatroudi A, et al. Bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg. 2016;137:16591669.
3. de Boer M, van Leeuwen FE, Hauptmann M, et al. Breast implants and the risk of anaplastic large-cell lymphoma in the breast. JAMA Oncol. 2018;4:335341.
Copyright © 2018 by the American Society of Plastic Surgeons