539700
research-article2014
AESXXX10.1177/1090820X14539700Aesthetic Surgery JournalReisman
Editorial
Breast Implant–Associated Anaplastic Large Cell Lymphoma: What We Can Do
Aesthetic Surgery Journal 2014, Vol. 34(6) 956–958 © 2014 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: http://www.sagepub.com/ journalsPermissions.nav DOI: 10.1177/1090820X14539700 www.aestheticsurgeryjournal.com
Neal R. Reisman, MD, JD, FACS Although anaplastic large cell lymphoma (ALCL) associated with breast implants is a rare finding, it has recently become better recognized according to reports of between 62 and 100 cases worldwide, not all of them confirmed. In March 2014, I had the opportunity to attend a Scientific Advisory Panel on ALCL association with breast implants, convened by the RAND Corporation (a nonprofit, nonpartisan research organization)1 at its Arlington, Virginia, office. Commissioned by the Plastic Surgery Foundation (formerly Plastic Surgery Educational Foundation) and the Aesthetic Surgery Education and Research Foundation, the RAND Corporation had convened a similar panel in 2011 and released key findings of a review of published ALCL cases.2 The 2-day meeting in 2014 included 13 multidisciplinary experts reviewing the latest information on ALCL involving the breast in women with breast implants and updating recommendations for evaluation, treatment, and follow-up of women presenting with this disease. I do not wish to preempt the RAND Corporation’s own release of these proceedings, which are forthcoming. However, I will briefly summarize what we as plastic surgeons can do to appropriately manage patient discussions and care and to move forward with the investigation of breast implant– associated ALCL.
Preoperative Patient Discussions Breast implant surgery, whether cosmetic or reconstructive, has perhaps received more attention from a patient education standpoint than any other procedure that plastic surgeons routinely perform. ALCL in the breast is extremely uncommon. According to the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute, approximately 3 in 100 million women receive this diagnosis each year in the United States. However, the data pertaining specifically to women with breast implants currently indicate a somewhat higher-than-expected incidence, suggesting that breast implant–associated ALCL is a real entity. Furthermore, the US Food and Drug Administration (FDA) reports that, while still under study, there appears to be a fairly consistent
pattern to the reported cases.3 These findings have encouraged some experts to develop a preliminary consensus regarding specific diagnostic evaluations and/or treatments to be considered in patients with breast implants who present with a late seroma and/or capsular mass. In general, the management of any postoperative problem is thought to proceed more smoothly if the patient had been advised preoperatively, as precisely as possible, of what would be involved should a given complication occur.4 Based on our current knowledge of ALCL, an important discussion point for prospective and current patients with breast implants would be the potential cost of diagnostic studies should a seroma occur. It is also vital for patients to understand the necessity of returning for follow-up—both short- and long-term—since their plastic surgeon may be the specialist most knowledgeable about this rare disease process as well as the person most appropriate to coordinate the necessary evaluation and treatment. Of course, there are many reasons why follow-up of breast implant patients is recommended, and these should be emphasized so that patients gain a balanced perspective on the range of their continuing care as implant recipients. Finally, the FDA currently asserts that because the risk of ALCL appears very small, “the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.”3 Plastic surgeons should be aware that even though textured implants appear to be more commonly associated with the disease, no causal relationship has been determined.3 Moreover, experts are uncertain whether other factors might influence the risk of developing ALCL in women with breast Dr Reisman is Chief of Plastic Surgery at Baylor–St Luke’s Medical Center; Director of Aesthetic Surgery, Division of Plastic Surgery, and Professor of Plastic Surgery, Baylor College of Medicine; and an attorney at law. Corresponding Author: Neal R. Reisman, MD, JD, FACS, 6624 Fannin Street, Suite 2390, Houston, TX 77030, USA. E-mail: [email protected]
Reisman 957
implants, such as family history, genetics, obesity, and/or smoking.2 Discussions have included the possibility of etiologic factors related to the body’s response to implanted biomaterials or, considering the local environment of the breast, to the presence of biofilm.5 However, such possibilities remain hypothetical. There is no certainty about the specific causeand-effect relationship between breast implants and ALCL.
