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Breast Implant-Associated ALCL Resources

In 2011, the FDA reported a detailed analysis of 34 cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The recent FDA update summarizes the data reported to the MAUDE database, which as of September 10, 2015, represents 258 medical device reports (MDRs). Based upon this, the FDA estimates the total number of US cases of BIA- ALCL to be up to 250 cases. The FDA confirms women with breast implants do not need to change their routine medical care and follow-up. The FDA specifically recommends reporting all confirmed cases of ALCL and breast implants to both the FDA and the PROFILE Registry.