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Breast Implant Informed Consent Should Include the Risk of Anaplastic Large Cell Lymphoma

Clemens, Mark W. M.D.; Miranda, Roberto N. M.D.; Butler, Charles E. M.D.

Plastic and Reconstructive Surgery: April 2016 - Volume 137 - Issue 4 - p 1117–1122
doi: 10.1097/01.prs.0000481103.45976.b1
Breast: Special Topics
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Summary: Breast implant–associated anaplastic large cell lymphoma (ALCL) is a rare T-cell lymphoma arising around breast implants. Public awareness has increased following a safety communication warning of the association of breast implant–associated ALCL by the U.S. Food and Drug Administration in 2011. Difficulty with determining an accurate assessment of risk, including diagnosis, or standardized treatment regimen has led surgeons to commonly omit preoperative discussion of this rare and frequently misunderstood cancer. Risk disclosure is a form of respect for patient autonomy, and informed consent has positive practical and moral consequences for the practice of plastic surgery. A model of breast implant–associated ALCL informed consent implementation and health care provider education are reviewed with 1-year process follow-up at a tertiary cancer center. Breast implant–associated ALCL should be included during preoperative counseling on the risks of breast implantation when obtaining informed consent. Pertinent aspects of decision-making include disease awareness, presenting symptoms, and resources for concerned patients. Education of health care professionals and provision of patient-focused materials ensures effectiveness of the informed consent process.

Houston, Texas

From the Departments of Plastic Surgery and Hematopathology, The University of Texas M. D. Anderson Cancer Center.

Received for publication September 11, 2015; accepted November 13, 2015.

Disclosure: Dr. Clemens has consulted for Allergan Corporation (Irvine, CA). None of the authors has a financial interest in any of the products or devices mentioned in this article.

A “Hot Topic Video” by Editor-in-Chief Rod J. Rohrich, M.D., accompanies this article. Go to PRSJournal.com and click on “Plastic Surgery Hot Topics” in the “Videos” tab to watch.” On the iPad, tap on the Hot Topics icon.

Mark W. Clemens, M.D., Department of Plastic Surgery, 1400 Pressler Street, Unit 1488, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030., mwclemens@mdanderson.org

Breast implant-associated anaplastic large cell lymphoma (ALCL) is a rare T-cell lymphoma arising around breast implants placed either for reconstructive or cosmetic indications. A safety communication by the U.S. Food and Drug Administration in 2011 cautioning about breast implant–associated ALCL included clinical presentation, prognosis, and treatment options, and subsequently increased public and physician awareness.1 The U.S. Food and Drug Administration confirms that breast implants have a reasonable assurance of safety and efficacy, and the safety communication stemmed from an effort to provide patients and health care providers with the most accurate health-related information on device risk.2 In response to the safety communication, the American Society of Plastic Surgeons developed a collaboration with the U.S. Food and Drug Administration to create the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology Registry, a prospective registry to gather patient information and better characterize breast implant–associated ALCL. The U.S. Food and Drug Administration has asked all health care providers to report confirmed cases. To assist members with patient education, the American Society of Plastic Surgeons added example breast implant–associated ALCL language to downloadable informed consent documents.3 Following recommendations made by the U.S. Food and Drug Administration, implant manufacturers were compelled to add language warning of the existence of breast implant–associated ALCL to the Directions for Use of all breast implant package inserts within the United States and Canada4 (Table 1).

Table 1

Table 1

Risk disclosure is a form of respect for patient autonomy, and informed consent has positive practical and moral consequences for the practice of plastic surgery. Informed consent usually includes both the risk of common adverse events (>1 percent of procedures), and rare but serious adverse events (<1 percent of procedures). Although breast implant–associated ALCL with treatment has demonstrated a good prognosis, the development of a lymphoma is still a rare but serious adverse event for any patient.5–7 Difficulty with determining an accurate assessment of risk, diagnosis, or standardized treatment regimen has led some surgeons to commonly omit preoperative discussion of this rare and frequently misunderstood cancer. The purpose of this article is to review the potential need for breast implant– associated ALCL risk disclosure, discuss the pertinent aspects of informed consent, and review implementation at a major tertiary cancer center with a 1-year follow-up review of the process.

