Textured implants from McGhan Medical are also included in the recall. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. With complete removal of the faulty implant and attached capsular (cancerous) tissue, only about 4% of patients experience a return of BIA-ALCL within five years of operation. If you have recalled textured breast implants (SILICONE OR SALINE) from Allergan or McGhan, dont panic! The information on ConsumerSafety.org is provided for informational purposes only and is not intended to provide specific legal advice. Allergan issues worldwide recall of textured breast implants over cancer cases. 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 does not endorse either the product or the company. DUBLIN, July 24, 2019/PRNewswire/ --Allergan plc (NYSE: AGN) today announced a voluntary worldwide recall of BIOCELLtextured breast implants and tissue expanders. Note: We covered this type of implant in a previous story detailing a secret FDA reporting program that likely delayed this important recall. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. 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. Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, St Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the followi McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380, McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360, Instructions for Downloading Viewers and Players. 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. Retrieved from, Maddipatla, M. (2019, May 28). McGhan Round Breast Implant, Saline-Filled BIOCELL textured. Update your browser for more security, speed and compatibility. Complaint and Demand for Jury Trial. Sorry there was an error. Patients should monitor for symptoms of BIA-ALCL and see a physician immediately if they experience any. Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, St. 3 12/18/2019 Allergan PLC . 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. McGhan and Inamed textured implants are also a part of the recall. The Premarket Approval or PMA number is a reference number for the original application the FDA used to approve the device for sale. The main injury claimed in Allergan breast implant lawsuits is BIA-ALCL, a rare type of cancer. Retrieved from, Lim, D. (2018, December 20). Review our editorial policy to learn more about our process for producing accurate, current and balanced content. Allergan has agreed to pay for the medical expenses of women who were diagnosed with BIA-ALCL after using its textured breast implants. Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL To ensure we are able to account for all recalled product, it is imperative that you return the form. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known. Manufacturer Reason. Having a family member with major depression and anxiety, I was looking for information on her medications. experts (link to FDA testimony video) in the breast implant field. Inmar Rx Solutions, Inc. Please read our disclaimer for more information about our website. Allergan shipped expired products. On July 11, 2019, the Australian Therapeutic Goods Administration proposed either canceling or suspending several textured implants because of their link to BIA-ALCL. Helped more than 12,000 people find legal help. U.S. healthcare providers with questions regarding this announcement can . implants in Canada in May, 2019 (Physicians Weekly, 2019). 4. You can download a raw copy of the database here. Allergan will provide additional information to customers about how to return unused products. Please Do Not return any products that are not the subject of this recall. For the hundreds of thousands of women who get breast implants yearly, news that a rare cancer may be associated with their implants can be understandably scary. With a cancer this rare, it can be difficult to generalize treatment success and prognosis, but studies indicate that BIA-ALCL is relatively treatable. Because many women have breast implants with a smooth surface, which have NOT been linked to BIA-ALCL, the overall percentage of all women with implants diagnosed with BIA-ALCL is small. Retrieved from https://www.drugwatch.com/news/2019/07/30/allergan-cites-rare-cancer-breast-implant-recall/, Gov.UK (2019). Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus related topics: Breast Reconstruction U.S. FDA Resources Retrieved from, Allergan. Following a number of attempts to identify the problem, she had the left saline breast implant removed in February 2012. Allergan said Health Canadas decision didnt match the positions held by other countries regulatory bodies, including the FDA, according to Reuters. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. We research breast reconstruction options, breast implant safety, and explant surgery. 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. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Fort Worth, TX 76155 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. Class 1 Device Recall Natrelle and McGhan SiliconeFilled Breast Implants. The FDA is not recommending women have the breast implants removed if they are showing no symptoms. I just, 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 ! The information on this website is proprietary and protected. -- 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 --. Our reporting is not done yet. As a result, the FDA asked Allergan to remove all implicated implants and associated surgical instruments from the U.S. market. Not all Allergan breast implants have been linked to cancer. Doctors diagnosed her with BIA-ALCL in 2017. Silicone Gel-Filled Breast Implants, https://www.drugwatch.com/allergan-breast-implants/lawsuits/, https://www.drugwatch.com/allergan-breast-implants/recalls/, https://www.drugwatch.com/news/2019/07/30/allergan-cites-rare-cancer-breast-implant-recall/, https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl#history, https://www.physiciansweekly.com/allergan-to-recall-textured/, https://uk.reuters.com/article/us-allergan-recall/allergan-recalls-textured-breast-implants-worldwide-idUKKCN1UJ1N9, https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer, 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, https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue#list, https://www.wsj.com/articles/abbvie-nears-deal-to-buy-allergan-for-more-than-60-billion-11561458504, Breast Reconstruction Options After Mastectomy, Removing the Entire Breast Implant Capsule. (2011, June). Christine Chiou Water contamination at Camp Lejeune in North Carolina between 1953 and 1987 caused cancers, birth defects, miscarriages and other side effects for U.S. Marines and their family members. For all other countries, please use the contact details at the following link on Allergan's website: Allergan Global Medical Information Contacts. On July 24, 2019, Allergan announced . Instructions for Downloading Viewers and Players. Patient letters were mailed on August 14, 19 and 26, 2019 to all impacted patients to which Allergan had complete names and addresses in their device tracking database. Paraquat Health Side Effects Hidden By Syngenta Since 1950s, Uncovered Documents Reveal, Lawyers to Meet with Hair Relaxer MDL Judge During Initial Status Conference March 2nd, Lawsuit Alleges Breast Cancer Caused By Camp Lejeune Water Contamination. It starts with our strict sourcing guidelines. 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