Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220,TRL
Check against the official notice below — it lists the full affected range.
Allergan PLC is recalling Natrelle Inspira silicone-filled breast implants in multiple style numbers (TRL, TRLP, TRM, and TRF) worldwide and throughout all fifty U.S. states, U.S. territories, and several countries including Canada, Japan, and others. The recall encompasses approximately 4 million breast implants and tissue expanders combined and was initiated following FDA notification of updated safety information showing a higher incidence of anaplastic large cell lymphoma (BIA-ALCL), a type of cancer, in patients with textured breast implants.
The recall specifically involves all lots of the textured Natrelle Inspira implants, identified by their style numbers and corresponding UDI codes listed in the product codes. The source document does not specify a remedy or recommended action for consumers who have received these implants.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution and US Nationwide All fifty (50) US States, the US Virgin Islands and Puerto Rico. (AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY). OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam. Quantity: 4,026,287 Breast Implants and Tissue Expanders Combined in total Lot/code info: ALL LOTS Product Code/UDI Style TRL: TRL-125 10888628007659, TRL-140 10888628007666, TRL-170 10888628007673, TRL-200 10888628007680, TRL-230 10888628007697, TRL-260 10888628007703, TRL-290 10888628007710, TRL-320 10888628007727, TRL-350 10888628007734, TRL-380 10888628007741, TRL-410 10888628007758, TRL-460 10888628007765, TRL-510 10888628007772, TRL-560 10888628007789, TRL-610 10888628007796; Style TRLP:TRLP-125 10888628007802, TRLP-145 10888628007819, TRLP-165 10888628007826, TRLP-190 10888628007833, TRLP-205 10888628007840, TRLP-220 10888628007857, TRLP-235 10888628007864, TRLP-250 10888628007871, TRLP-265 10888628007888, TRLP-280 10888628007895, TRLP-300 10888628007901, TRLP-320 10888628007918, TRLP-340 10888628007925, TRLP-360 10888628007932, TRLP-400 10888628007949, TRLP-440 10888628007956, TRLP-490 10888628007963, TRLP-540 10888628007970, TRLP-590 10888628007987, TRLP-640 10888628007994; Style TRM TRM-140 10888628008007, TRM-175 10888628008014, TRM-195 10888628008021, TRM-210 10888628008038, TRM-240 10888628008045, TRM-255 10888628008052, TRM-275 10888628008069, TRM-295 10888628008076, TRM-310 10888628008083, TRM-330 10888628008090, TRM-345 10888628008106, TRM-360 10888628008113, TRM-375 10888628008120, TRM-405 10888628008137, TRM-445 10888628008144, TRM-485 10888628008151, TRM-520 10888628008168, TRM-560 10888628008175, TRM-600 10888628008182, TRM-640 10888628008199, TRM-685 10888628008205, TRM-755 10888628008212; Style TRF: TRF-180 10888628008229, TRF-200 10888628008
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.