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Saline and silicone breast implants could be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL), according to a new warning issued by the FDA.
A breast implant medical device safety communication was issued by the FDA on January 26, indicating that there is a possible link between breast implants and the rare form of cancer that usually affects only one in every 500,000 women.
The FDA indicates that it is aware of as many as 60 cases worldwide of ALCL that developed in the breasts of women who received either silicone or saline breast implants. To have ALCL develop in the breast is even rarer, with only three per 100 million women per year diagnosed.
Allergan Inc. and Mentor Corp., a subsidiary of Johnson & Johnson, are the manufacturers of breast implants in the United States. The FDA will require them to update label warnings on their implants to alert doctors and consumers about the reports of ALCL.
The FDA warning said that the agency believes there may be an increased risk for women with breast implants developing ALCL, but that risk is likely low. The agency is still gathering and reviewing information and hopes to have an update this Spring.
With five to 10 million breast implant recipients worldwide, the agency indicates that it cannot conclusively confirm that the implants caused the reported cases of ALCL.
In the 34 cases that have been written up in medical literature, the FDA said that the ALCL was found adjacent to the implant and contained within a fibrous capsule. The patients were usually diagnosed after complaining about implant-related problems like pain, lumps, swelling or asymmetry which occurred after the surgery had healed. The symptoms were caused by masses and fluid surrounding the breast implant, or hardening of the breast around the implant. Examinations of the area around the breasts led to the ALCL diagnoses.
In 27 of the 34 cases that were written up, the women had silicone breast implants and had them for a number of years. However there were cases involving women with saline breast implants as well.
The FDA and the American Society of Plastic Surgeons are setting up a registry for breast implant recipients who have been diagnosed with ALCL in order to get more reliable numbers and better information. The FDA is not recommending that women who have already received breast implants have them removed, nor are they calling for a breast implant recall.
A silicone breast implant recall was issued in 1992 because manufacturers had failed to provide the FDA with necessary medical data showing that the implants were safe and effective. There were concerns at the time of possible breast cancer links, but studies did not find a connection and silicone implants were returned to the market in 2006.
ALCL is not a form of breast cancer, although it can occur in the breasts, the FDA noted. It is a form of lymphoma; which affects cells related to the immune system.
Any women who have breast implants and have been diagnosed with ALCL are asked to call the FDA’s MedWatch program at www.fda.gov/medwatch/index.html.