Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
The US Food and Drug Administration (FDA) is reporting that individuals with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. Precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide.
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL). At that time, the FDA knew of so few cases of ALCL that it was not possible to determine what factors increased a patient’s risk. In a report summarizing the Agency's findings, the FDA emphasized the need to gather additional information to better characterize ALCL in individuals (cis- and trans-gender women and men) with breast implants. Over time, the FDA has strengthened thier understanding of this condition:
- In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants.
- The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data.
- At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.
In their announcement, the FDA reports that as of September 30, 2017, the FDA had received a total of 414 medical device reports (MDRs) of BIA-ALCL, including the death of nine patients. The FDA announcement also includes a summary of FDA actions to date, current status, medical device reports, a summary of medical literature and recommendations for patients and health care providers which include but are not limited to:
- Provide all patients with the breast implant manufacturer’s labeling as well as other educational material prior to implantation, and make sure they are aware of the benefits and risks of the different types of implants. Most confirmed cases of BIA-ALCL have occurred in women with textured surface implants.
- Consider the possibility of BIA-ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the individual’s case to a multidisciplinary tumor board for evaluation.
- When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.
- Develop an individualized treatment plan in coordination with the patient's multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
- Report all confirmed cases of ALCL in individuals with breast implants to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
- Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.
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