Allergan to recall textured breast implants in Canada. MENTOR SIZER SIMILAR UPDATEInformation Update - Health Canada suspends Allergan's licenses for its Biocell breast implants after safety review concludes an increased risk of cancer. Australia set to join nations banning textured breast implants over cancer links. Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). FDA takes action to protect patients from risk of certain textured breast implants requests Allergan voluntarily recall certain breast implants and tissue expanders from market. Allergan issues worldwide recall of textured breast implants over cancer cases. Allergan recalls textured breast implant tied to rare cancer. The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication. Withdrawn Affected Product Names and Styles. Breast implants and anaplastic large cell lymphoma. The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication. 2, 2019, Allergan announced it would recall the products from the Australian market. TGA gave manufacturers until July 24, 2019, to respond. Brands included in the proposed cancellation list were all Allergan textured implants. On July 11, 2019, the Australian Therapeutic Goods Administration proposed either canceling or suspending several textured implants because of their link to BIA-ALCL. At the time, the FDA had said it would not ban or recall any textured devices. “This means that no one can sell Allergan’s Biocell breast implants in Canada or import them into the country.”Īllergan said Health Canada’s decision didn’t match the positions held by other countries’ regulatory bodies, including the FDA, according to Reuters. “Because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licenses for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada),” the regulatory agency said in a press release. In May 2019, Health Canada suspended Allergan’s licenses to sell its macro-textured Biocell breast implants in Canada after a 2017 safety review found that the rate of BIA-ALCL in Canada is significantly higher in patients with those implants compared to other implants. But the company complied and halted all sales and recalled the devices. Natrelle 133 Tissue Expanders with suture tabsĪllergan insisted the actions were not related to new safety issues and said ANSM’s request was not based on new scientific evidence. Natrelle Biocelle Textured Soft Touch Silicone-Filled Breast Implants Natrelle Inspira Biocell Textured Cohesive Silicone-Filled Breast Implants Natrelle Inspira Biocell Textured Responsive Silicone-Filled Breast Implants Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast ImplantsĤ10 LL, 410 LM, 410 LF, 410 LX, 410 ML, 410 MM, 410 MF, 410 MX, 410 FL, 410 FM, 410 FF, 410 FXīiocell Textured Round Gel-Filled Implantsġ10, 115, 120 - Moderate, Midrange and High Projection MENTOR SIZER SIMILAR FULLAbout ġ63 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implantsġ68 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)ģ63 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full ProjectionĤ68 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants MENTOR SIZER SIMILAR PROFESSIONALOur writers are members of professional associations, including American Medical Writers Association, American Bar Association, The Alliance of Professional Health Advocates and International Society for Medical Publication Professionals. The information on has been medically and legally reviewed by more than 30 expert contributors, including doctors, pharmacists, lawyers, patient advocates and other health care professionals. This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews. is HONCode (Health On the Net Foundation) certified. Our team includes experienced medical writers, award-winning journalists, researchers and certified medical and legal experts. We’ve also connected thousands of people injured by drugs and medical devices with top-ranked national law firms to take action against negligent corporations. has provided reliable, trusted information about medications, medical devices and general health since 2008.
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