Evaluation in Collaboration With Pathology and Oncology It is recommended that plastic surgeons be proactive in discussions with all potential members of the treatment team, including pathologists, oncologists, and other appropriate medical specialists. Because ALCL associated with breast implants is very rare, some centers may not have encountered it. In such instances, it may be wise to encourage team members to refer the case to individuals who have experience with the specific disease process, all of which would be protected by the Health Insurance Portability and Accountability Act. Patients may present with a periprosthetic seroma or fluid collection 6 months or more following implant placement. The RAND panel discussed an average range of 4 to 7 years following implantation, which would not denote an early seroma. An appropriate workup might include an evaluation for infection and trauma. Ultrasonography may be useful to evaluate the pocket and safe aspiration for cytology, to include CD30 antigen and ALK gene testing, cell block, and exploration for the presence of a capsular mass or lymph node involvement. Because it may be difficult to collect or isolate free-floating tumor cells in the seroma fluid, sending as much fluid as possible for evaluation will help to ensure an adequate amount for diagnostic purposes. It is suggested to alert the pathologist that the tissue and fluid being sent are to be evaluated specifically for breast implant–associated ALCL. The RAND panel noted 2 courses of presentation with apparently different outcomes. In the patient with no capsular invasion of ALCL cells and with the absence of extracapsular involvement (eg, in lymph nodes), the disease appears to have a more indolent course. Although standards for treatment have not yet been established, some experts have suggested that patients in this group undergo total capsulectomy, implant removal, and complete pathologic evaluation of all submitted tissue. In consultation with an appropriate oncologist, it may be determined that no further treatment is necessary if there is no evidence of extracapsular invasion. A formal discussion among the treatment team, including the patient, can help determine whether or not to proceed with reimplantation. In the much smaller group of patients who present with capsular invasion or extracapsular disease, such as distant or axillary lymph node involvement, the course of disease
progression appears to be more severe. Full consultation with knowledgeable ALCL experts is imperative. Additional treatments beyond total capsulectomy and implant removal may be warranted.
Follow-up Care As stated earlier, follow-up care for all breast implant patients cannot be overemphasized. Because ALCL can occur many years after implantation, patients should be encouraged to schedule annual follow-up examinations with their plastic surgeon. For patients who have undergone removal of an implant and capsule due to the diagnosis of ALCL, continued follow-up is essential, despite the fact that some experts believe that there is a low risk for recurrence or systemic disease in cases without capsular invasion or extracapsular disease. Patients whose disease requires treatment beyond total capsulectomy and implant removal will, of course, need ongoing care from the treatment team.
Continuing Research: How to Report Cases to the FDA One of the most important things that we as plastic surgeons can do is support the continued investigation of breast implant–associated ALCL. As noted by Hart et al in this issue of Aesthetic Surgery Journal (“Breast Implant– Associated Anaplastic Large Cell Lymphoma: Report of 2 Cases and Review of the Literature”), the epidemiologic studies thus far have included too few ALCL patients with breast implants to determine a definitive assessment of risk.6 In conjunction with the RAND Corporation, the American Society for Aesthetic Plastic Surgery asked 5468 plastic surgeons to participate anonymously in an e-mail survey distributed on March 18, 2014. The survey contained questions about ALCL involving the breast in women with breast implants, including whether the surgeon had treated a patient with the disease in his or her practice, as well as the presentation, treatment, follow-up, and outcomes. Of the 663 surgeons who responded (as of this writing), 53 (7.99%) had personally treated a breast implant patient for ALCL involving the breast (V. Leroy Young, MD, FACS, personal communication, May 15, 2014). The complete survey results are being analyzed and will be discussed in an upcoming publication. If a patient is diagnosed through your practice, please be sure to report the case to the FDA so that confirmed cases can be compiled and further analyzed.7 Your voluntary report can be filed through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program, either online or by calling 1-800-332-1088.8 The FDA states on its website that all filed reports are confidential and that
958
appropriate measures have been taken to protect patient privacy. Specific details of the information that you should provide to the FDA can be found at http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm240000. htm#howtoreport. Awareness of the possible presentation of breast implant–associated ALCL is vital for every plastic surgeon, as is an updated algorithm for treatment. (Remember to watch for the RAND Corporation’s report on the second Scientific Advisory Panel meeting, at http://www.rand .org.) Despite the likelihood that you may never encounter a patient with this disease, you have a responsibility to educate yourself and your patients about the risks. Given that ALCL appears to be rare among women with breast implants, its possibility should not provoke undue anxiety, but it should also not be ignored when potential symptoms are present. Swift and effective diagnostic measures are always in the best interest of the patient and the surgeon.
