On January 26, 2011, the U.S. Food and Drug Administration announced a potential association between saline-filled and silicone gel–filled breast implants and anaplastic large cell lymphoma (ALCL), a rare type of cancer. According to the U.S. Food and Drug Administration press release, data reviewed by the U.S. Food and Drug Administration suggested that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.1 Through a review of the scientific literature published between January of 1997 and May of 2010, 34 unique cases of ALCL in women with both saline and silicone breast implants have been identified among up to 10 million women with breast implants. Using additional information obtained from other international regulators, scientists, and breast implant manufacturers, the U.S. Food and Drug Administration is aware of up to a total of 60 potential cases, although confirmation is pending. The full report of the preliminary findings summarized the key findings as follows2:
- There is a possible association between breast implants and ALCL. Based on the published case studies and epidemiologic data, the incidence of ALCL appears to be very low, but the occurrence of ALCL in patients with breast implants may not be a coincidence.
- It is not possible to identify a specific type of implant associated with a lower or higher risk of ALCL at this time.
- The true cause of ALCL in women with breast implants is not certain.
In response to this information, the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery immediately issued news releases, providing a number of resources for their members and for patients. Highlights of the American Society of Plastic Surgeons/American Society for Aesthetic Plastic Surgery responses were as follows3,4:
- The American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery are working in full cooperation with the U.S. Food and Drug Administration on this important development.
- ALCL is extremely rare—of the estimated 10 million breast implants worldwide, only 34 cases have been published since 1989.
- The U.S. Food and Drug Administration estimates that the potential risk of women with breast implants developing ALCL is extremely low.
- Both the U.S. Food and Drug Administration and the plastic surgery societies are confident that breast implants remain safe and effective.
- Numerous links to additional resources were provided.
On the same day, the American Society of Plastic Surgeons announced the establishment of a collaboration with the U.S. Food and Drug Administration on the creation of a breast implant registry.5
THE NEED FOR SCIENTIFIC DATA ON ALCL AND BREAST IMPLANTS
The U.S. Food and Drug Administration release has brought into focus a condition that previously had been noted primarily through scattered case reports. Plastic and Reconstructive Surgery, along with the American Society of Plastic Surgeons, the American Society for Aesthetic Plastic Surgery, and the U.S. Food and Drug Administration, takes seriously any potential yet remote possible connection between breast implants and ALCL, and we are responding to the situation by providing the best peer-reviewed scientific data available on the subject as quickly as possible. At this time, there is no established causal relationship between breast implants and ALCL. With that said, it is crucial that we determine an accurate and methodologically and scientifically sound evaluation of this potential relationship. The entire plastic surgery community is rising to the challenge of undertaking a deep, evidence-based assessment of this condition and to uncovering the scientific facts necessary for the best education of surgeons and optimal care of patients. This edition of Plastic and Reconstructive Surgery contains the first of a series of articles addressing the ALCL topic.
To date, the societies, along with their journals, have proactively taken several steps to gather additional information on ALCL and make it available to the membership. In addition to providing resource links and information in 2010, the societies commissioned, through the Plastic Surgery Foundation and the Aesthetic Surgery Education and Research Foundation, the RAND Corporation to complete an independent review and assessment of ALCL and breast implants. Published in this issue of Plastic and Reconstructive Surgery is the first of two resultant articles authored by RAND Corporation scientists and plastic surgeons entitled “Anaplastic Large Cell Lymphoma and Breast Implants: A Systematic Review.”6 The purpose of this study was to identify and analyze all reported cases of non-Hodgkin's lymphoma occurring in patients with breast implants. The authors conducted a systematic literature review of reported cases of non-Hodgkin's lymphoma in patients with breast implants. After an exhaustive literature review, only 36 cases of non-Hodgkin's lymphoma in patients with implants were found, of which 29 (86 percent) were ALCLs. The study concludes that a form of ALCL may be associated with breast implants, and urges that additional research continue to better determine the epidemiology and biology of ALCL. Also in this issue is a Viewpoint article by Lazzeri et al.7 that describes a case of ALCL arising in a silicone breast implant capsule and reviews the literature in relationship to this presentation.
Additional articles will be published in the July 2011 issue of Plastic and Reconstructive Surgery, including a consensus panel recommendation and review of the literature on managing late periprosthetic fluid collections in patients with breast implants8 and an updated algorithm on the diagnosis and management of seroma following breast augmentation.9 These articles and their associated discussions are particularly germane as the most common presentation of ALCL in the presence of breast implants is a late periprosthetic seroma.
Additional studies will follow soon thereafter, including the first published report of a patient death attributable to implant-related ALCL.10 While some authors have suggested that ALCL associated with breast implants may have a less aggressive course than systemic ALCL, this article raises important questions about potentially varied presentations of ALCL in the presence of breast implants. A systematic review of the literature on anaplastic large T-cell lymphoma and breast implants11 and the results from a structured expert consultation process on ALCL and breast implants,12 the second of the articles from the RAND assessment, are also soon to follow.
In order to expedite the dissemination of information, Plastic and Reconstructive Surgery will place newly accepted articles relevant to ALCL and breast implants on the Advance Online (publish ahead-of-print) section of the PRSJournal. com Web site. The Journal is also creating an online article collection of all ALCL-related materials available at PRSJournal.com. As new articles are published in the regular print editions, they will be posted to the collection for easy reference.
We anticipate that these articles will be just the first in a series of carefully conducted, peer-reviewed studies published in future issues of Plastic and Reconstructive Surgery. We issue the call to plastic and reconstructive surgeons, basic scientists, and epidemiologists to conduct the highest level of scientific research that will generate evidence-based medicine articles on this important topic. We are confident that if a connection exists between breast implants and ALCL, we will find it and will determine the best course of action in the future for our patients. After all, plastic surgeons as physicians place patient care and safety first and foremost.
6.Kim B, Roth C, Chung KC, et al. Anaplastic large cell lymphoma and breast implants: A systematic review. Plast Reconstr Surg.
7.Lazzeri D, Agostini T, Giannotti G, et al. Null-type anaplastic lymphoma kinase–negative anaplastic large cell lymphoma arising in a silicone breast implant case. Plast Reconstr Surg.
8.Bengston B, Brody GS, Brown HM, et al. Managing late periprosthetic fluid collections (seroma) in patients with breast implants: A consensus panel recommendation and review of the literature. Plast Reconstr Surg.
9.Tebbetts JT. Diagnosis and management of seroma following breast augmentation: An update. Plast Reconstr Surg.
10.Carty MJ, Pribaz JJ, Antin JH, et al. Patient death attributable to implant-related primary anaplastic large cell lymphoma of the breast: A case report and review of the literature. Plast Reconstr Surg.
11.Hammond DC, Jewell M, Spear SL, Largent J, Oefelein MG, Adams WP Jr. Anaplastic large T-cell lymphoma and breast implants: A systematic review of the literature. Plast Reconstr Surg.
12.Kim B, Roth C, Young VL, et al. Anaplastic large cell lymphoma and breast implants: Results from a structured expert consultation process. Plast Reconstr Surg.