Response to “Why the Micromort Concept Falls Short in Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk Analysis”

Response to “Why the Micromort Concept Falls Short in Breast Implant-Associated Anaplastic... Although I do want to thank you for your Letter to the Editor entitled, “Why the Micromort Concept Falls Short in Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk Analysis,” I disagree with the concepts introduced in it.1 The authors begin their article discussing 7 deaths in 1982 Chicago caused by Tylenol laced with cyanide, resulting in a $100 million dollar recall. They then go on to cite a micromort related to this event of 0.14. Since a micromort is a calculation based on risk/event, the authors must not have understood this as the comparison between Tylenol poisoning and BIA-ALCL does not hold up. In order for a micromort to be established there needs to be a death rate per event. The simple act of taking Tylenol does not result in death. The authors then go on to discuss another recall of Takata airbags which resulted in a $1 billion dollar fine to the company. These defective airbags caused 11 deaths and 184 injuries. From these data the authors calculated a micromort of 0.26. Again, this micromort calculation is not correct as it needs to be based on the number of airbags deployed and not the total number of airbags. If following the authors’ logic, it would seem as though they are suggesting that all women with textured implants should have them removed. This would result in removal of 70 million implants, almost all of which will never cause any issues for the patient during her lifetime. Should we never again drink wine, drive in a car, or walk as well? Finally the authors discuss the emotional trauma of patients diagnosed with BIA-ALCL stating that the their breasts are “scarred and deflated” after appropriate treatment with capsulectomy.2 This again is not true as many women are able to have new implants placed at the time of surgery, leaving them with a similar breast size and shape prior to surgery. Data thus far have shown that patients who are diagnosed in a timely manner are best treated with only a capsulectomy without any additional treatment.3 The incidence of advanced disease in patients with BIA-ALCL is exceedingly rare. For the authors to ignore already published data suggesting the lymphoproliferative nature of BIA-ALCL is ignorant. Plastic surgeons should never be insensitive to a problem, but instead should be well educated on the data available. The purpose of the micromort concept is for patient education on relative risk. The authors discuss the point that people understand the risk of riding in a car or in an airplane before willingly boarding, but do they? According to 2014 data the lifetime risk of dying from a motor vehicle accident (MVA) is 1 in 114 while the lifetime risk of dying in an air and space transport accident is 1 in 9821.4 So despite the greater risk of death from a MVA, many people are more afraid to fly then they are to travel in a car! We agree with the inference that people should understand risk associated with their car, planes, as well as their textured implants. The one point the authors are missing is that there is big difference between being diagnosed with BIA-ALCL and dying from BIA-ALCL. The micromort risk of the McGuire study cited is 0 because although there were women diagnosed with BIA-ALCL, none of them died from the disease.5 It’s for this reason we compare BIA-ALCL to skin cancer, as the diagnosis does not necessarily portray an increased risk of death because the vast majority of cases are treated early and completely. The currently discussed risk from dying from a Brazilian butt lift is 1 in 6200,6 yet people continue to perform these on a regular basis.7 We as plastic surgeons have a need to read and understand the current research on hot topics. We need to be able to synthesize this information and convey it to our patients in a manner that they will understand. The micromort concept is one that is easy to explain to patients, allowing them to understand their risk as it relates to textured implants and BIA-ALCL. I for one will continue to drive to work, take my dogs for long walks, and enjoy my red wine! 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. Swanson E, Mackay DR. Why the micromort concept falls short in breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) risk analysis. Aesthet Surg J . 2018. doi: 10.1093/asj/sjx237. 2. Clemens MW, Horwitz SM. NCCN consensus guidelines for the diagnosis and management of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J . 2017; 37( 3): 285- 289. Google Scholar CrossRef Search ADS PubMed  3. Clemens MW, Medeiros LJ, Butler CEet al.   Complete surgical excision is essential for the management of patients with breast implant-associated anaplastic large-cell lymphoma. J Clin Oncol . 2016; 34( 2): 160- 168. Google Scholar CrossRef Search ADS PubMed  4. Facts + Statistics: Mortality risk. https://www.iii.org/fact-statistic/facts-statistics-mortality-risk. Accessed December 15, 2017. 5. McGuire P, Reisman NR, Murphy DK. Risk factor analysis for capsular contracture, malposition, and late seroma in subjects receiving natrelle 410 form-stable silicone breast implants. Plast Reconstr Surg . 2017; 139( 1): 1- 9. Google Scholar CrossRef Search ADS PubMed  6. Mofid MM, Teitelbaum S, Suissa Det al.   Report on mortality from gluteal fat grafting: recommendations from the ASERF task force. Aesthet Surg J . 2017; 37( 7): 796- 806. Google Scholar CrossRef Search ADS PubMed  7. Cosmetic surgery national data bank statistics. Aesthet Surg J . 2017; 37( suppl 2): 1- 29. © 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 “Why the Micromort Concept Falls Short in Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk Analysis”

