FDA (Devices) recall action 83500
The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Allergan is recalling textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).
Allergan PLC is recalling specific textured breast implants and tissue expanders due to a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).
Allergan PLC is recalling Natrelle 133 tissue expanders due to a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) associated with textured breast implants.
Allergan is recalling textured Natrelle Inspira breast implants and tissue expanders following FDA safety updates linking these devices to a higher incidence of anaplastic large cell lymphoma.
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.
Allergan is recalling Natrelle 133 tissue expanders due to FDA safety information regarding a higher incidence of anaplastic large cell lymphoma in patients with textured breast implants.
Allergan is recalling 4 million textured breast implants worldwide after FDA safety updates linked them to a higher incidence of anaplastic large cell lymphoma.
Allergan is recalling Natrelle tissue expanders because the FDA identified a higher incidence of anaplastic large cell lymphoma in patients with textured breast implants.
Allergan PLC is recalling specific textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).
Allergan PLC is recalling specific textured silicone-filled breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).
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.
Allergan is recalling 4 million textured breast implants and tissue expanders worldwide due to an increased risk of anaplastic large cell lymphoma.
Allergan is recalling textured breast implants worldwide due to an increased risk of anaplastic large cell lymphoma (BIA-ALCL). Patients should consult their healthcare providers.
Allergan is recalling specific textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).
Allergan PLC is recalling Natrelle textured breast implants and tissue expanders worldwide due to an increased risk of anaplastic large cell lymphoma.