Disclosures The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.
References 1. RAND Corporation. About the RAND Corporation. http:// www.rand.org/about.html. Accessed May 13, 2014.
Aesthetic Surgery Journal 34(6) 2. RAND Corporation. Are breast implants linked to a rare form of lymphoma? http://www.rand.org/pubs/research_briefs/ RB9584/index1.html. Accessed May 14, 2014. 3. US Food and Drug Administration. Anaplastic large cell lymphoma (ALCL) in women with breast implants: preliminary FDA findings and analyses. http://www.fda .gov/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/BreastImplants/ucm239996.htm. Accessed May 14, 2014. 4. Adams WP, Bengston BP, Glicksman CA, et al. Decision and management algorithms to address patient and food and drug administration concerns regarding breast augmentation and implants. Plast Reconstr Surg. 2004;114:1252-1257. 5. Nahabedian MY. Discussion: anaplastic large cell lymphoma and breast implants: results from a structured expert consultation process. Plast Reconstr Surg. 2011;128: 540-642. 6. Hart AM, Lechowicz MJ, Peters KK, Holden J, Carlson GW. Breast implant–associated anaplastic large cell lymphoma: report of 2 cases and review of the literature [published online ahead of print June 17, 2014]. Aesthet Surg J. doi: 10.1177/1090820X14539503. 7. Eaves F, Nahai F. Anaplastic large cell lymphoma and breast implants: FDA report. Aesthet Surg J. 2011;31:467-468. 8. US Food and Drug Administration. FDA medical device safety communication: reports of anaplastic large cell lymphoma (ALCL) in women with breast implants. http:// www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ ucm240000.htm#howtoreport. Accessed May 13, 2014.
research-article2014
AESXXX10.1177/1090820X14539700Aesthetic Surgery JournalReisman
Editorial
Breast Implant–Associated Anaplastic Large Cell Lymphoma: What We Can Do
Aesthetic Surgery Journal 2014, Vol. 34(6) 956–958 © 2014 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: http://www.sagepub.com/ journalsPermissions.nav DOI: 10.1177/1090820X14539700 www.aestheticsurgeryjournal.com
Neal R. Reisman, MD, JD, FACS Although anaplastic large cell lymphoma (ALCL) associated with breast implants is a rare finding, it has recently become better recognized according to reports of between 62 and 100 cases worldwide, not all of them confirmed. In March 2014, I had the opportunity to attend a Scientific Advisory Panel on ALCL association with breast implants, convened by the RAND Corporation (a nonprofit, nonpartisan research organization)1 at its Arlington, Virginia, office. Commissioned by the Plastic Surgery Foundation (formerly Plastic Surgery Educational Foundation) and the Aesthetic Surgery Education and Research Foundation, the RAND Corporation had convened a similar panel in 2011 and released key findings of a review of published ALCL cases.2 The 2-day meeting in 2014 included 13 multidisciplinary experts reviewing the latest information on ALCL involving the breast in women with breast implants and updating recommendations for evaluation, treatment, and follow-up of women presenting with this disease. I do not wish to preempt the RAND Corporation’s own release of these proceedings, which are forthcoming. However, I will briefly summarize what we as plastic surgeons can do to appropriately manage patient discussions and care and to move forward with the investigation of breast implant– associated ALCL.
