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# Class 1 Assigned to Allergan Breast Implant Recall
- URL: https://www.fdaweb.com/class-1-assigned-to-allergan-breast-implant-recall/
- Published: 2019-09-12T12:00:00.000Z
- Updated: 2026-09-15T01:49:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144991

FDA has classified as Class 1 an Allergan July recall of its Biocell textured breast implant products ([see story](https://www.fdaweb.com/fda-asks-allergan-to-recall-breast-implants/)). The recall also included tissue expanders used by patients before breast augmentation or reconstruction. The recall was requested by FDA to address what it described as protecting women from breast implant-associated anaplastic large cell lymphoma.

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 had been monitoring the issue since it first identified the possible association between breast implants and this form of lymphoma in 2011\. The safety notice highlighted 573 unique cases globally, with 33 patient deaths.