The FDA Orders Voluntary Recall of Allergan Breast Implants

On 25 July 2019, the FDA has asked the breast implant manufacturer Allergan to recall its textured implants currently available in the United States. According to the FDA, Allergan is “moving forward with a worldwide recall.”

On a worldwide scale, textured breast implants have been linked to 573 cases of anaplastic large-cell lymphoma, and 33 people have died, according to updated numbers from the FDA. An overwhelming majority of both the cancer diagnoses—481—as well as the deaths in which the maker of the implant is known—12 out of 13—resulted from Allergan implants.¹

Specifically, the recalled products include:

Biocell products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients before breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

Important Recommendations to Patients Have Allergan breast Implants²:

If there are no symptoms, the FDA does not recommend removal of the breast implants.

The symptoms are: persistent swelling, pain and redness;

If you have symptoms, talk to your doctor so that you can receive early workup to confirm/exclude the diagnosis of BIA_ALCL;

Based on the confirmed diagnosis, an en-block removal of implant and capsule should be performed. This is more extensive operation than implant removal alone;

You should keep a record of your implant device identifiers;

You should know that the latent period of BIA-ALCL is usually long, although the chance is low, you should see your surgeon regularly for follow-up care.