Preoperative Patient Discussions Breast implant surgery, whether cosmetic or reconstructive, has perhaps received more attention from a patient education standpoint than any other procedure that plastic surgeons routinely perform. ALCL in the breast is extremely uncommon. According to the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute, approximately 3 in 100 million women receive this diagnosis each year in the United States. However, the data pertaining specifically to women with breast implants currently indicate a somewhat higher-than-expected incidence, suggesting that breast implant–associated ALCL is a real entity. Furthermore, the US Food and Drug Administration (FDA) reports that, while still under study, there appears to be a fairly consistent
pattern to the reported cases.3 These findings have encouraged some experts to develop a preliminary consensus regarding specific diagnostic evaluations and/or treatments to be considered in patients with breast implants who present with a late seroma and/or capsular mass. In general, the management of any postoperative problem is thought to proceed more smoothly if the patient had been advised preoperatively, as precisely as possible, of what would be involved should a given complication occur.4 Based on our current knowledge of ALCL, an important discussion point for prospective and current patients with breast implants would be the potential cost of diagnostic studies should a seroma occur. It is also vital for patients to understand the necessity of returning for follow-up—both short- and long-term—since their plastic surgeon may be the specialist most knowledgeable about this rare disease process as well as the person most appropriate to coordinate the necessary evaluation and treatment. Of course, there are many reasons why follow-up of breast implant patients is recommended, and these should be emphasized so that patients gain a balanced perspective on the range of their continuing care as implant recipients. Finally, the FDA currently asserts that because the risk of ALCL appears very small, “the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.”3 Plastic surgeons should be aware that even though textured implants appear to be more commonly associated with the disease, no causal relationship has been determined.3 Moreover, experts are uncertain whether other factors might influence the risk of developing ALCL in women with breast Dr Reisman is Chief of Plastic Surgery at Baylor–St Luke’s Medical Center; Director of Aesthetic Surgery, Division of Plastic Surgery, and Professor of Plastic Surgery, Baylor College of Medicine; and an attorney at law. Corresponding Author: Neal R. Reisman, MD, JD, FACS, 6624 Fannin Street, Suite 2390, Houston, TX 77030, USA. E-mail: [email protected]
Reisman 957
implants, such as family history, genetics, obesity, and/or smoking.2 Discussions have included the possibility of etiologic factors related to the body’s response to implanted biomaterials or, considering the local environment of the breast, to the presence of biofilm.5 However, such possibilities remain hypothetical. There is no certainty about the specific causeand-effect relationship between breast implants and ALCL.
Evaluation in Collaboration With Pathology and Oncology It is recommended that plastic surgeons be proactive in discussions with all potential members of the treatment team, including pathologists, oncologists, and other appropriate medical specialists. Because ALCL associated with breast implants is very rare, some centers may not have encountered it. In such instances, it may be wise to encourage team members to refer the case to individuals who have experience with the specific disease process, all of which would be protected by the Health Insurance Portability and Accountability Act. Patients may present with a periprosthetic seroma or fluid collection 6 months or more following implant placement. The RAND panel discussed an average range of 4 to 7 years following implantation, which would not denote an early seroma. An appropriate workup might include an evaluation for infection and trauma. Ultrasonography may be useful to evaluate the pocket and safe aspiration for cytology, to include CD30 antigen and ALK gene testing, cell block, and exploration for the presence of a capsular mass or lymph node involvement. Because it may be difficult to collect or isolate free-floating tumor cells in the seroma fluid, sending as much fluid as possible for evaluation will help to ensure an adequate amount for diagnostic purposes. It is suggested to alert the pathologist that the tissue and fluid being sent are to be evaluated specifically for breast implant–associated ALCL. The RAND panel noted 2 courses of presentation with apparently different outcomes. In the patient with no capsular invasion of ALCL cells and with the absence of extracapsular involvement (eg, in lymph nodes), the disease appears to have a more indolent course. Although standards for treatment have not yet been established, some experts have suggested that patients in this group undergo total capsulectomy, implant removal, and complete pathologic evaluation of all submitted tissue. In consultation with an appropriate oncologist, it may be determined that no further treatment is necessary if there is no evidence of extracapsular invasion. A formal discussion among the treatment team, including the patient, can help determine whether or not to proceed with reimplantation. In the much smaller group of patients who present with capsular invasion or extracapsular disease, such as distant or axillary lymph node involvement, the course of disease
progression appears to be more severe. Full consultation with knowledgeable ALCL experts is imperative. Additional treatments beyond total capsulectomy and implant removal may be warranted.
