BIA-ALCL is a relatively rare type of cancer affecting a small percentage of all women with breast implants. Allergan Drugwatch.com doesnt believe in selling customer information. Retrieved from, Hale, C. (2019, July 24). The complaint (PDF) was filed by Christine Downey and her husband, Drake, in the U.S. District Court for the Western District of Louisiana on August 3, indicating that the cancer was caused by the companys Biocell textured surface process used for the recalled breast implants. With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. Allergan has agreed to pay for the medical expenses of women who were diagnosed with BIA-ALCL after using its textured breast implants. Update your browser for more security, speed and compatibility. Natrelle and McGhan Round Gel Implants . cell lymphoma (ALCL), (Drugwatch, 2019b, FDA, 2011). FDA Links Breast Implants to Cancer, Allergan Issues Global Recall, July 2019 Recalled Allergan Textured Breast Implants & Instruments. Women diagnosed with cancer may be eligible for settlement benefits. Some of her qualifications include: Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Retrieved from. Retrieved from https://www.wsj.com/articles/abbvie-nears-deal-to-buy-allergan-for-more-than-60-billion-11561458504. U.S. data is current through June 2018. 4. The incidence of valsartan-associated cancer is lower than that of BIA-ALCL, so we may begin to see textured breast implant lawsuits filed in the very near future. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Prosthesis, Breast, Inflatable, Internal, Saline - Product Code FWM. The breast implant recalls impact: These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2019. 2023 Drugwatch.com Privacy Policy / Advertising Disclosure / Retrieved from, U.S. Food and Drug Administration. (2019b). (2019a). Reason: Incorrect or no expiration date. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to: Retrieved from, Allergan. DUBLIN, July 24, 2019/PRNewswire/ --Allergan plc (NYSE: AGN) today announced a voluntary worldwide recall of BIOCELLtextured breast implants and tissue expanders. However, if you have any questions, talk to your health care provider (FDA, 2019b). CLIA | TPLC : New Search: Back to Search Results : Class 1 Device Recall Natrelle and McGhan 410 Soft Touch breast implant: Date Initiated by Firm: July 24, 2019: Date Posted: September 11, 2019: Recall Status 1 . In December 2011, Downey began suffering pain and swelling in her left breast. Retrieved from https://uk.reuters.com/article/us-allergan-recall/allergan-recalls-textured-breast-implants-worldwide-idUKKCN1UJ1N9, U.S. Food and Drug Administration (FDA). Quoting financial analysis in the UK, Reuters speculated that a direct financial impact from the recall would be negligible for Allergan, which announced its sale to AbbVie, Inc. for $63 billion prior to the FDA recall (Reuters, 2019, Wall Street Journal, 2019). Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). For more information, visit our partners page. U.S. healthcare providers with questions regarding this announcement can contact Medical Information at 1-800-678-1605 option #2 orIR-Medcom@allergan.com. This global recall does not affect Allergan's NATRELLE smooth or MICROCELL breast implants and tissue expanders. Allergan issued a worldwide recall on July 24, 2019, but other countries had already asked the company to stop selling its implants because of BIA-ALCL concerns. The main injury claimed in Allergan breast implant lawsuits is BIA-ALCL, a rare type of cancer. Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue#list, Wall Street Journal. What is this? Drugwatch has a stringent fact-checking process. In September 2022, the FDA received additional reports of other types of cancer not related to BIA-ALCL found in scar tissue of smooth and textured implants. All fifty (50) US States, the US Virgin Islands and Puerto Rico. Side effects of the Gardasil HPV vaccine have been linked to reports of serious and debilitating autoimmune injuries. The patient letters informed customers of the following: A+ rating from the Better Business Bureau. In May 2019, Health Canada suspended Allergans 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. 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. Note: If you need help accessing information in different file formats, see Allergan was forced to issue a worldwide breast implant recall last year for. -- Global Action Follows Notification of Updated Safety Information from the U.S. Food and Drug Administration (FDA) --, -- FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients --, --Smooth and MICROCELLBreast Implants and Tissue Expanders Not Impacted --. (2019, August 2). Women may face a risk of Anaplastic Large Cell Lymphoma (ALCL) from certain breast implants. If your breast implant is on the recall list and you have no symptoms, the FDA does not recommend that you remove your implants. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to: How, 4,026,287 Breast Implants and Tissue Expanders Combined in total. 