The Recall Desk
SevereFDA (Devices)·Z-2459-2019·Announced 2019-09-18

Allergan Recalls McGhan BioDIMENSIONAL Silicone-Filled Breast Implants

Allergan PLC is recalling McGhan BioDIMENSIONAL silicone-filled breast implants due to a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) associated with textured implants.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which the rubric mandates a minimum score of 4 (Severe). Additionally, the hazard involves a known cancer (BIA-ALCL) associated with the device.

Plain-English summary

Allergan PLC is recalling McGhan BioDIMENSIONAL silicone-filled breast implants, style 153, used for breast augmentation and reconstruction. The recall covers 4,026,287 breast implants and tissue expanders combined.

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

The affected products were distributed 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. All lots are affected.

The recalled product

Product
McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 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

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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