The FDA has identified that breast implants may be associated with a rare form of cancer called anaplastic large-cell lymphoma, believed to be associated with chronic bacterial inflammation.[69] Similar ALCL phenomena have been seen with other types of medical implants including vascular access ports, orthopedic hip implants, and jaw (TMJ) implants. As of February 1, 2017, the FDA has received a total of 359 medical device reports of breast-implant-associated ALCL (BIALCL), including 9 deaths.[70] Most cases of breast implant-associated ALCL had implants in for many years prior to the condition, and are usually treated successfully by simple removal of the implant and the capsule surrounding the implant without the need for chemotherapy if no evidence of systemic disease exists. If women with implants present with delayed swelling or fluid collection, cytologic studies and test for a marker "CD30" are suggested. The American Society of Plastic Surgery (ASPS) states, "CD30 is the main diagnostic test that must be performed on the seroma fluid as routine pathology or H&E staining can frequently miss the diagnosis." [71] Diagnosis and treatment of breast implant associated ALCL now follows standardized guidelines established by the National Comprehensive Cancer Network.[72]
Silicone-filled Breast Implants. Silicone-filled breast implants are filled with a silicone gel. Over the years, the consistency of this silicone filling has changed. The first silicone breast implants were filled with a very thin, oily silicone. Currently, the silicone used in implants is a gel that is less likely to leak out of the shell if it ruptures. This gel is referred to as "cohesive." Some breast implants — called gummy bear breast implants — are even more cohesive, or "form-stable," and have the consistency of a gummy bear, thus the nickname.
Both saline-filled breast implants and silicone-filled implants have an outer shell composed of silicone elastomer. This shell is basically a flexible envelope that contains the implant filling. In the case of some anatomically shaped implants, the shell also gives the implants shape. Some models of implants have a "double lumen." This is an elastomer envelope inside of another elastomer envelope (sort of like double-bagging your groceries) which may reduce the risk of implant rupture.

The current lifetime risk of BIA-ALCL in the U.S. is unknown, but estimates have ranged between estimated to be between 1 in 70,000 to 1 in 500,000 women with breast implants according to MD Anderson.[73] Certain geographic locations have demonstrated variable risks. For instance, a December 2016 update from the Therapeutic Goods Administration of Australia and New Zealand reported a risk of 1:1,000 to 1:10,000 for textured implants.".[71] To date (2017), there has not been a case of BIAL reported where the patient had only implantation of smooth shell breast implants or a textured tissue expander that was exchanged for a smooth implant. The paucity of cases reported in Asian populations has raised the possibility that there may be a range of genetic susceptibility to the phenomena, or alternatively merely reflect differences in how cases are identified and reported.
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