After reviewing the medical data, the U.S. Food and Drug Administration concluded that TDA-induced breast cancer was an infinitesimal health-risk to women with breast implants, and did not justify legally requiring physicians to explain the matter to their patients. In the event, polyurethane-coated breast implants remain in plastic surgery practice in Europe and in South America; and no manufacturer has sought FDA approval for medical sales of such breast implants in the U.S.[93]
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]
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