The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2464-2019·Announced 2019-09-18

Allergan Textured Breast Implants Recalled Due to Lymphoma Risk

Allergan is recalling 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants."

Plain-English summary

Allergan PLC is recalling RITZ PRINCESS, BIOCELL, INTRASHIEL, and BioDIMENSIONAL Breast Implants (Styles RML, RMM, RFL, RFM) and tissue expanders. The recall involves 4,026,287 units combined. These products were used for breast augmentation and breast reconstruction.

The action was initiated following notification by the U.S. FDA of recently updated global safety information concerning a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

The products were distributed worldwide and across all 50 U.S. states, the U.S. Virgin Islands, and Puerto Rico. International distribution included Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan, and Vietnam. Patients with these implants should consult their healthcare providers regarding the updated safety information.

The recalled product

Product
RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction
Manufacturer
Allergan PLC
Category
Medical Device — Breast Implants
Hazard
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

Distributed nationwide across the United States.

The notice also names 52 states specifically:

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.

See all 15 products in this recall →

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