Allergan Recalls Textured Breast Implants Due to Lymphoma Risk
Allergan is recalling 4 million textured breast implants and tissue expanders worldwide due to an increased risk of anaplastic large cell lymphoma.
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 (anaplastic large cell lymphoma) where the source text does not explicitly report specific injury counts or fatalities, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Allergan PLC is recalling approximately 4,026,287 Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, and FX breast implants and tissue expanders. These products are used for breast augmentation and reconstruction. The recall covers distribution in all 50 US states, the US Virgin Islands, Puerto Rico, and several international locations including Canada, Japan, and Korea.
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. This specific type of lymphoma is associated with the textured surface of the recalled devices.
Patients who have received these implants should contact their healthcare provider to discuss the potential risks and appropriate next steps. The recall is voluntary and based on the updated safety data provided by the FDA.
The recalled product
- Product
- Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX 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
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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