1. The information on ConsumerSafety.org is provided for informational purposes only and is not intended to provide specific legal advice. Textured breast implants have been associated with an increased risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). implants worldwide. Retrieved from, U.S. Food and Drug Administration. The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. (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). Retrieved 2020, January 22, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=&productdescriptiontxt=&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢erclassificationtypetext=&recallnumber=&postdatefrom=09%2F10%2F2019&postdateto=09%2F12%2F2019&productshortreasontxt=&firmlegalnam=Allergan&PMA_510K_Num=&pnumber=&knumber=&PAGENUM=500, U.S. Food and Drug Administration (FDA). Inmar Rx Solutions, Inc. I just won't it removed, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), centralized as part of a multidistrict litigation (MDL), Paraquat Sprayed on Family Farm Led to Symptoms of Parkinson's Disease, Lawsuit Claims, Parkinson's Disease Cases Diagnosed Each Year Are 50% Higher Than Prior Estimates, With Increased Incidents in Certain Areas, Hair Relaxer Lawsuit Information and Updates, Hair Relaxer Chemicals Caused Uterine Cancer, Lawsuit Alleges, Hair Relaxer Wrongful Death Lawsuit Filed Over Ovarian Cancer Caused By Chemical Straighteners, Non-Hodgkin's Lymphoma Lawsuit Filed Over Camp Lejeune Water Contamination, Marine Files Camp Lejeune Lawsuit Over Death of Daughter, After Fighting For Justice Over Water Contamination. Drugwatch.com is HONCode (Health On the Net Foundation) certified. Fortunately, less than 5% of breast implants sold in the United States are textured like the recalled implants, and only specific Allergan implants have been associated with an increased risk of BIA-ALCL. Allergan issues worldwide recall of textured breast implants over cancer cases. Allergans smooth implants are not a part of the July 2019 recall. The FDA provided this list of recalled Allergan products sold in the United States. Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Medical devices help to diagnose, prevent and treat many injuries and diseases. Drugwatch.com partners with law firms. While textured implants like those sold by Allergan make up a relatively small percentage of the U.S. market, in Europe and other countries it is as high as 80 percent. mergers in the health sector this year. Specific models of Allergan breast implants are associated with 6x greater risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) versus other textured breast implants. (2018, December 31). Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Note: If you need help accessing information in different file formats, see Women who received Allergan textured implants should know the symptoms of BIA-ALCL and monitor their health. Please Do Not return any products that are not the subject of this recall. A Tennessee woman has filed a product liability lawsuit that indicates Allergan McGhan breast implants caused cancer to develop in the tissue surrounding implant, known as breast. earlier, in the 1990s (Drugwatch, 2019a). Drugwatch is located at: This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews. UPDATE: On June 1, 2020, Allergan issued a press release outlining a dedicated multi-channel campaign to contact women who may not be aware of the Biocell recall and to improve tracking information for U. S. Breast Implant patients (link: https://news.abbvie.com/news/press-releases/allergan-aesthetics-launches-dedicated-multi-channel-campaign-to-contact-patients-who-may-not-be-aware-biocell-recall-and-to-improve-tracking-information-for-us-breast-implant-patients.htm) 5. Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry. The .gov means its official.Federal government websites often end in .gov or .mil. (2018, December 19). 2. Retrieved January 22, Not receiving a letter does NOT mean that your implants are not recalled. Retrieved from https://www.drugwatch.com/allergan-breast-implants/lawsuits/, Drugwatch. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known. But the company complied and halted all sales and recalled the devices. Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry. Inmar Rx Solutions, Inc. (862) 261-7162 ALL RIGHTS RESERVED. Worldwide Distribution and US Nationwide 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. That means as many as 500 American women could learn they have BIA-ALCL this year. To ensure we are able to account for all recalled product, it is imperative that you return the form. I just [Show More]I have a Allegan breast in plant after mastectomy I am so angry I live in Australia and had it done under the public system i don't have a leg to stand on regarding compensation and the the sergon that performed my operation has made his money and no longer practices I have been that sick from my implant Allegan in Australia only offers to replace my implant with another It's a disgrace ! Please wait a moment and try again. Retrieved from, Bowers, S. & Boland-Rudder, H. (2018, December 19). Of those, 481 have been linked to Biocell breast implant designs. Top Three Messages for Breast Implant Recipients. Goleta CA 93117-5506. for Recall. FDA Determined. Note: If you need help accessing information in different file formats, see You can download a raw copy of the database here. The FDA has linked Allergans textured breast implants, mostly those sold under the Natrelle brand, to a rare cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. Testing Positive for COVID-19: It Felt Like I Had a Compression Belt Around My Chest, COVID-19: A Consumers Guide to the Coronavirus, Trial Attorney and Pharmaceutical Litigation Expert, Philips CPAP Recall: Related MDRs Top 98K, Including 346 Deaths, Erika Sward of American Lung Association Reveals the Dangers of Vaping and IQOS, Texas Mother Warns About Breast Implant Dangers, This article contains incorrect information, This article doesn't have the