Anna E. Mazzucco. “Next steps for breast implant–associated anaplastic large-cell lymphoma.” Journal of Clinical Oncology: June 16, 2014
To the Editor:
The excellent analysis by Miranda et al1 based on extended follow-up of patients with breast implant-associated anaplastic large-cell lymphoma (ALCL) adds to the mounting evidence of the potential for aggressive clinical behavior of this disease.2,3For the first time, these researchers identified two patient subpopulations with distinct clinical outcomes: 75% of the patients with solid ALCL tumors had survived at 5 years postdiagnosis, compared with 100% of patients with effusion-type ALCL. In contrast, earlier studies suggested that breast implant–associated ALCL was likely to be clinically indolent and more similar to primary cutaneous, anaplastic lymphoma kinase (ALK) –negative ALCL, rather than the more aggressive systemic form of the disease.4,5
Although ALCL is rare, breast implants increase the risk by an estimated odds ratio of 18.2.6,7 Miranda et al1 found aggressive ALCL and potential mortalities associated with either saline or silicone-filled implants in both cosmetic and reconstruction patients, and point out that the lack of routine pathology examination of seroma or excised tissue could result in an underestimation of ALCL occurrence. Extrapolating from their findings, the lack of routine pathology is likely to delay the diagnosis when women with implants seek medical care from plastic surgeons or primary care physicians for swollen breasts that are assumed to be infected.
Timely diagnosis will depend on the millions of women with breast implants having access to heightened surveillance, knowledgeable physicians, and appropriate testing and medical care. All of the ALCL cases described in Miranda et al1 were ALK negative, which has a poor overall prognosis and is treated with cytotoxic chemotherapy.8 Others have proposed that all seromas associated with implants, especially those which are therapy resistant, should therefore be carefully monitored, and any patient presenting with recurrent seroma 6 months or more after implantation should undergo aspirate analysis without delay.9,10 The question is, how can such monitoring be ensured?
The track record for monitoring the health of patients with breast implants is not encouraging, however. For example, the US Food and Drug Administration recommends that all women with silicone gel breast implants undergo regular magnetic resonance imaging scans starting 3 years after implantation to check for implant rupture, but most insurance policies do not cover such screening; therefore, few women follow these guidelines. Moreover, many health insurance policies currently exclude any services related to complications from cosmetic surgery; this excludes the approximately 75% of women whose breast implants were originally for cosmetic purposes rather than reconstruction after mastectomy. Our research center’s recent review of health care policies under the Affordable Care Act found no evidence that the growing literature on breast implant–associated ALCL has influenced health insurance coverage for either cytology cultures of seroma or removal of breast implants and capsules that are causing ALCL.
Future studies are needed to elucidate what factors determine whether specific types of breast implants are more likely to increase the risk of ALCL, particularly solid tumors. The collaboration between the US Food and Drug Administration and the American Society of Plastic Surgeons to create a registry of implant recipients who develop ALCL should provide useful information. As new data become available, they should quickly be used to improve early diagnosis and treatment. That will require insurance coverage of medically necessary services for women with serious breast implant complications, including those with implants originally for cosmetic purposes.
Read the original article here.
- Miranda RN, Aladily TN, Prince HM, et al. (2014) Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol32:114–120.
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- US Food and Drug Administration. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses, 2011.http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239996.htm.
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- Taylor KO, Webster HR, Prince HM