Follow-up Care As stated earlier, follow-up care for all breast implant patients cannot be overemphasized. Because ALCL can occur many years after implantation, patients should be encouraged to schedule annual follow-up examinations with their plastic surgeon. For patients who have undergone removal of an implant and capsule due to the diagnosis of ALCL, continued follow-up is essential, despite the fact that some experts believe that there is a low risk for recurrence or systemic disease in cases without capsular invasion or extracapsular disease. Patients whose disease requires treatment beyond total capsulectomy and implant removal will, of course, need ongoing care from the treatment team.
Continuing Research: How to Report Cases to the FDA One of the most important things that we as plastic surgeons can do is support the continued investigation of breast implant–associated ALCL. As noted by Hart et al in this issue of Aesthetic Surgery Journal (“Breast Implant– Associated Anaplastic Large Cell Lymphoma: Report of 2 Cases and Review of the Literature”), the epidemiologic studies thus far have included too few ALCL patients with breast implants to determine a definitive assessment of risk.6 In conjunction with the RAND Corporation, the American Society for Aesthetic Plastic Surgery asked 5468 plastic surgeons to participate anonymously in an e-mail survey distributed on March 18, 2014. The survey contained questions about ALCL involving the breast in women with breast implants, including whether the surgeon had treated a patient with the disease in his or her practice, as well as the presentation, treatment, follow-up, and outcomes. Of the 663 surgeons who responded (as of this writing), 53 (7.99%) had personally treated a breast implant patient for ALCL involving the breast (V. Leroy Young, MD, FACS, personal communication, May 15, 2014). The complete survey results are being analyzed and will be discussed in an upcoming publication. If a patient is diagnosed through your practice, please be sure to report the case to the FDA so that confirmed cases can be compiled and further analyzed.7 Your voluntary report can be filed through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program, either online or by calling 1-800-332-1088.8 The FDA states on its website that all filed reports are confidential and that
958
appropriate measures have been taken to protect patient privacy. Specific details of the information that you should provide to the FDA can be found at http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm240000. htm#howtoreport. Awareness of the possible presentation of breast implant–associated ALCL is vital for every plastic surgeon, as is an updated algorithm for treatment. (Remember to watch for the RAND Corporation’s report on the second Scientific Advisory Panel meeting, at http://www.rand .org.) Despite the likelihood that you may never encounter a patient with this disease, you have a responsibility to educate yourself and your patients about the risks. Given that ALCL appears to be rare among women with breast implants, its possibility should not provoke undue anxiety, but it should also not be ignored when potential symptoms are present. Swift and effective diagnostic measures are always in the best interest of the patient and the surgeon.
Disclosures The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.
References 1. RAND Corporation. About the RAND Corporation. http:// www.rand.org/about.html. Accessed May 13, 2014.
Aesthetic Surgery Journal 34(6) 2. RAND Corporation. Are breast implants linked to a rare form of lymphoma? http://www.rand.org/pubs/research_briefs/ RB9584/index1.html. Accessed May 14, 2014. 3. US Food and Drug Administration. Anaplastic large cell lymphoma (ALCL) in women with breast implants: preliminary FDA findings and analyses. http://www.fda .gov/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/BreastImplants/ucm239996.htm. Accessed May 14, 2014. 4. Adams WP, Bengston BP, Glicksman CA, et al. Decision and management algorithms to address patient and food and drug administration concerns regarding breast augmentation and implants. Plast Reconstr Surg. 2004;114:1252-1257. 5. Nahabedian MY. Discussion: anaplastic large cell lymphoma and breast implants: results from a structured expert consultation process. Plast Reconstr Surg. 2011;128: 540-642. 6. Hart AM, Lechowicz MJ, Peters KK, Holden J, Carlson GW. Breast implant–associated anaplastic large cell lymphoma: report of 2 cases and review of the literature [published online ahead of print June 17, 2014]. Aesthet Surg J. doi: 10.1177/1090820X14539503. 7. Eaves F, Nahai F. Anaplastic large cell lymphoma and breast implants: FDA report. Aesthet Surg J. 2011;31:467-468. 8. US Food and Drug Administration. FDA medical device safety communication: reports of anaplastic large cell lymphoma (ALCL) in women with breast implants. http:// www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ ucm240000.htm#howtoreport. Accessed May 13, 2014.
