Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) — is a cancer that has affected a tiny proportion of the women who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer.
Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants
January 2011 Preliminary FDA Findings and Analyses
Reports in the scientific community have suggested a possible association between anaplastic large cell lymphoma (ALCL) and breast implants. In this document we summarize the scientific data the FDA used to assess the possible association. It represents our current understanding, based on the published scientific literature on ALCL in women with breast implants and information gathered through the FDA’s contact with other regulatory authorities, scientific experts, and breast implant manufacturers. The document includes the FDA’s analyses of the data and steps we plan to take to better understand and characterize the possible association.
Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. At this time, data appear to indicate that the incidence of ALCL is very low, even in breast implant patients. Currently it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk.
The FDA is interested in learning more about the actual incidence of ALCL in women with breast implants, the characteristics of breast implants that might increase the risk of ALCL, and the pathological characteristics and clinical features of ALCL in women with breast implants. To this end, FDA is collaborating with the American Society of Plastic Surgeons to establish a registry of cases of women with breast implants who have been diagnosed with ALCL.
Health care providers should be aware ALCL in women with breast implants is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormalities. Current recommendations are described below. As we learn more about ALCL in women with breast implants, these recommendations may change.
- Consider the possibility of 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 ALCL, refer her to an appropriate specialist for evaluation. When testing for ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out 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.
- Report all confirmed cases of ALCL in women with breast implants to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the reporter’s and the patient’s identity confidential.
- Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.
Some researchers have suggested that breast implant-associated ALCL may represent a new clinically entity with less-aggressive (indolent) behavior (Li, 2010; Miranda et al, 2009; Thompson et al, 2010). Because of the small number of cases and the short median duration of follow-up, the FDA believes it is premature to draw conclusions regarding the prognosis of ALCL in women with breast implants.
Because the risk of ALCL appears very small, FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.
- A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’, NYtimes, MAY 14, 2017.
- Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses, FDA, January 2011.
- Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), FDA, Last Updated: 03/23/2017.
- Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), FDA, Last Updated: 03/21/2017.