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FDA Asks Allergan to Recall Textured Breast Implants

Recently, 38 countries recalled textured breast implants produced by pharmaceutical company Allergan. The recalls are over a concern that the implants cause cancer of the immune system known as anaplastic large cell lymphoma or BIA-ALCL.

In March of 2017, the Food and Drug Administration announced that textured breast implants are likely connected to instances of BIA-ALCL. However, it did not take the implants off the market as it cited a need for further studies. Now, the FDA has asked the company Allergan to recall its textured breast implants in the United States as well.

Allergan Textured Breast Implants Show a Greater Risk for Cancer Than Other Brands

According to officials from the FDA, its recall of Allergan implants was influenced by evidence that they present a risk of cancer to recipients which is six times higher than implants produced by other companies.

“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA Principal Deputy Commissioner Dr. Amy Abernethy said.

The FDA also updated its recorded number of BIA-ALCL cases worldwide to 573. Of these cases, 481 of them are linked to Allergan implants. However, the FDA is not yet recommending that those without symptoms have their implants removed.

“We understand that today’s news may be alarming to some patients with breast implants. In the safety communication issued today, we’re providing actionable information for individuals with specific breast implants and their health care professionals. The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Women’s Health Advocates Are Concerned Cancer Risks

Women choose textured implants over non-textured implants because of how they interact with the tissues of the body. Textured breast implants stick to the body’s tissue, allowing them to stay in the same position over time. Women’s health advocates are expressing concern about what this recall means for women who had a mastectomy or for those who have them for augmentation.

"When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma," Said Diana Zuckerman, president of the National Center for Health Research. "This recall will reduce that risk but it won’t eliminate it, because not all women with BIA-ALCL had these specific types of implants."

If you or a loved one is suffering from BIA-ALCL and you think it might be related to Allergan breast implants, contact Arnold & Itkin right now at (888) 493-1629. Our Allergan breast implant attorneys are prepared to help you recover everything you need to move forward.