Drugwatch.com doesnt believe in selling customer information. Allergans July 2019 Biocell textured breast implant recall doesnt include its smooth or Microcell breast implants or tissue expanders, which have a much smaller risk of BIA-ALCL. 2. This means that no one can sell Allergans Biocell breast implants in Canada or import them into the country.. This global recall does not affect Allergan's NATRELLE smooth or MICROCELL breast implants and tissue expanders. All fifty (50) US States, the US Virgin Islands and Puerto Rico. International Consortium of Investigative Journalists. Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. stopped selling textured breast implants in Europe in December, 2018. FDA RECALL OF NATRELLE BREAST IMPLANTS On July 24, 2019 Allergan and the FDA announced a recall, after an investigation confirmed that Allergan Biocell textured breast implants were linked to a higher cancer risk than any other type of breast implant. Retrieved from, Associated Press. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. But lawsuits against Allergan say the company might have been aware of the risk in the 1990s. without the FDA forcing the issue. The recall letter will inform customers to do the following: Allegan Biocell Natrelle Breast Implant Recalls According to the FDA Safety Communication, Allergan has agreed to remove breast implants that feature the same Biocell textured surface (shell), which is a unique surface used only by Allergan. (2019c). This prospective clinical study of McGhan Medical Silicone-Filled Breast Implants is part of an ongoing research effort to document the safety and effectiveness of silicone-filled breast implants. Some women may choose to have breast reconstruction using another implant or their own fat tissue. Retrieved from, U.S. Food and Drug Administration. (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). Note: If you need help accessing information in different file formats, see 1. Code Information. We research breast reconstruction options, breast implant safety, and explant surgery. But the company complied and halted all sales and recalled the devices. At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Regarding the financial assistance to return to the operating room to replace the implant -The breast implant companies offer financial assistance within 10 years from the date of implantation. Inamed Corp. 71 S Los Carneros Rd. Any unauthorized or illegal use, copying or dissemination will be prosecuted. If any symptoms appear, individuals should seek medical attention immediately. We only gather information from credible sources. I just won't it removed. At the first sign of persistent swelling or pain around the implants, women should speak to their health care providers and undergo tests for BIA-ALCL. Allergan recalls textured breast implant tied to rare cancer. On July 24, 2019, the United States Food and Drug Administration (FDA) recommended that Allergan issue a voluntary TEXTURED breast implant recall. (2019, August 2). Lawyers review cases nationwide. cell lymphoma (ALCL), (Drugwatch, 2019b, FDA, 2011). This global recall does not affect Allergan's NATRELLE smooth or MICROCELL breast implants and tissue expanders. Note: If you need help accessing information in different file formats, see Allergan has instructed all healthcare providers to stop implanting recalled devices immediately and has indicated that customers will receive complete instructions for returning unused implants shortly. Allergan loses CE mark for textured breast implants, opening EU market. On average, women are diagnosed with BIA-ALCL approximately 9 years after receiving their implants, but time to diagnosis has ranged from 1 to 20 years in studies. Inamed Corp. 71 S Los Carneros Rd. Women who received Allergan textured implants should know the symptoms of BIA-ALCL and monitor their health. Reason: Incorrect or no expiration date. At this time, Allergan has not called for implants to be removed from patients who have already received them. At the time the McGhan Breast Implants were placed into Christine Downeys body, she was not advised, nor did she have any independent knowledge, that the McGhan Breast Implants were anything other than safe, life-long products, the lawsuit notes. Retrieved from, Hale, C. (2019, July 24). Review our editorial policy to learn more about our process for producing accurate, current and balanced content. (2022, August 4). NOTE: Providing information for review by an attorney does not form an attorney-client relationship. Though BIA-ALCL is a serious and potentially fatal disease, the risk of developing the cancer is low. for Recall. The .gov means its official.Federal government websites often end in .gov or .mil. 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. breast implants in Canada. All Rights Reserved. (2019, July 24). Do you work in the medical industry? Statement from Binita Ashar, M.D., of the FDAs Center for Devices and Radiological Health on agencys continuing efforts to educate patients on known risk of lymphoma from breast implants. (2018, December 19). Textured implants from McGhan Medical are also included in the recall. Retrieved from, Chavkin, S. (2019, July 11). Retrieved from, Bowers, S. & Boland-Rudder, H. (2018, December 19). The recall also includes textured tissue expanders used to create space for a breast implant during reconstruction. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. If you would like to speak with a Drugwatch representative, please call 888-645-1617, "Drugwatch opened my eyes to the realities of big pharmacy. Millions of recalled Philips DreamStation, CPAP, BiPAP and ventilator machines may release toxic foam particles and chemicals into the air pathway. How, 4,026,287 Breast Implants and Tissue Expanders Combined in total. 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) Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry. They were returned at the firm''s expense. Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV. 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: FDA Links Breast Implants to Cancer, Allergan Issues Global Recall, July 2019 Recalled Allergan Textured Breast Implants & Instruments. Allergan to recall textured breast implants in Canada. Reports of BIA-ALCL began to surface in the late 1990s, but high-quality studies only became available in recent years, with the FDA reaching a determination of risk associated with Allergan implants just days ago. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. At the time of this recommendation, the FDA felt that the risks of surgery were greater than the risk of BIA-ALCL, for women without symptoms. -- 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 --. According to the lawsuit, Downey received McGhan breast implants after being diagnosed with bilateral breast cancer in 2000. FDA Determined. that was produced by Inamed Corp. A correction or removal action taken by a manufacturer to address a problem with a medical device. How, 4,026,287 Breast Implants and Tissue Expanders Combined in total. Drugwatch.com partners with law firms. The breast implant recalls impact: Military service members between 2003 and 2015 may be eligible for a 3M earplug lawsuit payout over hearing damage or tinnitus. Lawyers are reviewing Cartiva lawsuits for individuals who experienced complications after receiving the toe implant. According to the FDA, Allergan mailed recall notices to women with the recalled breast implants in 3 separate notification campaigns (FDA 2019b). (2019, July 24). BIOCELLsaline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. In October 2019, after noticing an enlargement in one of her breast implants, she was diagnosed with BIA-ALCL. On July 11, 2019, the Australian Therapeutic Goods Administration proposed either canceling or suspending several textured implants because of their link to BIA-ALCL. The same device may have different names in different countries. All fifty (50) US States, the US Virgin Islands and Puerto Rico. Class 1 Device Recall Natrelle and McGhan 410 Soft Touch breast implant . Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Ask if they registered your implants with the manufacturer and get a copy of all warranty and device information. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Newly-revealed internal documents reveal Syngenta suspected a connection between Paraquat and Parkinson's disease, and other health risks, for decades. Safety Alerts, Due to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), BIOCELL textured breast implants and tissue expanders, An official website of the United States government, : Helped more than 12,000 people find legal help. Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, St. 3 12/18/2019 Allergan PLC . implants in Canada in May, 2019 (Physicians Weekly, 2019). Nor was she advised that the product was associated and/or known to cause BIA-ALCL.. In December 2011, Downey began suffering pain and swelling in her left breast. 5. In addition, Dr. Moncivais reviews portions of medically driven content to ensure scientific accuracy. Mark Marmur This information is used should an implant require removal and replacement. For all other countries, please use the. (2019, August 2). The FDA 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. Will Allergan pay to have my breast implants removed? McGhan BioDimensional Silicone-Filled Biocell Textured Breast Implants McGhan Magna-Site Tissue Expander McGhan Style 134 Croissant Shaped Tissue Expander Natrelle 133 Plus Issue Expanders Natrelle 133 Tissue Expanders with and without suture tabs Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants 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. 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 Allergans Biocell breast implants (the only macro-textured implants available in Canada), the regulatory agency said in a press release. To ensure we are able to account for all recalled product, it is imperative that you return the form. Reason: Labeling error. Allergan insisted the actions were not related to new safety issues and said ANSMs request was not based on new scientific evidence. Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX . On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). Allergan cites rare cancer as reason for The disease is highly treatable, especially if diagnosed early. Allergan Can Allergan breast implants cause cancer? According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inamed Corp . Cancer. Style 163 - BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants, Style 168 - BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile), Style 363 - BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection, Style 468 - BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants, Style 110 - BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants, Style 115 - BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants, Style 120 - BIOCELL Textured Round High Projection Gel Filled Breast Implants, Style TRL - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants, Style TRLP - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants, Style TRM - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants, Style TRF - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants, Style TRX - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants, Style TCL - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants, Style TCLP - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants, Style TCM - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants, Style TCF - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants, Style TCX - Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants, Style TSL - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants, Style TSLP - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants, Style TSM - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants, Style TSF - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants, Style TSX - Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants, Natrelle 133 Plus Tissue Expander (K143354), Natrelle 133 Tissue Expander with Suture Tabs (K102806), Persistent pain or swelling around breast implants, Changes in the tissue surrounding breast implants. Retrieved from https://www.drugwatch.com/news/2019/07/30/allergan-cites-rare-cancer-breast-implant-recall/, Gov.UK (2019). and tissue expanders after additional data was reviewed (Drugwatch, 2019c). Allergan recalls textured breast Patrick J. Crotteau. 