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FDA Confirms Link Between Breast Implants and Cancer

On Behalf of | Mar 27, 2017 | FDA Alerts

The Food and Drug Administration has announced that those who undergo breast augmentation using breast implants have an increased risk for developing anaplastic large cell lymphoma—a rare form of non-Hodgkins lymphoma.

According to safety communications, the FDA identified a possible link between the implants and anaplastic large cell lymphoma (ALCL) in 2011. At the time of those findings, reported cases of the disease did not offer enough data to suggest what factors that could have led to the increased risk. Through continued research over the past 6 years, the FDA has collected evidence to corroborate previous findings published by the World Health Organization, which indicate breast implant-associated ALCL as a rare cancer that can develop following breast implants.

The FDA has not yet been able to definitively state how many cases of ALCL can be linked to breast implants, as there is a significant lack of data in global reporting. However, the Administration has received more than 350 medical device reports related to BIA-ALCL since February 1, 2017.

What Patients Should Know

While the FDA has confirmed the link between the implants and ALCL, it also maintains that women with implants have a “very low, but increased risk” of developing the disease as compared to women without implants. The disease has most often been identified after patients or physicians noticed the accumulation of fluid near the implant, and during implant revision procedures.

The FDA has published guidance for patients who have received breast implants:

  • If you have breast implants, it is important to continue with routine care procedures as specified by your physician. In doing so, ask your individual physician or surgeon how to monitor your implants for changes or malformations.
  • Schedule routine examinations with your health care provider.
  • Submit any confirmed cases of BIA-ALCL to the FDA.

If you have undergone breast augmentation using breast implants, or are considering the procedure, it is essential that you understand the potential risks associated with the implants and stay informed of the results of continued research by the FDA and other organizations.

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