Study Sees Link between Breast Implants, Rare Immune System Cancer

A new study has confirmed a link between <"">breast implants and anaplastic large cell lymphoma or ALCL. However, a panel that reviewed the research found that it does not yet prove that breast implants cause ALCL, or suggest what mechanism might lead to the development of the cancer.

ALCL is a rare immune system cancer (non-Hodgkin’s lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver. Concerns about a possible link between breast implants and ALCL were first raised in 1996, following publication of a report describing a woman with implants who had developed the cancer in tissue located next to one of her implants. Since then similar reports have been published, and it is estimated that one in three women with breast implants – silicone or saline – will develop ALCL.

Earlier this year, the U.S. Food & Drug Administration (FDA) warned that 60 cases of ALCL have been reported in breast implant patients. The agency also said its review of the medical literature published between January 1997 and May 2010 revealed 34 unique cases of ALCL. Twenty-seven cases of the lymphoma involved silicone breast implants, while most were diagnosed after silicone implants returned to the market in 2006.

This latest study was conducted by the non-profit RAND Corporation and commissioned by the Plastic Surgery Foundation, together with the Aesthetic Surgery Education and Research Foundation. The RAND review of medical literature identified 36 published cases of non-Hodgkin’s lymphoma among women with breast implants, 29 of which were diagnosed as ALCL. At least 12 of the 29 women had a prior history of a different type of cancer, including eight who had undergone mastectomy for breast cancer and two who had a previous history of ALCL. There was no evidence that patient risk factors or particular types of implants would increase the risk of the disease, according to the study.

For most women, treatment consisted of surgically removing the affected implant and surrounding tissue, which appeared to successfully control the disease. Others, however, did undergo chemotherapy and radiation. No deaths were reported among the 16 women for whom follow-up information was available.

The RAND researchers shared the review findings with a medical panel that included experts from many disciplines, including epidemiology, oncology, immunology, pathology, and material science. The panel concluded that the evidence suggests an association between breast implants and ALCL, but cannot definitely prove that implants cause the disease nor explain how the implants might trigger ALCL.

The panel recommended that breast implant patients undergo a thorough diagnostic screening for ALCL if a fluid-filled sac appears near a breast implant six or more months after surgery. An ALCL diagnosis should trigger a thorough evaluation to determine if the cancer has spread outside the breast capsule.

“Much more research is still needed to explore the link between breast implants and ALCL and the clinical significance of this rare disease, but our findings provide useful information for both patients and physicians in the near term,” said Dr. Soeren Mattke, the study’s senior author and a senior scientist at RAND, in a statement announcing the study’s findings.

This entry was posted in Breast Implants, Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.