FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants

Posted 21 March 2017 By Zachary Brennan

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The US Food and Drug Administration (FDA) on Tuesday said it now concurs with the World Health Organization’s designation of an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma.

"Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants," FDA said. "The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data. 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."

As of 1 February 2017, FDA said it has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. Of these, 231 reports included information on the implant surface and 203 were reported to be textured implants and 28 reported to be smooth implants.

In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants were filled with silicone gel and 126 reported implants were filled with saline.

Other Regulators and Literature

FDA notes that the Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of 46 confirmed cases of BIA-ALCL in Australia, including three deaths. None of the cases occurred in women with smooth implants, FDA said, noting that TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.

France’s National Agency for Medicines and Health Products Safety (ANSM) also has asked manufacturers of textured breast implants to perform biocompatibility testing, or what FDA said is "testing to determine how living tissues react to textured implants," and to report their findings within a year.

significant body of medical literature has been published since FDA’s 2011 report, the agency noted, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease.

"All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation," FDA said.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

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Categories: Medical Devices, Compliance, Quality, Regulatory strategy, Regulatory intelligence, News, US, FDA, TGA, WHO

Tags: breast implants, lymphoma, BIA-ALCL

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