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Need for Informed Consent

Since the U.S. Food and Drug Administration safety communication in 2011, a number of major government agencies around the world have developed breast implant–associated ALCL patient and physician recommendations. The National Comprehensive Cancer Network released statements on breast implant–associated ALCL in 2012, and is expected to issue treatment guidelines in 2016.8 The World Health Organization has officially recognized breast implant–associated ALCL as a subset of ALCL, and its intergovernmental agency, the International Agency for Research on Cancer, in 2014 designated breast implant–associated ALCL a priority of further research to determine the cause of etiology and the mechanism of pathogenesis.9 In 2015, the U.S. National Cancer Institute posted specific surgical recommendations for the treatment of breast implant–associated ALCL.10 In 2015, the French National Cancer Institute (Agence Nationale de Sécurité du Médicament) released diagnosis and treatment recommendations for breast implant–associated ALCL and mandated that all breast implants carry a warning that a clearly established link exists between breast implants and ALCL.11 In addition, to these agencies, nationally standardized breast implant consent forms available in Denmark and Germany have added breast implant–associated ALCL risk. These numerous agencies demonstrate a growing effort to include the risk of breast implant– associated ALCL in discussions about breast implants as an important component of patient education.

The current state of inclusion of breast implant–associated ALCL into informed consent documents used by plastic surgeons is not completely known. An informal poll was performed by the lead author (M.W.C.) of 180 attendees at the 2015 Santa Fe Breast and Body Contouring Symposium. Attendees were asked whether the risk of breast implant–associated ALCL was included in their breast implant informed consent process. Approximately one-third of the attendees acknowledged routinely including a discussion of breast implant–associated ALCL, whereas two-thirds of the attendees conceded no inclusion of risk of the disease. A similar informal poll was performed of 330 attendees at the 2015 London Breast Meeting at the Royal College of Physicians in London, United Kingdom. Approximately one-quarter of the attendees acknowledged routinely including breast implant–associated ALCL language, whereas three-quarters of the attendees did not discuss the risk of breast implant– associated ALCL. Although these two nonscientific polls of approximately 500 plastic surgeons are subject to sampling bias, they suggest that a majority of breast-focused plastic surgeons, both in the United States and the United Kingdom, do not routinely include breast implant–associated ALCL risk for breast implants and that updated informed consent documents have not yet been widely adopted.

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Assessment of Risk

A patient’s ability to sense and appropriately react to risk is directly proportional to his or her understanding of that risk.12 For instance, catastrophic events such as Ebola or terrorist attacks tend to incite much more fear than smoking, alcoholism, or motor vehicle accidents despite the latter examples being proportionately much greater risks to the general public. Breakdown of the informed consent process can occur when insufficient information is given to patients regarding inherent risks.13 Difficulty exists in conveying the exact risk of breast implant–associated ALCL, as the incidence and prevalence are evolving with broader recognition of the disease by the medical community.14 There are an estimated 10 million women worldwide with breast implants, and each year nearly 400,000 implants are placed for cosmetic and reconstructive purposes within the United States.15 Since 1997, approximately 98 breast implant–associated ALCL patients have been reported, published in either case reports or literature reviews. The vast majority of known involved devices have been textured, rather than smooth implants.16 De Jong and colleagues reported an individually matched case-control study from The Netherlands nationwide pathology database. The authors found a positive association for the development of ALCL in women with breast implants compared to those without an implant, with an odds ratio of 18.2 (95 percent confidence interval, 2.1 to 156.8). Based on these data, the authors estimated an incidence of 0.1 to 0.3 per 100,000 breast implant–associated ALCL cases for women with prostheses per year. A number of prior studies failed to show an association between breast augmentation and risk of lymphoma; however, these studies were limited by the number of patients enrolled and an insufficient period of follow-up.17–19 These studies underscore the difficulty of determining the incidence and prevalence of a very rare and recently recognized clinical entity. Given the uncertainty with regard to number of cases, geographic distribution, and susceptible populations, it behooves physicians to involve patients in surgical decisions regarding breast implants and breast implant–associated ALCL.