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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/sjx266
Publisher site
See Article on Publisher Site

Abstract

Although I do want to thank you for your Letter to the Editor entitled, “Why the Micromort Concept Falls Short in Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk Analysis,” I disagree with the concepts introduced in it.1 The authors begin their article discussing 7 deaths in 1982 Chicago caused by Tylenol laced with cyanide, resulting in a $100 million dollar recall. They then go on to cite a micromort related to this event of 0.14. Since a micromort is a calculation based on risk/event, the authors must not have understood this as the comparison between Tylenol poisoning and BIA-ALCL does not hold up. In order for a micromort to be established there needs to be a death rate per event. The simple act of taking Tylenol does not result in death. The authors then go on to discuss another recall of Takata airbags which resulted in a $1 billion dollar fine to the company. These defective airbags caused 11 deaths and 184 injuries. From these data the authors calculated a micromort of 0.26. Again, this micromort calculation is not correct as it needs to be based on the number of airbags deployed and not the total number of airbags. If following the authors’ logic, it would seem as though they are suggesting that all women with textured implants should have them removed. This would result in removal of 70 million implants, almost all of which will never cause any issues for the patient during her lifetime. Should we never again drink wine, drive in a car, or walk as well? Finally the authors discuss the emotional trauma of patients diagnosed with BIA-ALCL stating that the their breasts are “scarred and deflated” after appropriate treatment with capsulectomy.2 This again is not true as many women are able to have new implants placed at the time of surgery, leaving them with a similar breast size and shape prior to surgery. Data thus far have shown that patients who are diagnosed in a timely manner are best treated with only a capsulectomy without any additional treatment.3 The incidence of advanced disease in patients with BIA-ALCL is exceedingly rare. For the authors to ignore already published data suggesting the lymphoproliferative nature of BIA-ALCL is ignorant. Plastic surgeons should never be insensitive to a problem, but instead should be well educated on the data available. The purpose of the micromort concept is for patient education on relative risk. The authors discuss the point that people understand the risk of riding in a car or in an airplane before willingly boarding, but do they? According to 2014 data the lifetime risk of dying from a motor vehicle accident (MVA) is 1 in 114 while the lifetime risk of dying in an air and space transport accident is 1 in 9821.4 So despite the greater risk of death from a MVA, many people are more afraid to fly then they are to travel in a car! We agree with the inference that people should understand risk associated with their car, planes, as well as their textured implants. The one point the authors are missing is that there is big difference between being diagnosed with BIA-ALCL and dying from BIA-ALCL. The micromort risk of the McGuire study cited is 0 because although there were women diagnosed with BIA-ALCL, none of them died from the disease.5 It’s for this reason we compare BIA-ALCL to skin cancer, as the diagnosis does not necessarily portray an increased risk of death because the vast majority of cases are treated early and completely. The currently discussed risk from dying from a Brazilian butt lift is 1 in 6200,6 yet people continue to perform these on a regular basis.7 We as plastic surgeons have a need to read and understand the current research on hot topics. We need to be able to synthesize this information and convey it to our patients in a manner that they will understand. The micromort concept is one that is easy to explain to patients, allowing them to understand their risk as it relates to textured implants and BIA-ALCL. I for one will continue to drive to work, take my dogs for long walks, and enjoy my red wine! 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. Swanson E, Mackay DR. Why the micromort concept falls short in breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) risk analysis. Aesthet Surg J . 2018. doi: 10.1093/asj/sjx237. 2. Clemens MW, Horwitz SM. NCCN consensus guidelines for the diagnosis and management of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J . 2017; 37( 3): 285- 289. Google Scholar CrossRef Search ADS PubMed  3. Clemens MW, Medeiros LJ, Butler CEet al.   Complete surgical excision is essential for the management of patients with breast implant-associated anaplastic large-cell lymphoma. J Clin Oncol . 2016; 34( 2): 160- 168. Google Scholar CrossRef Search ADS PubMed  4. Facts + Statistics: Mortality risk. https://www.iii.org/fact-statistic/facts-statistics-mortality-risk. Accessed December 15, 2017. 5. McGuire P, Reisman NR, Murphy DK. Risk factor analysis for capsular contracture, malposition, and late seroma in subjects receiving natrelle 410 form-stable silicone breast implants. Plast Reconstr Surg . 2017; 139( 1): 1- 9. Google Scholar CrossRef Search ADS PubMed  6. Mofid MM, Teitelbaum S, Suissa Det al.   Report on mortality from gluteal fat grafting: recommendations from the ASERF task force. Aesthet Surg J . 2017; 37( 7): 796- 806. Google Scholar CrossRef Search ADS PubMed  7. Cosmetic surgery national data bank statistics. Aesthet Surg J . 2017; 37( suppl 2): 1- 29. © 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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