A least nine deaths have been linked to a rare blood cancer associated with breast implants, the Food and Drug Administration (FDA) announced Tuesday.
The recommendation followed an update of the agency's database and understanding of BIA-ALCL and brought the FDA into "concurrence with the World Health Organization (WHO) designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants". ALCL appears to be more common in women whose implants have a textured-rather than smooth-surface, according to Medscape.
While saline implants contain sterile salt water and can be inserted empty (to be infused during cosmetic surgery), silicone implants are pre-filled with silicone gel, whose texture closely resembles natural tissue.
Doctors and researchers have been investigating a connection between breast implants and ALCL * a href="https://www.ncbi.nlm.nih.gov/pubmed/?term=breast+AND+(implant*+OR+prosthesis+OR+prosthes*+OR+endoprosthes*)+AND+lymphoma*" *for years. But it's easily treated if caught early, which typically happens when women start suffering pain and swelling. But the current data suggests the rare form of cancer occurs more frequently with textured-surface breast implants versus those with smooth surfaces. However, usually when the lymphoma pops up, simply removing the implant and surrounding tissue eliminates the disease, though some women may need chemotherapy and radiation, as well.
In the United States, approximately 290,000 women underwent surgery for breast enlargement in 2016.
As of February 1, the FDA said it "has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths".
New information about BIA-ALCL came from medical device reports (MDRs), current medical literature, data from a patient registry established by the American Society of Plastic Surgeons and the Plastic Surgery Foundation (PSF), and product and labeling information provided by implant manufacturers. Of those, 28 of the cancers were in women who received breast implants with smooth surfaces and 203 were in women who had a version with a textured surface.
The FDA has a breast implants website with more details.
When did the FDA first discover the link?
. The FDA will keep the identities of the reporter and the patient confidential. The FDA also reccomends women get a "routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants". If you notice any changes, contact your health care provider promptly to schedule an appointment. "Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants".
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