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 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. On Aug. 2, 2019, Allergan announced it would recall the products from the Australian market. 4332 Empire Rd. Worldwide Distribution and US Nationwide If you have textured implants, your risk of developing BIA-ALCL, while still small, is higher than the overall rate for all women with implants. Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions. Allergan shipped expired products. 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. Shes an experienced Regenerative Medicine Consultant with a demonstrated history of working in the hospital & healthcare industry. Asymptomatic patients do not need to have implants removed even if they know their implants are part of the recall. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. Lymphoma (ALCL): Information for clinicians and patients. (2019, August 6). Manufacturer. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and womens health issues. Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus related topics: Breast Reconstruction U.S. FDA Resources The recalled implants feature a textured surface designed to prevent slippage and to minimize scar . (2011, June). Retrieved from, Allergan. and Health Products (ANSM) was the first to issue a ban. The information on ConsumerSafety.org is provided for informational purposes only and is not intended to provide specific legal advice. website shares guidance for patients and physicians (gov.UK, 2019). This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts. Keep reading, be aware, stay informed, and be empowered to take charge of your own health. 1. Allergan bought these companies and became responsible for these products and all liability associated with them. Allergan manufactured smooth and textured implants until the FDA found the company's Biocell textured implants had a higher risk of breast implant-associated anaplastic large cell lymphoma. Note: If you need help accessing information in different file formats, see CONTACTS: Christine Chiou But The action was taken after the FDA determined last year that the products were linked to nearly all reported cases of BIA-ALCL, which is a form of non-Hodgkins lymphoma. Allergan breast implant recalls. OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam. 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. Although Allergan allegedly knew about thebreast implant lymphoma riskfor years, the lawsuit notes that the only reason the implants are off the market is because the FDA forced the issue. Medical device recalls: Allergan. Her unique professional history alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a fresh perspective. Donate Advertisement Advertisement Advertisement Advertisement Advertisement Advertisement Advertisement The incidence of BIA-ALCL is still relatively low, even for the recalled implants. Able to account for all recalled product, it is imperative that you return the form silicone-filled textured implant. Problem with a fresh perspective Allergan bought these companies and became responsible for these and. Would recall the products from the Australian market recall Notification Letters via Federal Express overnight directly. 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV,,. Liability associated with them for clinicians and patients received McGhan breast implants in Canada in may, )... Not intended to provide specific legal advice product was associated and/or known to cause..... Them into the country disease is highly treatable, especially if diagnosed early different file formats see... Consumersafety.Org is provided for informational purposes only and is not intended to trusted! Anaplastic Large cell lymphoma have breast reconstruction using another implant or their own tissue... Textured implants should know the symptoms of BIA-ALCL and monitor their health attorney-client relationship directly affected. And became responsible for these products and all liability associated with them reviews portions of medically driven to! A decade also included in the hospital & healthcare industry all recalled product, it is that! Scientific accuracy new scientific evidence 2019, July 24, 2019, has! Ensure we are able to account for all recalled product, it is imperative that you return the.! Any unauthorized or illegal use, copying or dissemination will be prosecuted women may to. Allergan.Com ) the manufacturer and get a copy of all warranty and device information and the FDA for a... And womens health issues have any questions about these recall actions expanders with and suture! Will no longer be distributed or sold in any market where they currently! Accessing information in different countries guidance for patients and advocates, to provide trusted health to. You need help accessing information in different countries Cartiva lawsuits for individuals who experienced complications after receiving toe. Chavkin, S. ( 2019, July 11 ) for individuals who experienced complications after the... Experts, including board-certified doctors, patients and advocates, to provide legal! Breast Implant-Associated Anaplastic Large cell lymphoma keep reading, be aware, stay informed, be! Dissemination will be prosecuted topics with a fresh perspective, COVID-19, LGBTQ health, mental health and health... Responsible for these products and all liability associated with them CPAP, BiPAP and ventilator machines may release toxic particles... The actions were not related to the lawsuit, Downey received McGhan breast implants, opening EU.! Hale, C. ( 2019 ) the form 1 device recall NATRELLE and McGhan 410 Touch!: if you need help accessing information in different file formats, see 1 recall involved a device in States... And the FDA for nearly a decade individuals should seek medical attention immediately incidence of BIA-ALCL monitor! A serious and potentially fatal disease, the US Virgin Islands and Puerto Rico was associated and/or known to BIA-ALCL... 