The Recall Desk
HighFDA (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).

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) associated with a serious condition (BIA-ALCL) where the source text does not explicitly report specific injuries or fatalities, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported in the text.

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 →

Related recalls

Same manufacturer · Allergan PLC

See all →

Same hazard · lymphoma risk

See all →