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Federal health regulators are warning that at least nine people have died from a rare form of cancer that may be linked to certain breast implants, known as anaplastic large cell lymphoma (ALCL).
In a statement issued on Tuesday, the FDA indicates that it has received at least 359 medical device reports involving breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a form of non-Hodgkin’s lymphoma. The reports include information on at least nine deaths linked to the rare form of cancer.
The FDA indicates that it agrees with a designation by the World Health Organization (WHO), which has determined that breast implants are associated with the rare form of T-cell lymphoma. However, the agency is still reviewing the risks and seeking more information.
“The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data,” the FDA warning notes. “At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.”
The FDA first issued a breast implant ALCL safety communication in January 2011, indicating that the agency was aware of at least 60 cases worldwide at the time, and that the phenomenon appeared to be linked to both saline and silicone breast implants. However, as of February 1, the FDA notes it has received 359 medical device reports of BIA-ALCL, including nine deaths. The FDA received data on the breast implant surface in 231 of the reports, and 203 of those involved the use of implants with textured surfaces, while only 28 of those cases were linked to implants with smooth surfaces.
Due to the potential lymphoma risk with breast implants, the agency is recommending that health care providers be aware that cases of the rare cancer have been linked to textured breast implants, and that they should discuss the benefits and side effects of the implants with their patients. The agency also recommends that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.
Patients are advised to be aware of the cancer risk, talk to their doctors about the risks and benefits of textured versus smooth breast implants and to continue with routine medical care and follow-ups.
The FDA is calling on both doctors and patients to report any cases of ALCL in women with breast implants to its MedWatch adverse event reporting program.