Discussion Discussion: International Importance of Robust Breast Device Registries Maurice Y. Nahabedian, M.D. Washington, D.C.
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n this article, “International Importance of Robust Breast Device Registries,” the authors advocate for the establishment of national breast implant registries with global collaboration.1 The impetus for creation of a registry is once again relevant because of the Poly Implant Prothèse implant crisis. The lack of a robust registry prevented agencies from identifying the issue early, and complicated the collection of patients that had these devices implanted. The crisis gained widespread media attention and, much like the silicone gel implant crisis of the 1990s, created negative publicity. As such, national registries with global collaboration are being proposed to enhance quality outcome tracking and to provide evidence-based international tracking systems to prevent these crises from occurring. The concept of national breast implant registries with global collaboration should be met with enthusiasm. In the United States, there is no effective system of device monitoring or tracking. Records of implanted devices are retained by individual surgeons and manufacturers. Limited tracking has been performed by manufacturers through the Core studies that have been minimally beneficial because they have included only a small number of plastic surgeons and are currently closed for new surgeons. These Core studies are all further limited by low patient accrual, with only several hundred women enrolled. To extrapolate what is occurring in a sample of several hundred patients when hundreds of thousands of breast implants are placed annually in the United States and over 1 million are implanted globally seems inadequate. The establishment of a global registry will permit accrual of thousands of patients within a short timeframe that would be evidence based and less subject to biased interpretation and analysis. Registry oversight should be through a From the Department of Plastic Surgery, Georgetown University. Received for publication September 10, 2014; accepted September 12, 2014. Copyright © 2015 by the American Society of Plastic Surgeons DOI: 10.1097/PRS.0000000000000921
collaborative group of individuals consisting of surgeons, industry representatives, government officials, and insurers. The benefits of a robust registry are that it will establish benchmarks for outcomes both desirable and otherwise. Implanted devices that fail to meet the criteria for safety and efficacy will be identified early, before hundreds of thousands of women are implanted with them. The other aspect of a national registry will be that surgeons will know where they stand in comparison with other surgeons when it comes to reoperations or adverse events. The incidence of adverse events, device failure, and poor outcomes is greater than one would expect. All one needs to do is look at the Core study outcomes to see that reoperation rates and adverse events are higher than we think they should be. Ironically, most of the surgeon participants in the Core studies are the “expert” surgeons that tend to have the best outcomes. I hope that all surgeons participate in the registry and choose not to opt out. Reasons to opt out may include additional paperwork, additional time, possible fees, and the fear that their personal outcomes would be tracked and monitored. Plastic surgeons are becoming increasingly competitive, and to have performance benchmarked and compared with other plastic surgeons may be perceived as a deterrent. I suspect that most patients would be in favor of a national registry and not object to automatic inclusion, because it is being implemented to ensure their safety and the safety of future generations. Spreading the word about these registries should be through the media, the Internet, medical conferences, various women’s organizations, and journals. In essence, the registries would serve as a quality collaborative among all surgeons that will ultimately serve our patients better. The anaplastic large-cell lymphoma issue is another implant-related event that needs to be Disclosure: Dr. Nahabedian is a consultant and speaker for LifeCell, Sientra, and Allergan, but has had no support or direction from these companies in preparing this Discussion.
www.PRSJournal.com
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Plastic and Reconstructive Surgery • February 2015 monitored closely. Had a globally robust implant registry been established earlier, one could argue that the incidence and trends associated with anaplastic large-cell lymphoma and prosthetic devices would be better understood. Tracking outcomes by means of registries is not a novel concept. In addition to the orthopedic registry, other specialties performing highrisk procedures are adopting mechanisms to track outcomes. A quality collaborative has been adopted by several members of the Americas Hernia Society as a means of improving outcomes. Complex abdominal wall reconstruction has been historically associated with poor outcomes. With this voluntary quality collaborative, outcomes are tracked for all participating surgeons with the ultimate goal of optimizing outcomes for all. In summary, plastic surgery needs accurate, reliable, real-time data that are evidence based and that have not been misinterpreted. National
registries with global collaboration are clearly a first step. Plastic surgery needs to be proactive and not retroactive as is often the case when it comes to a crisis. The silicone gel implant crisis of the 1990s and more recently the Poly Implant Prothèse debacle have demonstrated that an organized and well-managed registry is necessary. Plastic surgeons around the world should embrace the global registry initiative.
FILLER-014 Maurice Y. Nahabedian, M.D. Department of Plastic Surgery Georgetown University 3800 Reservoir Road NW Washington, D.C. 20007 [email protected]
REFERENCE 1. Cooter RD, Barker S, Carroll SM, et al. International importance of robust breast device registries. Plast Reconstr Surg. 2015;135:330–336.
Online CME Collections This partial list of titles in the developing archive of CME article collections is available online at www. PRSJournal.com. These articles are suitable to use as study guides for board certification, to help readers refamiliarize themselves on a particular topic, or to serve as useful reference articles. Articles less than 3 years old can be taken for CME credit. Breast Current Trends in Breast Reduction—David A. Hidalgo et al. Benign Tumors of the Teenage Breast—Mary H. McGrath Breast Reconstruction with Implants and Expanders—Scott L. Spear and Christopher J. Spittler Breast Cancer: Advances in Surgical Management —Alan R. Shons and Charles E. Cox Breast Reconstruction with Free Tissue Transfer—Michael S. Beckenstein and James C. Grotting Recurrent Mammary Hyperplasia: Current Concepts—Rod J. Rohrich et al. Evolution of the Vertical Reduction Mammaplasty—Scott L. Spear and Michael A. Howard Breast Augmentation—Cancer Concerns and Mammography: A Literature Review—Michael G. Jakubietz et al. Breast Augmentation—Scott L. Spear et al.
