FDA - Breast Implants Linked to Development of Anaplastic Lymphoma
by Dr. C.H. Weaver M.D. 2/2019
The US Food and Drug Administration (FDA) is concerned that women with breast implants have an increased risk of developing anaplastic large cell lymphoma. More cases of this rare T-cell lymphoma associated with breast implants have been recently reported, and the FDA has issued an alert to health care providers.
The number of lymphoma cases linked to breast implants increased in the second half of 2019, according to the FDA. The agency identified 733 unique cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) worldwide. Almost 85% of confirmed BIA-ALCL cases reported to the FDA involved implants made by Allergan. In response to a request from the FDA, Allergan recalled specific models of its textured implants due to a potential risk for BIA-ALC an, the FDA issued draft guidance recommending inclusion of a boxed warning on breast implant labeling to ensure women receive and understand complete information about their benefits and potential risks.
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Over time, a fibrous scar called a capsule develops around an implant which separates it from the rest of the breast. In patients with breast implants the lymphoma is generally found adjacent to the implant itself and contained within the fibrous capsule.
Symptoms of the anaplastic lymphoma typically include swelling and redness around the breast implants. The average time between implantation and the development of the lymphoma is 9.2 years.
About 10 million to 11 million women in the world have breast implants, according to the American Society of Plastic Surgeons and the Plastic Surgeon Foundation so the condition is quite rare but needs to be looked for and detected early.
According to the FDA most of the lymphomas occurred in people who had textured surfaces on their implants, rather than smooth surfaces. The illness is slow-growing and treatable when it's detected early. Routine breast screening however is probably the best way to monitor for the changes with mammograms or MRIs.
People who are considering getting implants should do their research and discuss with their surgeons the risks and benefits of textured- and smooth-surfaced implants, the FDA has warned in the past.