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Elements of Informed Consent

Effective informed consent should incorporate several critical elements, which include a patient’s capacity and ability to make decisions, disclosure of risks, understanding and comprehension, and finally documentation of surgical authorization.20 A preoperative consultation is ideally a respectful dialogue with patients about their care with sensitivity to the practical limitations and unknowns inherent in medical decision-making. With respect to breast implant–associated ALCL, risk disclosure should have at least three basic objectives, which are each highlighted both in a breast implant package insert (Table 1) and in suggested breast implant–associated ALCL informed consent language (Table 2). The first objective is to make patients aware of the existence of this rare disease. Breast implant–associated ALCL is a rare type of non-Hodgkin lymphoma occurring in the scar tissue and periprosthetic fluid.21 The second objective is for patients to understand common presenting symptoms such as a breast mass or delayed-presentation seroma or effusion. Most patients have been diagnosed when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed on average 8 to 9 years after implantation.22 The final objective is to compel patients to take action and follow up with a physician should these symptoms occur.

Table 2

Table 2

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Institutional Implementation and 1-Year Process Review

A model of breast implant–associated ALCL informed consent implementation and health care provider education was implemented at a tertiary cancer center and the process was reviewed at 1-year follow up. The study period was initiated in August of 2014 with the implementation of breast implant–associated ALCL language added to breast implant informed consent with follow-up evaluation at 1 year in August of 2015. During the study period, breast implant informed consent was administered to patients by 55 health care providers consisting of 18 faculty plastic surgeons, 21 physician assistants, and 16 clinical specialists (microsurgery fellow trainees serving as junior faculty). Before informed consent modification, health care providers received background instruction on breast implant–associated ALCL that included a multidisciplinary breast implant–associated ALCL grand rounds lecture composed of plastic surgery, lymphoma, and hematopathology viewpoints, and disbursement of review articles and an institutional breast implant–associated ALCL frequently asked questions document (now available for download at www.thepsf.org/PROFILE). During the 12-month study period, 3038 new breast cancer patients presented and were treated at our institution. Five hundred fifty-eight women received 940 breast implants, of which all received informed consent, including the risk of breast implant–associated ALCL. At 1 year, health care providers were surveyed on their experience specific to administering breast implant–associated ALCL informed consent. Survey results demonstrated that faculty members and physician assistants were more inclined to report that they were “adequately prepared to discuss the risk of BIA-ALCL with the majority of patients” (100 percent faculty and physician assistant respondents) compared to clinical specialist trainees who were evenly split in also selecting that they “minimally understood BIA-ALCL and at times felt uncomfortable answering questions on the disease” (50 percent clinical specialist respondents). This observed discrepancy in clinical specialist trainee confidence and knowledge level was addressed subsequently with one-on-one educational meetings.

When all health care workers were asked how informed consent was administered, 64 percent of respondents reported that they “usually openly discuss the risk of BIA-ALCL with patients, whereas 36 percent of responders “do not specifically discuss the risk of BIA-ALCL, but allow patients to read the risk of BI-ALCL on the informed consent themselves.” Factors concerning how information is received during informed consent can affect a patient’s ability for later recall and retention of surgical risks and complications.23 Printed copies of a patient’s signed consent and procedure- specific informational pamphlets at an initial consultation will enable patients to further digest surgical details at their leisure in their own homes, and engenders more effective recall.

