Allergan Recalls Textured Breast Implants Due to Lymphoma Risk
Allergan is recalling specific textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly states the agency classification is Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Allergan PLC is recalling Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implants and tissue expanders. The affected styles include LL, LM, LF, ML, MM, MF, FL, FM, and FF. These products were used for breast augmentation and reconstruction.
The recall was initiated after the U.S. Food and Drug Administration (FDA) provided updated global safety information indicating a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients with textured breast implants. The agency classified this recall as Class I.
The recall covers 4,026,287 breast implants and tissue expanders combined. Distribution was worldwide and nationwide in the United States, including all 50 states, the US Virgin Islands, and Puerto Rico. International distribution included Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan, and Vietnam. Patients with these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction
- Manufacturer
- Allergan PLC
- Category
- Medical Device — Breast Implants
- Affected units
- 4,026,287
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots: Note:This product was not distributed within the US
Distribution
Part of a larger recall action
This product is one of 15 recalled by Allergan PLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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