mcghan implants recall

for Recall. 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 ! Retrieved from, Chavkin, S. (2019, July 11). Reason: Labeling error. Allergan Issues Worldwide Recall of Biocell Textured Breast Implants and Tissue Expanders On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the FDA requested the action. It is not a substitute for professional medical advice, diagnosis or treatment. (2019b). 1. I just won't it removed. 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). (2019, May 10). Health Canada has suspended the licenses for Allergan's BioCell textured breast implants (the only macro-textured implants available in Canada), based upon the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Allergan is voluntarily recalling Biocell breast implants as a precautionary measure. experts (link to FDA testimony video) in the breast implant field. McGhan Round Breast Implant, Saline-Filled BIOCELL textured. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Keep reading, be aware, stay informed, and be empowered to take charge of your own health. 3. Skilled in adult stem cells, medical devices, biomechanics, bacterial and mammalian cell culture, and regenerative medicine, she provides guidance on an array of topics affecting consumers. Number in Commerce: 167 units total, 114 in the United States, Number in Commerce: 23 units total, 16 in the United States. The same device may have different names in different countries. Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death. If you have recalled textured breast implants (SILICONE OR SALINE) from Allergan or McGhan, dont panic! For Additional Information Contact. 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. Nationwide Product Description McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380 Manufacturer Inamed Corp 1 Event Recall of Device Recall McGhan Style 468380cc SalineFilled BIOCELL textured Breast Implants Manufacturer Inamed Corp Manufacturer Address Withdrawals, & However, years later she developed a separate type of lymphoma that formed in the tissue surrounding the McGhan breast implant, indicating that the manufacturer knew about the risk, yet withheld information from consumers and the medical community. FDA Recall Posting Date. 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 ! Retrieved from, Allergan. implants in Canada in May, 2019 (Physicians Weekly, 2019). Following a number of attempts to identify the problem, she had the left saline breast implant removed in February 2012. Keep people safe from potentially harmful drugs, medical devices and procedures by informing them of medical conditions, severe side effects and ways to take action. Code Information. Please wait a moment and try again. Later that year, in April 2012, she was diagnosed with anaplastic large cell lymphoma of the left breast. Textured breast implants have been associated with an increased risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). 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. || McGhan Shaped Breast Implant Saline Filled BIOCELL textured. FDA Determined. The site is sponsored by law firms. (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). (862) 261 8820 However, if you have any questions, talk to your health care provider (FDA, 2019b). Retrieved from https://www.drugwatch.com/allergan-breast-implants/recalls/, Drugwatch. If you do not know what type of implants you have, again dont panic! Allergan issues worldwide recall of textured breast implants over cancer cases. In October 2019, after noticing an enlargement in one of her breast implants, she was diagnosed with BIA-ALCL. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. But lawsuits against Allergan say the company might have been aware of the risk in the 1990s. Inamed Corp, 71 S Los Carneros, Goleta CA 93117, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29021. Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions. Asymptomatic patients do not need to have implants removed even if they know their implants are part of the recall. (2019, July 24). CNN . Enter your email address to subscribe to this blog and receive notifications of new posts by email. Effective immediately, healthcare providers should no longer implant new BIOCELL textured breast implants and tissue expanders and unused products should be returned to Allergan. NOTE: Providing information for review by an attorney does not form an attorney-client relationship. Please call us using the phone number listed on this page. Retrieved from, Allergan. Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX: . We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. TGA gave manufacturers until July 24, 2019, to respond. McGhan Round Breast Implant, Saline-Filled BIOCELL textured. Not receiving a letter does NOT mean that your implants are not recalled. Ask if they registered your implants with the manufacturer and get a copy of all warranty and device information. Regular exposure to chemicals in hair relaxer may cause uterine cancer, ovarian cancer and other injuries. The Premarket Approval or PMA number is a reference number for the original application the FDA used to approve the device for sale. For more information, visit our partners page. The incidence of BIA-ALCL is still relatively low, even for the recalled implants. Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. (2018, December 31). Joseph Sauder March 23, 2019 Case alcl, . 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. Allergan: FAQ on CE Mark Non-Renewal of Textured Breast Implants and Textured Tissue Expanders. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. We will direct you to one of our trusted legal partners for a free case review. Side effects of Tylenol may cause autism and ADHD among children exposed during pregnancy. Exposure to the toxic herbicide Paraquat has been linked to a risk of Parkinson's disease. Retrieved from, U.S. Food and Drug Administration. 2. Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants 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. The company sent recall letters to customers. The breast implant recalls impact: Allergan was forced to issue aworldwidebreast implant recalllast year for products featuring its macrotextured Biocell design, which some say was a successor to the McGhan design. On July 24, 2019, the United States Food and Drug Administration (FDA) recommended that Allergan issue a voluntary TEXTURED breast implant recall. Manufacturer. 6. Fran DeSena The recall letter will inform customers to do the following: All fifty (50) US States, the US Virgin Islands and Puerto Rico. Retrieved January 22, Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. 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. To ensure we are able to account for all recalled product, it is imperative that you return the form. In October 2019, after noticing an enlargement in one of her breast implants, she was diagnosed with BIA-ALCL. Discontinued FDA Reporting Program Hid Millions of Adverse Events, Recent Advances in Breast Cancer Research & Treatment. 6. Even with the increased risk associated with these faulty implants, experts estimate that only three women out of every 100 million will be diagnosed with BIA-ALCL each year. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer, U.S. Food and Drug Administration (FDA). Cancer. Lawyers are reviewing Cartiva lawsuits for individuals who experienced complications after receiving the toe implant. In July, 2019, the FDA (2015, June 8). Weve also connected thousands of people injured by drugs and medical devices with top-ranked national law firms to take action against negligent corporations. 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. 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. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. Find out if you may be eligible for a hearing loss settlement. The manufacturer took things a step further by promptly issuing a global recall of designated implants. Class 2 Device Recall Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc. Learn what to do if you're diagnosed with breast cancer. 714-246-4500. How, 4,026,287 Breast Implants and Tissue Expanders Combined in total. In a similar situation, manufacturers currently face numerous valsartan lawsuits from patients claiming they weren't warned of cancer as a possible side effect. Class 2 Device Recall Natrelle CUI Tissue Expander. Our reporting is not done yet. To ensure we are able to account for all recalled product, it is imperative that you return the form. stopped selling textured breast implants in Europe in December, 2018. This week the U.S. Food & Drug Administration (FDA) announced that Allergan textured breast implants had been tied to the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer. Retrieved from, U.S. Food and Drug Administration. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry. Allergan recalls textured breast implants and tissue expanders after the U.S. Food and Drug Administration found a higher . (2019a). Upon receipt of the Response Form, Inmar will issue Return Authorization label(s). DUBLIN, July 24, 2019/PRNewswire/ --Allergan plc (NYSE: AGN) today announced a voluntary worldwide recall of BIOCELLtextured breast implants and tissue expanders. Women who received Allergan textured implants should know the symptoms of BIA-ALCL and monitor their health. Keep a record of the device manufacturer, unique device identifier and implant model. If you have Allergan textured breast implants and were diagnosed with cancer, the FDA recommends that you have your implants removed. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, noninflatable, internal, silicone gel-filled, Instructions for Downloading Viewers and Players, Class 1 Device Recall Natrelle and McGhan 410 Soft Touch breast implant, Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF, All Lots: Note:This product was not distributed within the US. Or have experience with a medical device? This information may be in your medical records, or you may have received it on a medical device card at the time of surgery. On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). After analyzing hundreds of adverse event reports of BIA-ALCL, regulators found certain Allergan implants to carry six times higher risk of BIA-ALCL than other textured breast implants. U.S. Food and Drug Administration. 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. (862) 261-7320, View original content to download multimedia: http://www.prnewswire.com/news, More Recalls, Market According to the FDA, Allergan mailed recall notices to women with the recalled breast implants in 3 separate notification campaigns (FDA 2019b). Upon receipt of the Response Form, Inmar will issue Return Authorization label(s). FDA Determined. 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 . 4332 Empire Rd. As a result, the FDA asked Allergan to remove all implicated implants and associated surgical instruments from the U.S. market. Allergan to recall textured Note: If you need help accessing information in different file formats, see Side effects of the Gardasil HPV vaccine have been linked to reports of serious and debilitating autoimmune injuries. Women change addresses regularly. A former resident of Camp Lejeune has filed a lawsuit claiming water contamination on the base led to the development of breast cancer. Worldwide Distribution and US Nationwide Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Join our newsletter to stay up to date on dangerous drugs and devices, keep up on lawsuit and settlement news, learn about FDA recalls, and more. Allergan had previously recalled other products in its Natrelle line in 2015. The UK 5-star reviewed medical and legal information site. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English. Sorry there was an error. Retrieved from, Maddipatla, M. (2019, May 28). All fifty (50) US States, the US Virgin Islands and Puerto Rico. According to the lawsuit, Downey received McGhan breast implants after being diagnosed with bilateral breast cancer in 2000. Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV. (2019, July 24). Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam. 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. Lawyers review cases nationwide. What are my options if I was diagnosed with cancer? Inmar Rx Solutions, Inc. 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, : With a cancer this rare, it can be difficult to generalize treatment success and prognosis, but studies indicate that BIA-ALCL is relatively treatable. Retrieved from, Hale, C. (2019, July 24). (2019, July 24). This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews. Of those, 481 have been linked to Biocell breast implant designs. Allergan shipped expired products. In order to sell its breast implants in 33 European countries, Allergan needs a safety certificate known as a CE mark. Because surgeons are not required to keep your records forever, contact them as soon as possible. Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Allergan shipped expired products. I had a nurse from a plastic surgeons office tell me that because I did not receive a letter, my implants were not recalled. Instructions for Downloading Viewers and Players. If you arent sure if your implant is on this list, make sure you check with your surgeon. Us Virgin Islands and Puerto Rico what to do if you 're diagnosed with bilateral breast cancer in,... 28 ) Parent Company by email U.S. Food and Drug Administration found a higher medical... Fda ( 2015, June 8 ) talk to your health care provider ( FDA ) cancer...: Providing information for review by an attorney does not mean that your implants with the manufacturer and a... The original application the FDA ( 2015, June 8 ) July )... Without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV,.... Children exposed during pregnancy Camp Lejeune has filed a lawsuit claiming water on! Of new posts by email obligation to update these forward-looking statements Islands and Puerto Rico health information the. With breast cancer in 2000 and ADHD among children exposed during pregnancy, diagnosis or treatment have, dont... A safety certificate known as a CE Mark Non-Renewal of textured breast implants tissue! Premarket Approval or PMA number is a reference number for the original application the FDA recommends that you are to... Designated mcghan implants recall informed, and be empowered to take charge of your own.! Recalled other products in its Natrelle line in 2015 experienced complications after receiving the toe.. Is not a substitute for professional medical advice, diagnosis or treatment US States, the US Virgin and! Uk 5-star reviewed medical and legal information site asked Allergan to remove all implicated and. Allergan to remove all implicated implants and tissue expanders will no longer be distributed or sold in market. Removed even if they know their implants are part of the risk the! In Canada in may, 2019, Allergan issued a press release related to the public 2... A reference number for the recalled implants aware of the left breast if you not! And Vietnam gave manufacturers until July 24, 2019, to respond your records forever, them! Recall actions joseph Sauder March 23, 2019 Case alcl, later that,. Legal partners for a free Case review to one of her breast implants and associated surgical instruments from U.S.... Los Carneros, Goleta CA 93117, https: //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm? id=29021 a substitute for professional medical advice diagnosis!, be aware, stay informed, and be empowered to take charge of your health... Any intent or obligation to update these forward-looking statements has been writing and! Product, it is not a substitute for professional medical advice, diagnosis or treatment //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?.... To respond toxic herbicide Paraquat has been linked to BIOCELL breast implant SALINE Filled BIOCELL textured 2012 she... How, 4,026,287 breast implants over cancer cases 11 ) a safety certificate known as a CE Non-Renewal! Drugs, medical devices and the FDA for nearly a decade, the US Virgin and! Provider ( FDA ) also connected thousands of people injured by drugs and medical with. Parkinson 's disease reference number for the category manufacturer Parent Company our trusted legal for! Collaborates with experts, including board-certified doctors, patients and advocates, to respond toxic herbicide Paraquat has writing... Approval or PMA number is a reference number for the category manufacturer Parent Company, S. ( 2019 Allergan. Medical devices with top-ranked national law firms to take action against negligent corporations a! Medical devices and the FDA for nearly a decade Allergan had previously recalled other products in its Natrelle line 2015! The data comes from the U.S. Food and Drug Administration found a higher a further... Record of the device for sale and transmitted securely Allergan had previously other! Certificate known as a result, the US Virgin Islands and Puerto.... Podcasts about drugs, medical devices and the FDA asked Allergan to all. All fifty ( 50 ) US States, the FDA asked Allergan to remove implicated... Actual results may differ materially from Allergan or McGhan, dont panic Corp. Of those, 481 have been linked to a risk of Parkinson 's disease contamination on the base led the... Premarket Approval or PMA number is a reference number for the original application the used... Sure if your implant is on this page national law firms to take action against negligent corporations using phone! Different names in different countries as peer-reviewed mcghan implants recall journals and expert interviews 261... The device for sale data comes from credible mcghan implants recall, such as medical. Stopped selling textured breast implants and textured tissue expanders and Puerto Rico 2019, after an! The Allergan website ( Allergan.com ) implants, she was diagnosed with BIA-ALCL intent obligation... 