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I
n this article, “International Importance of Robust Breast Device Registries,” the authors advocate for the establishment of national breast implant registries with global collaboration.1 The impetus for creation of a registry is once again relevant because of the Poly Implant Prothèse implant crisis. The lack of a robust registry prevented agencies from identifying the issue early, and complicated the collection of patients that had these devices implanted. The crisis gained widespread media attention and, much like the silicone gel implant crisis of the 1990s, created negative publicity. As such, national registries with global collaboration are being proposed to enhance quality outcome tracking and to provide evidence-based international tracking systems to prevent these crises from occurring. The concept of national breast implant registries with global collaboration should be met with enthusiasm. In the United States, there is no effective system of device monitoring or tracking. Records of implanted devices are retained by individual surgeons and manufacturers. Limited tracking has been performed by manufacturers through the Core studies that have been minimally beneficial because they have included only a small number of plastic surgeons and are currently closed for new surgeons. These Core studies are all further limited by low patient accrual, with only several hundred women enrolled. To extrapolate what is occurring in a sample of several hundred patients when hundreds of thousands of breast implants are placed annually in the United States and over 1 million are implanted globally seems inadequate. The establishment of a global registry will permit accrual of thousands of patients within a short timeframe that would be evidence based and less subject to biased interpretation and analysis. Registry oversight should be through a From the Department of Plastic Surgery, Georgetown University. Received for publication September 10, 2014; accepted September 12, 2014. Copyright © 2015 by the American Society of Plastic Surgeons DOI: 10.1097/PRS.0000000000000921
collaborative group of individuals consisting of surgeons, industry representatives, government officials, and insurers. The benefits of a robust registry are that it will establish benchmarks for outcomes both desirable and otherwise. Implanted devices that fail to meet the criteria for safety and efficacy will be identified early, before hundreds of thousands of women are implanted with them. The other aspect of a national registry will be that surgeons will know where they stand in comparison with other surgeons when it comes to reoperations or adverse events. The incidence of adverse events, device failure, and poor outcomes is greater than one would expect. All one needs to do is look at the Core study outcomes to see that reoperation rates and adverse events are higher than we think they should be. Ironically, most of the surgeon participants in the Core studies are the “expert” surgeons that tend to have the best outcomes. I hope that all surgeons participate in the registry and choose not to opt out. Reasons to opt out may include additional paperwork, additional time, possible fees, and the fear that their personal outcomes would be tracked and monitored. Plastic surgeons are becoming increasingly competitive, and to have performance benchmarked and compared with other plastic surgeons may be perceived as a deterrent. I suspect that most patients would be in favor of a national registry and not object to automatic inclusion, because it is being implemented to ensure their safety and the safety of future generations. Spreading the word about these registries should be through the media, the Internet, medical conferences, various women’s organizations, and journals. In essence, the registries would serve as a quality collaborative among all surgeons that will ultimately serve our patients better. The anaplastic large-cell lymphoma issue is another implant-related event that needs to be Disclosure: Dr. Nahabedian is a consultant and speaker for LifeCell, Sientra, and Allergan, but has had no support or direction from these companies in preparing this Discussion.
www.PRSJournal.com
337
Plastic and Reconstructive Surgery • February 2015 monitored closely. Had a globally robust implant registry been established earlier, one could argue that the incidence and trends associated with anaplastic large-cell lymphoma and prosthetic devices would be better understood. Tracking outcomes by means of registries is not a novel concept. In addition to the orthopedic registry, other specialties performing highrisk procedures are adopting mechanisms to track outcomes. A quality collaborative has been adopted by several members of the Americas Hernia Society as a means of improving outcomes. Complex abdominal wall reconstruction has been historically associated with poor outcomes. With this voluntary quality collaborative, outcomes are tracked for all participating surgeons with the ultimate goal of optimizing outcomes for all. In summary, plastic surgery needs accurate, reliable, real-time data that are evidence based and that have not been misinterpreted. National
registries with global collaboration are clearly a first step. Plastic surgery needs to be proactive and not retroactive as is often the case when it comes to a crisis. The silicone gel implant crisis of the 1990s and more recently the Poly Implant Prothèse debacle have demonstrated that an organized and well-managed registry is necessary. Plastic surgeons around the world should embrace the global registry initiative.
FILLER-014 Maurice Y. Nahabedian, M.D. Department of Plastic Surgery Georgetown University 3800 Reservoir Road NW Washington, D.C. 20007 [email protected]
REFERENCE 1. Cooter RD, Barker S, Carroll SM, et al. International importance of robust breast device registries. Plast Reconstr Surg. 2015;135:330–336.
Online CME Collections This partial list of titles in the developing archive of CME article collections is available online at www. PRSJournal.com. These articles are suitable to use as study guides for board certification, to help readers refamiliarize themselves on a particular topic, or to serve as useful reference articles. Articles less than 3 years old can be taken for CME credit. Breast Current Trends in Breast Reduction—David A. Hidalgo et al. Benign Tumors of the Teenage Breast—Mary H. McGrath Breast Reconstruction with Implants and Expanders—Scott L. Spear and Christopher J. Spittler Breast Cancer: Advances in Surgical Management —Alan R. Shons and Charles E. Cox Breast Reconstruction with Free Tissue Transfer—Michael S. Beckenstein and James C. Grotting Recurrent Mammary Hyperplasia: Current Concepts—Rod J. Rohrich et al. Evolution of the Vertical Reduction Mammaplasty—Scott L. Spear and Michael A. Howard Breast Augmentation—Cancer Concerns and Mammography: A Literature Review—Michael G. Jakubietz et al. Breast Augmentation—Scott L. Spear et al.
338
