Rare Lymphoma Reported in Breast Implant PatientsFeb 3, 2011 | Parker Waichman LLP
Breast implants, long touted as safe medical devices, are now being linked with a rare type of lymphoma. According to an alert from the Food & Drug Administration (FDA), its recent review of the medical literature identified 34 unique cases of anaplastic large cell lymphoma (ALCL) in women with either saline or silicone breast implants. In total, 60 such cases of the cancer were identified in breast implant patients.
The FDA is requiring the two makers of breast implants, Allergan and Mentor Worldwide, to continue safety studies, including one with more than 40,000 patients. The American Society of Plastic Surgeons also announced that it is establishing a national registry for breast implants in collaboration with the FDA to monitor safety issue
ALCL is a rare malignant tumor (non-Hodgkin lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.
Twenty-seven cases of ALCL identified by the FDA involved silicone breast implants. Most of the ALCL cases were diagnosed after silicone implants returned to the market in 2006. The diagnoses tended to occur a median of eight years after implantation, and involved implants for breast augmentation as opposed to reconstruction following breast cancer surgery.
Signs of ALCL in breast implant patients include pain, lumps, swelling, or asymmetry that developed after patients’ initial surgical sites were fully healed. The FDA is recommending that health care professionals and women pay close attention to breast implants. Breast implant recipients should contact their doctor if they notice any changes.
The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.