Response to “Comments on ‘Long-Term Safety of Textured and Smooth Breast Implants’ and a Plea to Abandon the Use of the MAUDE Database”

Response to “Comments on ‘Long-Term Safety of Textured and Smooth Breast Implants’ and a... We thank Dr Edwards for his interest1 in our article describing the long-term safety of smooth and textured breast implants.2 The author accurately notes the limitations of the Manufacturer and User Facility Device Experience (MAUDE) database for estimating adverse event rates with medical devices, specifically breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Currently, reliable data on the incidence, risk factors, and etiology of BIA-ALCL are expanding but remain limited. Surgeons continue to pursue methods to identify, characterize, and track patients who develop BIA-ALCL following breast implant surgery. The PROFILE registry, described by Dr Edwards in his letter, is an important resource with recently presented data that may help to establish an improved understanding of this rare outcome.3 At the time of our manuscript, analysis of the MAUDE database represented one of the few sources that could provide perspective on the incidence of BIA-ALCL for surgeons and patients. As noted by the FDA, data from the MAUDE database should not be used alone to establish adverse event rates. In our report, we cite analyses of the MAUDE database in context with studies from multiple surgeons and researchers as a reference to one of the registries available. The many registries including the PROFILE registry will be essential as we continue to consolidate data and understand more about the prevalence, etiology, identification, management, and prevention of this disease entity. Our discussion of the different textured devices available and their individual incidence of adverse events was to emphasize that they should not be grouped as one in the same − they are manufactured differently, interact in the pocket differently and very clearly have different results and safety profiles. Indeed, we described the limitations of data derived from MAUDE and similar databases in our article and noted that the incidence of BIA-ALCL cannot be directly compared across manufacturers. Our goal was to advance the discussion of potential causative factors underlying BIA-ALCL and to facilitate communication of the benefits and risks of both smooth and textured implants to support informed decision making. It is our sincere hope that ongoing research efforts, including the PROFILE registry, will definitively describe the risk factors and incidence of BIA-ALCL, methods to prevent or limit this risk, and early screening and diagnostic protocols to identify affected patients. We concur that surgeons should be familiar with current methods for the diagnosis and management of BIA-ALCL in breast implant patients and included the NCCN Guidelines and ASPS/ASAPS Joint Statement and Algorithm in the article. We also agree that more reliable data are needed on the incidence and etiology of this rare but worrisome outcome. Disclosures The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. Funding The authors received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Edwards MC. Comments on “Long-Term Safety of Textured and Smooth Breast Implants” and a Plea to Abandon the Use of the MAUDE Database. Aesthet Surg J . 2018; 38( 3): N64- N65. 2. Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-term safety of textured and smooth breast implants. Aesthet Surg J . 2018; 38( 1): 38- 48. Google Scholar CrossRef Search ADS   3. McCarthy C. PSF Presidents Panel: ALCL Update. Presented at Plastic Surgery the Meeting in Orlando, FL, in October 2017. © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Aesthetic Surgery Journal Oxford University Press

Response to “Comments on ‘Long-Term Safety of Textured and Smooth Breast Implants’ and a Plea to Abandon the Use of the MAUDE Database”

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Publisher
Oxford University Press
Copyright
© 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com
ISSN
1090-820X
eISSN
1527-330X
D.O.I.
10.1093/asj/sjx269
Publisher site
See Article on Publisher Site

Abstract

We thank Dr Edwards for his interest1 in our article describing the long-term safety of smooth and textured breast implants.2 The author accurately notes the limitations of the Manufacturer and User Facility Device Experience (MAUDE) database for estimating adverse event rates with medical devices, specifically breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Currently, reliable data on the incidence, risk factors, and etiology of BIA-ALCL are expanding but remain limited. Surgeons continue to pursue methods to identify, characterize, and track patients who develop BIA-ALCL following breast implant surgery. The PROFILE registry, described by Dr Edwards in his letter, is an important resource with recently presented data that may help to establish an improved understanding of this rare outcome.3 At the time of our manuscript, analysis of the MAUDE database represented one of the few sources that could provide perspective on the incidence of BIA-ALCL for surgeons and patients. As noted by the FDA, data from the MAUDE database should not be used alone to establish adverse event rates. In our report, we cite analyses of the MAUDE database in context with studies from multiple surgeons and researchers as a reference to one of the registries available. The many registries including the PROFILE registry will be essential as we continue to consolidate data and understand more about the prevalence, etiology, identification, management, and prevention of this disease entity. Our discussion of the different textured devices available and their individual incidence of adverse events was to emphasize that they should not be grouped as one in the same − they are manufactured differently, interact in the pocket differently and very clearly have different results and safety profiles. Indeed, we described the limitations of data derived from MAUDE and similar databases in our article and noted that the incidence of BIA-ALCL cannot be directly compared across manufacturers. Our goal was to advance the discussion of potential causative factors underlying BIA-ALCL and to facilitate communication of the benefits and risks of both smooth and textured implants to support informed decision making. It is our sincere hope that ongoing research efforts, including the PROFILE registry, will definitively describe the risk factors and incidence of BIA-ALCL, methods to prevent or limit this risk, and early screening and diagnostic protocols to identify affected patients. We concur that surgeons should be familiar with current methods for the diagnosis and management of BIA-ALCL in breast implant patients and included the NCCN Guidelines and ASPS/ASAPS Joint Statement and Algorithm in the article. We also agree that more reliable data are needed on the incidence and etiology of this rare but worrisome outcome. Disclosures The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. Funding The authors received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Edwards MC. Comments on “Long-Term Safety of Textured and Smooth Breast Implants” and a Plea to Abandon the Use of the MAUDE Database. Aesthet Surg J . 2018; 38( 3): N64- N65. 2. Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-term safety of textured and smooth breast implants. Aesthet Surg J . 2018; 38( 1): 38- 48. Google Scholar CrossRef Search ADS   3. McCarthy C. PSF Presidents Panel: ALCL Update. Presented at Plastic Surgery the Meeting in Orlando, FL, in October 2017. © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

Journal

Aesthetic Surgery JournalOxford University Press

Published: Mar 1, 2018

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