The Food and Drug Administration (FDA) is investigating a possible link between saline and silicone breast implants and a very rare type of cancer called anaplastic large cell lymphoma (ALCL). For now, the FDA is advising doctors and patients to monitor breast implants and report any cases of ALCL.
On Wednesday, the FDA said it had reviewed the scientific literature on ALCL in women with breast implants published between January 1997 and May 2010, as well as reports from international regulators, scientists and breast implant manufacturers. The scientific literature identified 34 unique cases of ALCL in women with both saline and silicone breast implants. (More on Time.com: Another Use for Breasts: Medical Experiments)
According to the FDA statement:
Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid, hardening of breast area around the implant, or masses surrounding the breast implant.
In most cases, cancer cells were found in the so-called effusion fluid or fibrous capsule surrounding the implant (see diagram, above). Of the 34 cases, the median time between the placement of a breast implant and ALCL diagnosis was 8 years, with a range from 1 year to 23 years. (More on Time.com: For Childhood Cancer Survivors, the Many Benefits of Breast-Feeding)
Based on the available evidence, the FDA said it was not possible to say definitively that breast implants cause ALCL, especially because the cancer is so rare, even in implant patients. Nevertheless, according the FDA’s preliminary analysis of data:
[D]espite the low total number of reported cases, certain factors suggest the occurrence of ALCL in patients with breast implants may not be coincidence. If ALCL in women with breast implants were due only to chance, one would expect for it to occur with similar frequency in all parts of the breast. Instead, ALCL is usually located in the region immediately surrounding the breast implant.
According to the National Cancer Institute, ALCL, which may appear in different parts of the body including the lymph nodes and skin, is diagnosed in about 1 of 500,000 women in the U.S. In women without breast implants, ALCL located in breast tissue is found in about 3 of 100 million women. In total, the FDA said it is aware of 60 cases of ALCL in women with breast implants worldwide, but that number is difficult to verify because some may be duplicate reports. (More on Time.com: Even Small Amounts of Drinking Boost Cancer Risk)
An estimated 5 million to 10 million people worldwide have breast implants.
The FDA does not recommend that patients remove their implants. Rather, doctors and implant recipients should continue regular breast exams and be vigilant about any changes to the feeling, shape or appearance of the site around their implants. Any cases of ALCL should be reported to the FDA’s MedWatch.