> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Asks Allergan to Recall Breast Implants
- URL: https://www.fdaweb.com/fda-asks-allergan-to-recall-breast-implants/
- Published: 2019-07-24T12:00:00.000Z
- Updated: 2026-09-15T01:40:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144601

FDA says it is taking “significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)” by asking Allergan to recall specific models of its textured breast implants from the U.S. market. An agency [statement](https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan?ref=fdaweb.com) says the company has indicated it is moving forward with a worldwide recall of its Biocell textured breast implant products. The recall also includes tissue expanders used by patients before breast augmentation or reconstruction.

The agency also has issued a [safety communication](https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan?ref=fdaweb.com) outlining the known risks and steps patients should consider when monitoring for symptoms of breast implant-associated anaplastic large cell lymphoma, including swelling and pain in the breasts.

FDA has been monitoring the issue since it first identified the possible association between breast implants and anaplastic large cell lymphoma in 2011, the FDA statement says. A table on the agency’s BIA-ALCL Web page summarizes cases that have been found, with a breakdown of important information such as breast implant surface texture, patient age at diagnosis, time from last implant to diagnosis, and other details needed by patients and healthcare professionals, the statement says. It shows 573 unique cases globally, with 33 patient deaths. FDA says the total reflects a significant increase in known cases since the agency’s last update earlier this year.