Reported Sep 18, 2019 · Ongoing
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style…
Allergan PLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allergan PLC · 2525 Dupont Dr · Irvine, CA · 92612-1531
Is this the product you have?
- Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile
- for the following style numbers
Style 110:110-090110-120110-150110-180110-210110-240110-270110-300110-330110-360110-390110-420110-450110-480110-510
- Style 115
115-150115-167115-185115-203115-222115-253115-272115-290115-322115-354115-378115-401115-435115-469115-507115-547115-586115-627115-666115-716
- Style 120120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands
- Product UsageBreast augmentation and Breast reconstruction
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 108886280021591088862800216610888628002173108886280021801088862800219710888628002203108886280022101088862800222710888628002234108886280022411088862800225810888628002265108886280022721088862800228910888628002296ALL LOTS Product Code/UDI STYLE 110:110-090 10888628002159, 110-120 10888628002166, 110-150 10888628002173, 110-180 10888628002180, 110-210 10888628002197, 110-240 10888628002203, 110-270 10888628002210, 110-300 10888628002227, 110-330 10888628002234, 110-360 10888628002241, 110-390 10888628002258, 110-420 10888628002265, 110-450 10888628002272, 110-480 10888628002289, 110-510 10888628002296 2 1088862800230210888628002319108886280023261088862800233310888628002340108886280023571088862800236410888628002371108886280023881088862800239510888628002401108886280024181088862800242510888628002432108886280024491088862800245610888628002463108886280024701088862800248710888628002494STYLE 115:115-150 10888628002302, 115-167 10888628002319, 115-185 10888628002326, 115-203 10888628002333, 115-222 10888628002340, 115-253 10888628002357, 115-272 10888628002364, 115-290 10888628002371, 115-322 10888628002388, 115-354 10888628002395, 115-378 10888628002401, 115-401 10888628002418, 115-435 10888628002425, 115-469 10888628002432, 115-507 10888628002449, 115-547 10888628002456, 115-586 10888628002463, 115-627 10888628002470, 115-666 10888628002487, 115-716 10888628002494 3 1088862800250010888628002517108886280025241088862800253110888628002548108886280025551088862800256210888628002579108886280025861088862800259310888628002609STYLE 120:120-180 10888628002500, 120-220 10888628002517, 120-260 10888628002524, 120-300 10888628002531, 120-340 10888628002548, 120-400 10888628002555, 120-440 10888628002562, 120-500 10888628002579, 120-550 10888628002586, 120-600 10888628002593, 120-650 10888628002609 - Amount recalled
- 4,026,287 Breast Implants and Tissue Expanders Combined in total
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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