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DeLauro Statement on Worldwide Recall of Textured Breast Implants

July 25, 2019

WASHINGTON, DC (July 25, 2019)Congresswoman Rosa DeLauro (CT-03) today released the following statement after the United States Food and Drug Administration (FDA) announced(link is external) a worldwide recall of Allergan textured breast implants linked to anaplastic large-cell lymphoma (ALCL).

"The fact that it took FDA so long to recommend recalling these dangerous breast implants is unconscionable. Make no mistake: the FDA has known about their link to egregious health issues for years. By failing to act, the FDA irreparably harmed women—some of whom have died. The FDA's mission is to safeguard consumers from harm, not wait until people are sick or dying before they ask a company to take a product off the market."

Since 2006, DeLauro has criticized(link is external) FDA's oversight of breast implants. When FDA reviewed data in 2011 that showed a link between certain breast implants and ALCL, DeLauro wrote the Agency and called for an investigation. In the years since, DeLauro has continued to call for FDA to take more aggressive action to protect women.

Last September, DeLauro met with patient advocates whose stories(link is external) were shared by The International Consortium of Investigative Journalists.

Earlier this year, DeLauro reintroduced the Medical Device Safety Act, which would increase access to legal recourse for victims of unsafe devices.