information I'm looking for, Allergan Cites Rare Cancer as Reason for Breast Implant Recall, FDA Update on the Safety of Silicone Gel-Filled Breast Implants. https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda, https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma, https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue, https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma, https://www.allergan.com/-/media/allergan/documents/us/Products/Biocell/Affected-Products-List.pdf, https://www.statnews.com/2019/07/24/allergan-recalls-textured-breast-implant-tied-to-rare-cancer/, https://www.fiercebiotech.com/medtech/allergan-issues-worldwide-recall-textured-breast-implants-over-cancer-cases, https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan, https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl, https://www.icij.org/investigations/implant-files/australia-set-to-join-nations-banning-textured-breast-implants-over-cancer-links/, https://www.newswire.ca/news-releases/information-update-health-canada-suspends-allergan-s-licences-for-its-biocell-breast-implants-after-safety-review-concludes-an-increased-risk-of-cancer-880208806.html, https://www.reuters.com/article/us-allergan-canada/allergan-to-recall-textured-breast-implants-in-canada-idUSKCN1SY2BX, https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-5-10-bia-alcl-rush-complaint.pdf, https://www.fda.gov/news-events/press-announcements/statement-binita-ashar-md-fdas-center-devices-and-radiological-health-agencys-continuing-efforts, https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allerganinvestors/financial-information/proxy-materials/2018_10-k.pdf, https://www.medtechdive.com/news/allergan-loses-ce-mark-for-textured-breast-implants-opening-eu-market/544885/, https://news.abbvie.com/news/allergan-press-releases/allergan-suspends-sales-and-withdraws-supply-textured-breast-implants-in-european-markets.htm, https://www.allergan.com/-/media/allergan/documents/us/Investors/FAQs/FAQonCEMarkNonRenewalofTexturedBreastImplantsandTexturedTissueExpandersBreastImplantsInvestorFAQs.pdf, https://www.icij.org/investigations/implant-files/allergan-textured-breast-implants-recalled-in-europe-pending-safety-review/, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137978, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137741, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137972, 163 BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants, Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants, 410 LL, 410 LM, 410 LF, 410 LX, 410 ML, 410 MM, 410 MF, 410 MX, 410 FL, 410 FM, 410 FF, 410 FX, Biocell Textured Round Gel-Filled Implants, 110, 115, 120 Moderate, Midrange and High Projection, Natrelle Inspira Biocell Textured Responsive Silicone-Filled Breast Implants, Natrelle Inspira Biocell Textured Cohesive Silicone-Filled Breast Implants, Natrelle Biocelle Textured Soft Touch Silicone-Filled Breast Implants, Natrelle 133 Tissue Expanders with suture tabs. McGhan and Inamed textured implants are also a part of the recall. The site is secure. Textured implants from McGhan Medical are also included in the recall. The compensation will vary depending on whether the patient has already been diagnosed with cancer or is choosing to have them removed as a preventative measure. Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Unlike the textured implant recall, these recalls involved a relatively small number of devices. Any unauthorized or illegal use, copying or dissemination will be prosecuted. Information Update - Health Canada suspends Allergan's licenses for its Biocell breast implants after safety review concludes an increased risk of cancer. Recalling Firm. BII is not JUST about the Breast Implants, FDA Update on the Safety of According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inamed Corp . The companys CE mark for the products expired in December 2018 after a French certification firm decided not to renew it because of BIA-ALCL concerns. that was produced by Inamed Corp. A correction or removal action taken by a manufacturer to address a problem with a medical device. Lawyers are reviewing Cartiva lawsuits for individuals who experienced complications after receiving the toe implant. Our team includes experienced medical writers, award-winning journalists, researchers and certified medical and legal experts. On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). The company complied and halted all sales and recalled the devices reports of serious and autoimmune... Drugwatch, 2019b ) women may face a risk of cancer affecting small. ( ALCL ), ( Drugwatch, 2019a ) ( FDA, 2019b ) information ConsumerSafety.org! Code FWM a small percentage of all women with breast implants to cancer, Allergan worldwide... Small number of devices & Instruments writers, award-winning journalists, researchers and certified medical and legal experts, 19. Breast Implant-Associated Anaplastic Large Cell Lymphoma ( BIA-ALCL ) who were diagnosed with may!, a rare type of cancer mcghan and Inamed textured implants from mcghan medical are also included in the (! Textured implant recall, July 2019 recall pay for the medical expenses of women who diagnosed... To reports of breast Implant-Associated Anaplastic Large Cell Lymphoma ( ALCL ), ( Drugwatch, 2019b.. The medical expenses of women who were diagnosed with BIA-ALCL after using its breast... Cancer may be eligible for settlement benefits smooth or MICROCELL breast implants Allergan implants were linked. 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