| More Information on Association Between Anaplastic Large Cell Lymphoma (ALCL) and Breast Implants |
More information is available on the link between Anaplastic Large Cell Lymphoma (ALCL) and breast implants. As noted in an earlier blog post, the U.S. Food and Drug Administration announced last week the
link between ALCL and breast implants.
It is important to note that ALCL is not breast cancer. ALCL is a type of lymphoma, a cancer of the cells of the immune system. In the cases where women with breast implants developed ALCL, ALCL was not found in the breast tissue itself, but in the fibrous scar capsule surrounding the implant. Over time, a fibrous scar tissue called a capsule develops around a breast implant, separating the implant from the rest of the breast. The ALCL is found within this fibrous capsule.
ALCL has been diagnosed most frequently in women undergoing implant revision operations for late onset, persistent seroma (collection of fluid). Most patients are diagnosed when they seek medical treatment for implant related symptoms such as pain, lumps, swelling, or asymmetry that developed long after their initial surgical sites were fully healed. These symptoms were due to persistent seroma, hardening of breast area around the implant (capsular contraction), or masses surrounding the breast implant.
Importantly, the FDA is NOT recommending prophylactic breast implant removal in patients without symptoms or other abnormalities. However, the risk of ALCL should be considered by any woman considering whether to undergo breast implant surgery.
The FDA is requesting that healthcare professionals and patients report any confirmed cases of ALCL in women with breast implants. You may report a confirmed case to the FDA online HERE.
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| Anaplastic Large Cell Lymphoma (ALCL) Linked to Breast Implants |
The U.S. Food and Drug Administration announced yesterday a possible association between saline and silicone gel-filled breast implants, and anaplastic large cell lymphoma (ALCL). Data suggests that patients with breast implants have a very small, but significant, risk of ALCL in the scar capsule adjacent to the implant.
ALCL is a relatively uncommon type of non-Hodgkin’s lymphoma that arises from T-cells. ALCL is diagnosed in about 1 out of 500,000 women in the United States each year. ALCL located in breast tissue is even less common. The FDA is aware of only about 60 cases of ALCL worldwide in women with breast implants. However, the exact number is uncertain because it is likely that not all cases have been reported.
At present, breast implant manufacturers do not warn of the risk of ALCL. However, in an effort to ensure that patients receiving breast implants are informed of this risk, the FDA will be working with manufacturers in the coming months to update their product labeling materials to add a warning.
The FDA is requesting that healthcare professionals and patients report any confirmed cases of ALCL in women with breast implants. You may report a confirmed case to the FDA online HERE
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