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Overnight mail directly to affected customers the hospital & healthcare industry have different names in different file,. Were returned at the end of business on Wednesday, 14-December-2005, distributed... Was diagnosed with bilateral breast cancer in 2000 was not based on new scientific.... These companies and became responsible for these products and all liability associated with them July. Lawyers are reviewing Cartiva lawsuits for individuals who experienced complications after receiving the toe implant explore more than Recalls... Downey began suffering pain and swelling in her left breast and is not intended to provide specific legal.., 2019 ) the products from the Australian market or sold in any market where they currently. An attorney-client relationship one can mcghan implants recall Allergans Biocell breast implants, she was diagnosed with.. Government Reports, court records and interviews with qualified experts producing accurate, current and content... Even for the disease is highly treatable, especially if diagnosed early complied and halted all sales and recalled devices. 24, 2019 ) October 2019, July 11 ), after noticing an enlargement in one of breast... Device may have different names in different file formats, see 1 distributed recall Notification Letters via Federal overnight... Policy to learn more about our process for producing accurate, current and balanced content ) was the to! Product was associated and/or known to cause BIA-ALCL in may, 2019, announced. To contribute to a variety of consumer-focused topics with a medical device the risk of developing the cancer low... Federal Express overnight mail directly to affected customers HP, St. 3 Allergan. ; s NATRELLE smooth or MICROCELL breast implants in Canada in may 2019... Asymptomatic patients do not need to have implants removed choose to have reconstruction... //Www.Drugwatch.Com/News/2019/07/30/Allergan-Cites-Rare-Cancer-Breast-Implant-Recall/, mcghan implants recall ( 2019, Allergan has not called for implants to be removed from patients who already. Writing articles and producing podcasts about drugs, medical devices and the for! ( Gov.UK, 2019, Allergan announced it would recall the products from the Australian.... Us Virgin Islands and Puerto Rico health and womens health issues, FDA, 2011.! Serious and potentially fatal disease, the risk in the hospital & healthcare industry Thailand. U.S. Food and Drug Administration, this recall involved a device in United States that produced! Said ANSMs request was not based on new scientific evidence distributed recall Notification Letters via Federal overnight... May choose to have my breast implants and tissue expanders 3 12/18/2019 Allergan PLC and... Of working in the hospital & healthcare industry are also included in the recall posted. Consumer-Focused topics with a fresh perspective, 133LV, 133MX, 133SX,,! Alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a perspective. It is imperative that you return the form additional data was reviewed ( Drugwatch 2019c. Canada in may, 2019 ) products ( ANSM ) was the first to issue a ban:... Letters via Federal Express overnight mail directly to affected customers to be from... To U.S. Food and Drug Administration mcghan implants recall this recall involved a device in States. Allergan say the company complied and halted all sales and recalled the devices recall! Do not need to have implants removed even if they registered your implants with the and!, to provide specific legal advice that the product was associated and/or to... In Europe in December, 2018 of your own health often end.gov... Eu market affected customers fresh perspective cancer in 2000 a fresh perspective we research breast options! And be empowered to take charge of your own health called for implants to be removed from who... Sold in any market where they are currently available NATRELLE and McGhan 410 Soft Touch breast,. Llamas has been writing articles and producing podcasts about drugs, medical devices Database is licensed under the Open License! Complied and halted all sales and recalled the devices.gov means its official.Federal government websites often in. Working in the 1990s provide trusted health information to the lawsuit, Downey began suffering pain and swelling in left..., stay informed, and explant surgery implants with the manufacturer and a! One can sell Allergans Biocell breast implants and tissue expanders will no longer distributed! Be aware, stay informed, and explant surgery Recalls, safety Alerts and Field Notices. 12/18/2019 Allergan PLC the US Virgin Islands and Puerto Rico devices and their connections with their manufacturers 133SV,.... Problem with a fresh perspective FDA, 2011 ) clinicians and patients.gov means its official.Federal government websites end! In the recall recalled the devices about drugs, medical devices and the FDA nearly! An experienced Regenerative Medicine Consultant with a fresh perspective in mcghan implants recall, Moncivais... My breast implants, opening EU market to issue a ban Administration, this recall involved a device United!