Source: US Food & Drug Administration
Another “Oops!” from the US FDA. Scientists from the US Government Agency have reached that conclusion after examining scientific literature on cases of ALCL in 34 women with breast implants, as well as information from agency reports, international regulatory agencies, scientific experts, and breast implant manufacturers themselves.
The official statement reads: “After an intensive review of known cases of a rare form of cancer in breast implant recipients, the Food and Drug Administration says women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.”
But with an estimated five to 10 million breast implant recipients worldwide, agency experts say the known ALCL cases are too few to say conclusively that breast implants cause the disease. FDA believes there are about 60 of these ALCL cases worldwide, though that number is difficult to verify because not all of them were chronicled in scientific publications and some reports may have been duplicated.
Dr. Binita Ashar, a physician and FDA scientist evaluating ALCL cases provides the following information for women with implants:
Q: What does FDA want women to know about breast implants and ALCL?
A: Although the risk is quite small, we want women to be aware that there have been reports of ALCL occurring around saline and silicone gel-filled breast implants. In the cases reported, ALCL was typically diagnosed years after the implant surgery. In most of these cases, the women were diagnosed after they observed changes in the look or feel of the area surrounding the implant.
Q: What advice is FDA giving to women?
A: If a woman with breast implants has no symptoms, FDA does not recommend doing anything additional. Women should continue monitoring their implants and obtaining regular breast screening evaluations. The FDA does not recommend removing the implants. (Yes, that would be silly).
Women who see changes in the way the area around the implant looks or feels—including swelling or pain around the implant—should see a physician for evaluation. Women considering breast implants should be aware of the very small, but increased risk of developing ALCL and discuss it with a physician.
Q: How long will it be until FDA has more information to share?
A: Depending upon the number of reports the registry receives, we may have information that we can share soon. If we receive only a few reports, it may take some time to get the information we’re looking for—such as whether this is a new type of ALCL and if the type of implant has an impact on ALCL development
If you want to learn more about breast implants and ALCL, visit the FDA’s Center for Devices and Radiological Health.
If you have breast implants and have been diagnosed with ALCL, submit an online report through the agency’s MedWatch program online8 or call 1-800-332-1088. All reports are confidential.
Post: David M. Schwadron, Esquire