News and Commentary

FDA Warns: Nine Women Have Died Of Lymphoma That’s Linked To Breast Implants

On Wednesday, the U.S. Food and Drug Administration’s Dr .Binita Ashar Federal Drug Administration released a statement on the danger of women getting cancer after having breast implants. As CNN reported, “At least 457 women in the United States have so far been diagnosed with anaplastic large cell lymphoma. … Of those, nine have died as a result of the rare cancer, which affects cells in the immune system and can be found around the breast implant.” Anaplastic large cell lymphoma is a type of non-Hodgkin’s lymphoma.

The American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons has written: “BIA-ALCL usually develops as a delayed swelling of the breast (Average 8 years, range 2 to 28 years) after the insertion of textured breast implants, which may present as fluid collecting around the implant or marked breast asymmetry. It can also present as a lump in the breast or armpit.”

The FDA statement said, “We recognize the limitations of medical device reports, which is why we review other sources of information, including medical literature and the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology. PROFILE collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. Our participation in this registry reflects the FDA’s commitment to implementing our Medical Device Safety Action Plan, in which we are streamlining and modernizing how we implement postmarket actions to address device safety issues to make our responses to risks more timely and effective.”

In addition to the statement, the FDA also issued a letter warning professionals in the medical field about the connection between the implants and the cancer. It stated:

We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy. We are also asking health care providers to report to the FDA cases of BIA-ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice. BIA-ALCL is a type of lymphoma and is not a cancer of the breast tissue. When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In patients with breast implants, reported cases of BIA-ALCL were generally found adjacent to the implant itself and contained within the fibrous capsule.

The Daily Mail notes, “The amount of women diagnosed with BIA-ALCL – which kills cells in the immune system and normally begins with pain and swelling in the breast – shot up from 414 cases in the last 12 months and 359 the year before that … The majority of ALCL cases have been linked to textured breast implants as opposed to smooth implants. Smooth implants are softer than their textured counterparts, allowing for a more natural look and feel – but may lead to slightly visible rippling and shifting in position over time. Textured breast implants tend to stick to the body’s tissue, helping them stay in the same position over time.”