The Recall Desk
SevereFDA (Devices)·Z-2458-2019·Announced 2019-09-18

Allergan Recalls McGhan Tissue Expanders Due to Lymphoma Risk

Allergan is recalling McGhan Croissant-Shaped Tissue Expanders because the FDA identified a higher incidence of anaplastic large cell lymphoma in patients with textured breast 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 involves a medical device associated with a serious health condition (anaplastic large cell lymphoma) and is classified as FDA Class I, which meets the criteria for a Severe rating.

Plain-English summary

Allergan PLC is recalling McGhan Croissant-Shaped Tissue Expanders, Style 134. These devices are intended for temporary subcutaneous implantation and require periodic inflation with sterile saline to develop tissue. The recall covers 4,026,287 breast implants and tissue expanders combined.

The recall was initiated following notification by the U.S. Food and Drug Administration regarding updated global safety information. The FDA identified a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants. The distribution for these products was worldwide and US nationwide, including all fifty states, the US Virgin Islands, and Puerto Rico.

Patients who have these implants should contact their healthcare provider for guidance on next steps. The recall applies to all lots of the specified product.

The recalled product

Product
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
Manufacturer
Allergan PLC
Category
Medical Device — Breast Implants and Tissue Expanders
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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