Fourteen percent of our health care providers reported “rare questions on BIA-ALCL” and 86 percent reported “no specific questions on BIA-ALCL.” Example patient questions were reported as the following: “Are there risk factors for ALCL,” “Is it more common in patients that have had either breast cancer or lymphoma,” “How did patients do that developed ALCL,” and “Would insurance cover screening if I think I may have ALCL?” Notably, all health care providers reported consensus that no patients changed their operative plan when informed of the risk of breast implant–associated ALCL. Ultimately, health care providers felt all patients were adequately aware of implant risks, including breast implant–associated ALCL, and were able to give reasonable informed consent. This survey was performed at a high-volume breast reconstruction cancer center, and the responses suggest that breast implant–associated ALCL modification of the informed consent was well received, not disruptive to patient interactions, and in some rare cases stimulated needed discussions that aided patient decision-making.

Although breast implant–associated ALCL is exceedingly rare, 11 patients diagnosed and treated for breast implant–associated ALCL were immediately available to interview for this article. All patients reported that they had received informed consent at the time of original implantation but that the risk of breast implant–associated ALCL was not included in any case. This is not surprising, as all of the women underwent implantation before the 2011 U.S. Food and Drug Administration safety communication with operative dates ranging from 1998 until 2007. All patients noted that the first time they were informed of breast implant–associated ALCL was at their respective diagnoses. As expected, all of the affected women were in agreement that breast implant–associated ALCL risk should be included for implant informed consent. In three cases, symptomatic breast implant–associated ALCL patients had postponed assessment by a physician because they were not aware that unexplained unilateral swelling of the breast mandated evaluation.

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Medicolegal Implications

Surgeons are assumed to disclose “material” risks of surgery to a patient, defined as “the information patients need to make a medical decision.”24 The legal threshold for inclusion of a specific risk in informed consent is unfortunately vague, and therefore the decision to include breast implant–associated ALCL in informed consent should ideally be by self-obligation, not mandate. Despite the realities of a litigious society, it is important to remember that informed consent is a process, not an event; and an ongoing conversation to be had, not a form to be signed. Liability more frequently results from a lack of communication, and surgeons are most commonly judged not by their mistakes but by how they have managed them.

The future of insurance coverage of complications related to breast implants continues to evolve and is not guaranteed. An analogy has been raised with regard to screening for breast implant ruptures. When the U.S. moratorium on silicone implants ended in 2006, the U.S. Food and Drug Administration recommended that all women with silicone breast implants undergo magnetic resonance imaging evaluation for implant failure at 3 years after implantation. Because insurance policies do not cover this screening, the suggested study is not widely performed.25 Fortunately, a similar trend has not been seen with regard to screening for breast implant–associated ALCL. Whereas magnetic resonance imaging screening is for device failure, patients with delayed seromas are being screened for the presence of a malignant lesion of the breast. Therefore, physicians should not hesitate to perform pathologic review of an effusion, importantly, with CD30 immunohistochemistry (which is not performed on routine specimen evaluation) if they have a reasonable clinical suspicion of a cancer. Pertinent International Classification of Diseases, 10th Revision and Current Procedural Terminology codes related to diagnosis and treatment of breast implant– associated ALCL are listed in Table 3.

Table 3

Table 3

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SUMMARY

First, informed consent should be provided to any patient with breast implants for either reconstructive or aesthetic indications. Second, breast implant–associated ALCL informed consent is ideally implemented following topic review by the health care professional. A reality of this discussion is that patients may have unresolvable questions, significant knowledge gaps still exist, but up to date resources from the U.S. Food and Drug Administration and our national societies are available for further review. Third, patients should be aware of the existence of breast implant–associated ALCL, common presenting symptoms such as a mass or delayed-presentation seroma/effusion, and to follow up with a physician if they occur. Fourth, pertinent aspects of decision-making include the provision of patient-focused materials, which ensures effectiveness of the informed consent process. Finally, the significance of this study is the confirmation that patients can understand disclosure about a very rare disease, and can use albeit limited information to formulate surgical preferences and more importantly to have awareness of suspicious symptoms.

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ACKNOWLEDGMENT

Data analyses were supported in part by a Cancer Center Support Grant (National Cancer Institute grant P30 CA016672).

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REFERENCES

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