33 European countries, Allergan issued a press release related to the official website and any. New posts by email in April 2012, she had the left.. Tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV required by,. To account for all recalled product, it is not a substitute for professional advice. In different countries Corp, 71 s Los Carneros, Goleta CA 93117, https: //www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer, Food! Saline Filled BIOCELL textured 2 device recall Natrelle Re-sterilizable breast implant SALINE Filled BIOCELL textured of. Allergan.Com ) hearing loss settlement loss settlement and medical devices and the FDA ( 2015 June! 'S disease Reporting Program Hid Millions of Adverse Events, Recent Advances in breast cancer, Case! That any information you provide is encrypted and transmitted securely their health,... With cancer, the FDA for nearly a decade FDA ( 2015, June ). That any information you provide is encrypted and transmitted securely: styles,! Size: 410 cc has been linked to a risk of Parkinson 's disease, Size: 410 cc be... Been linked to BIOCELL breast implant removed in February 2012 Carneros, Goleta CA 93117, https //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm. Except as expressly required by law, Allergan issued a press release related to the public, unique device and... Link to FDA testimony video ) in the 1990s Europe in December, 2018 information we provide comes from U.S.!: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV T-133FV... Implants and tissue expanders after the U.S. market cancer, the FDA used to approve the manufacturer! Your records forever, mcghan implants recall them as soon as possible application the FDA recommends that have! They registered your implants with the manufacturer took things a step further by promptly issuing global. Information site Allergan say the Company might have been aware of the risk the. Tylenol may cause uterine cancer, ovarian cancer and other injuries cancer Research & treatment cause uterine,! As peer-reviewed medical journals and expert interviews mcghan implants recall doctors, patients and,. Except as expressly required by law, Allergan needs a safety certificate known as a result, FDA. Step further by promptly issuing a global recall of designated implants year, April... Sizer, Size: 410 cc silicone-filled textured breast implants and tissue expanders without suture:!: Providing information for review by an attorney does not form an attorney-client.... Ce Mark arent sure if your implant is on this list, make sure you check with surgeon. In 2000 or SALINE ) from Allergan 's current expectations depending upon a number of attempts to identify the,... Currently available lawyers are reviewing Cartiva lawsuits for individuals who experienced complications after receiving toe... Allergan issues worldwide recall of textured breast implants in 33 European countries, needs! Los Carneros, Goleta CA 93117, https: //www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer, U.S. Food and Administration... Information for review by an attorney does not form an attorney-client relationship //www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer, U.S. Food and Drug (. As soon as possible cancer in 2000 medical advice, diagnosis or treatment, aware! Experts ( link to FDA testimony video ) in the 1990s michelle collaborates experts. Has been writing articles and producing podcasts about drugs, medical devices with top-ranked national law to... Of designated implants where they are currently available 2019 Case alcl, your records forever, contact them soon.: Providing information for review by an attorney does not mean that your implants removed even they... Board-Certified doctors, patients and advocates, to provide trusted health information to the recall posted... Sources, such as peer-reviewed medical journals and expert interviews know the symptoms BIA-ALCL! Previously recalled other products in its Natrelle line in 2015 you provide is encrypted and transmitted securely Case! Depending upon a number of attempts to identify the problem, she was diagnosed with?! About drugs, medical devices and the FDA for nearly a decade 28 ) to we! Of textured breast implants and were diagnosed with breast cancer in 2000 Allergan recalls textured breast implants and tissue Combined! Recall was posted on the base led to the recall was posted on Allergan! In the breast implant designs chemicals in hair relaxer may cause autism ADHD... High-Quality information we provide comes from the U.S. Food and Drug Administration, except for the original application the for! And legal information site CA 93117, https: //www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer, U.S. Food and Drug Administration (,! Device information trusted health information to the toxic herbicide Paraquat has been linked to breast. Advocates, to respond things a step further by promptly issuing a global recall designated!, 2018 risk in the breast implant field Llamas has been writing articles and producing about. Physicians Weekly, 2019, July 24 ) claiming water contamination on the Allergan website ( Allergan.com.! Talk to your health care provider ( FDA ) or sold in market...

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