Comments on "Long-Term Safety of Textured and Smooth Breast Implants" and a Plea to Abandon the Use of the MAUDE Database

Comments on "Long-Term Safety of Textured and Smooth Breast Implants" and a Plea to Abandon the... I would like to comment on the paper by Calobrace et al entitled “Long-Term Safety of Textured and Smooth Implants,” published in Aesthetic Surgery Journal.1 This paper provides a good overview of the evolution of implant textures and the difference in benefits, limitations, and patient selection between smooth and round implants. My main concern, in this paper and in some podium presentations on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), is the continued use of the Manufacturer and User Facility Device Experience (MAUDE) database in an attempt to describe the risks of BIA-ALCL, in spite of disclaimers. As listed on the Food and Drug Administration (FDA) website:2 Please note that the MAUDE web search feature is limited to adverse event reports within the past 10 years. MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions. Variations in trade, product, and company names affect search results. Searches only retrieve records that contain the search term(s) provided by the requester. Submission of a medical device report and the FDA’s release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event. Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by “(b)(4)”. If a report contains personnel or medical files information, that text is replaced by “(b)(6)”. The designations “(b)(4)” and “(b)(6)” refer to the exemptions in the FOIA. For example, “(b)(4)” may be found in place of the product’s composition and “(b)(6)” may be found in place of a patient’s age. MAUDE is updated monthly and the search page reflects the date of the most recent update. The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed. This is even more pertinent with the development of the PROFILE Registry,3 which serves as a comprehensive and accurate source when referring to the incidence of ALCL. The PROFILE Registry is a collaboration of the Plastic Surgery Foundation (PSF) and the FDA, and is “Open to all physicians who have a patient with breast implants that has a suspected or confirmed case of Breast Implant-Associated ALCL (BIA-ALCL).”3 To date, the PROFILE reports 160 unique cases in the United States as was recently presented at the 2017 ASPS Annual Meeting by the principal investigator Colleen McCarthy,4 and an update from the FDA is expected soon. No doubt with continued education and reporting, additional cases will be seen, hopefully providing more insight on how BIA-ALCL is treated and, hopefully in the future, how best to prevent it. Through continued education provided by ASPS and ASAPS, plastic surgeons should know presenting symptoms of ALCL, how to treat, and how to report to the PROFILE Registry so that we can continue to learn about this extremely rare phenomenon. My goal is not to restate the growing body of knowledge about ALCL. It is documented that ALCL has been seen in patients with textured implants manufactured by all three US manufacturers, and others internationally. No purpose is served, based upon the limited data that we have, trying to state one level of texturization is more causative than others based upon current day data. It may come to be that this or other causative factors are brought to light as more data come in, but we must be responsible in our reporting to our fellow plastic surgeons and the public what we know based on good solid science. I encourage all plastic surgeons who perform breast surgery to become familiar with the algorithmic approach to a patient with delayed seroma and suspected BIA-ALCL (see Figure 2 in Clemens et al5). Disclosures Dr Edwards is an Investigator and Consultant for Allergan (Irvine, CA); an Investigator for Mentor (Santa Barbara, CA) and Sientra (Santa Barbara, CA); a Consultant/Shareholder for TouchMD (Irvine, CA); and a Contributor/Shareholder for ExplainMySurgery.com (Las Vegas, NV). Funding The author received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-term safety of textured and smooth breast implants. Aesthet Surg J . 2017; 38( 1): 38- 48. Google Scholar CrossRef Search ADS PubMed  2. MAUDE - Manufacturer and User Facility Device Experience. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfmaude/search.cfm. Accessed October 20, 2017. 3. PROFILE | The Plastic Surgery Foundation. https://www.thepsf.org/research/registries/profile. Accessed October 20, 2017. 4. McCarthy C. PSF Presidents Panel: ALCL Update . Presented at Plastic Surgery the Meeting in Orlando, FL, in October 2017. 5. Clemens MW, Nava MB, Rocco N, Miranda RN. Understanding rare adverse sequelae of breast implants: anaplastic large-cell lymphoma, late seromas, and double capsules. Gland Surg . 2017; 6( 2): 169- 184. Google Scholar CrossRef Search ADS PubMed  © 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

