Breast implant surgery is the No. 1 cosmetic surgical procedure in the U.S. with more than 300,000 breast augmentations performed nationwide last year alone, according to the American Society of Plastic Surgeons. But there is growing concern that breast implants can cause a rare type of cancer.

In 2011, the Food and Drug Administration (FDA) first cautioned the public about the risk of cancer for individuals with breast implants. Five years later, as more reports surfaced, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, as a T-cell lymphoma in people with breast implants.

BIA-ALCL is not breast cancer but a type of non-Hodgkin’s lymphoma that develops sometime after a woman has had breast implant surgery. The disease is usually found in the scar tissue and fluid near the implant, and can spread throughout the body.

In March, the FDA updated the public that it had collected and evaluated additional information about ALCL in individuals with breast implants and had strengthened its understanding of the disease. At the time, the FDA also reported that it had received a total of 414 reports of ALCL in people with breast implants as of Sept. 30, 2017, including nine patient deaths.

Significant limitations in worldwide reporting and a lack of global breast implant sales data has made it difficult for the FDA to determine how many women have developed the disease or the absolute risk a breast implant-user faces. What the data does suggest is that the disease occurs most frequently in people who were implanted with textured-surface breast implants rather than smooth-surface implants. Recent publications have estimated the risk of developing BIA-ALCL in those with textured implants at between 1 in 3,819 and 1 in 30,000.

Of the 414 cases reported, 234 involved implants that were filled with silicone gel, 179 were filled with saline, and one did not specify implant fill type.

Half of the reported cases were diagnosed within seven to eight years of implantation. But, the reports did not indicate whether patients had their original breast implants or if they had one or more replacements.

Individuals with breast implants do not need to change their routine medical care and follow-up. Swelling and pain should be expected immediately after surgery. But patients should contact their doctors if they experience new symptoms or notice changes in the way their breast looks or feels after recovery from surgery. The main symptoms of BIA-ALCL are persistent swelling or pain in the vicinity of the breast implant. This can occur well after the incision has healed, often years after implantation surgery. Some patients reported a lump under the skin or capsular contracture (thick and noticeable scar capsule around the implant).

BIA-ALCL is a frightening diagnosis, and people who have undergone breast augmentation deserve to be told by implant manufacturers of the risks associated with the devices. If you or someone you care about has breast implants and been diagnosed with ALCL, consider contacting a Beasley Allen lawyer for a no-cost, no-obligation consultation.

FDA Safety Communication
American Society of Plastic Surgeons

Melissa Prickett, Beasley Allen Attorney
Melissa Prickett

Melissa serves as the director of operations for Beasley Allen Law Firm’s Mass Torts Section.

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