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
Mosby Inc.
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/sjx219
Publisher site
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Abstract

I would like to comment on the paper by Calobrace et al entitled “Long-Term Safety of Textured and Smooth Implants,” published in Aesthetic Surgery Journal.1 This paper provides a good overview of the evolution of implant textures and the difference in benefits, limitations, and patient selection between smooth and round implants. My main concern, in this paper and in some podium presentations on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), is the continued use of the Manufacturer and User Facility Device Experience (MAUDE) database in an attempt to describe the risks of BIA-ALCL, in spite of disclaimers. As listed on the Food and Drug Administration (FDA) website:2 Please note that the MAUDE web search feature is limited to adverse event reports within the past 10 years. MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions. Variations in trade, product, and company names affect search results. Searches only retrieve records that contain the search term(s) provided by the requester. Submission of a medical device report and the FDA’s release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event. Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by “(b)(4)”. If a report contains personnel or medical files information, that text is replaced by “(b)(6)”. The designations “(b)(4)” and “(b)(6)” refer to the exemptions in the FOIA. For example, “(b)(4)” may be found in place of the product’s composition and “(b)(6)” may be found in place of a patient’s age. MAUDE is updated monthly and the search page reflects the date of the most recent update. The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed. This is even more pertinent with the development of the PROFILE Registry,3 which serves as a comprehensive and accurate source when referring to the incidence of ALCL. The PROFILE Registry is a collaboration of the Plastic Surgery Foundation (PSF) and the FDA, and is “Open to all physicians who have a patient with breast implants that has a suspected or confirmed case of Breast Implant-Associated ALCL (BIA-ALCL).”3 To date, the PROFILE reports 160 unique cases in the United States as was recently presented at the 2017 ASPS Annual Meeting by the principal investigator Colleen McCarthy,4 and an update from the FDA is expected soon. No doubt with continued education and reporting, additional cases will be seen, hopefully providing more insight on how BIA-ALCL is treated and, hopefully in the future, how best to prevent it. Through continued education provided by ASPS and ASAPS, plastic surgeons should know presenting symptoms of ALCL, how to treat, and how to report to the PROFILE Registry so that we can continue to learn about this extremely rare phenomenon. My goal is not to restate the growing body of knowledge about ALCL. It is documented that ALCL has been seen in patients with textured implants manufactured by all three US manufacturers, and others internationally. No purpose is served, based upon the limited data that we have, trying to state one level of texturization is more causative than others based upon current day data. It may come to be that this or other causative factors are brought to light as more data come in, but we must be responsible in our reporting to our fellow plastic surgeons and the public what we know based on good solid science. I encourage all plastic surgeons who perform breast surgery to become familiar with the algorithmic approach to a patient with delayed seroma and suspected BIA-ALCL (see Figure 2 in Clemens et al5). Disclosures Dr Edwards is an Investigator and Consultant for Allergan (Irvine, CA); an Investigator for Mentor (Santa Barbara, CA) and Sientra (Santa Barbara, CA); a Consultant/Shareholder for TouchMD (Irvine, CA); and a Contributor/Shareholder for ExplainMySurgery.com (Las Vegas, NV). Funding The author received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-term safety of textured and smooth breast implants. Aesthet Surg J . 2017; 38( 1): 38- 48. Google Scholar CrossRef Search ADS PubMed  2. MAUDE - Manufacturer and User Facility Device Experience. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfmaude/search.cfm. Accessed October 20, 2017. 3. PROFILE | The Plastic Surgery Foundation. https://www.thepsf.org/research/registries/profile. Accessed October 20, 2017. 4. McCarthy C. PSF Presidents Panel: ALCL Update . Presented at Plastic Surgery the Meeting in Orlando, FL, in October 2017. 5. Clemens MW, Nava MB, Rocco N, Miranda RN. Understanding rare adverse sequelae of breast implants: anaplastic large-cell lymphoma, late seromas, and double capsules. Gland Surg . 2017; 6( 2): 169- 184. Google Scholar CrossRef Search ADS PubMed  © 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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