According to allegations raised in a recently filed product liability lawsuit, Allergans McGhan breast implants caused a Louisiana woman to develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. 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: Women who received Allergan textured implants should know the symptoms of BIA-ALCL and monitor their health. Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions. Because surgeons are not required to keep your records forever, contact them as soon as possible. Instructions for Downloading Viewers and Players. Retrieved from, U.S. Food and Drug Administration. Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions. (2019, June 25). 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. 3. McGhan and Inamed textured implants are also a part of the recall. Drugwatch.com partners with law firms. Information Update - Health Canada suspends Allergan's licenses for its Biocell breast implants after safety review concludes an increased risk of cancer. Please Do Not return any products that are not the subject of this recall. At this time, Allergan has not called for implants to be removed from patients who have already received them. with breast implants may be more likely to be diagnosed with anaplastic large The main injury claimed in Allergan breast implant lawsuits is BIA-ALCL, a rare type of cancer. Prior results do not predict a similar outcome. Drugwatch has a stringent fact-checking process. International Consortium of Investigative Journalists. 5-star reviewed medical and legal information site. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known. FDA Update on the Safety of Silicone Gel-Filled Breast Implants. without the FDA forcing the issue. Manufacturer Reason. If you have one of the recalled breast implants, contact the attorneys at Sauder Schelkopf by submitting your information below. If you have Allergan textured breast implants and were diagnosed with cancer, the FDA recommends that you have your implants removed. 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. 2. 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 SiliconeFilled Breast Implants, Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch, All Lots: Note:This product was not distributed within the US. For example, Sandra Rush a woman who filed an Allergan breast implant lawsuit received a McGhan textured saline implant in 1995. Allergan had previously recalled other products in its Natrelle line in 2015. The FDA is not recommending women have the breast implants removed if they are showing no symptoms. 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 error, the labels for these two lots were switched during packaging. Investors: Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Asymptomatic patients do not need to have implants removed even if they know their implants are part of the recall. Inamed Corp. 71 S Los Carneros Rd. (2015, June 8). (2019, July 24). But the company complied and halted all sales and recalled the devices. The breast implant recalls impact: Retrieved from, Hale, C. (2019, July 24). The FDA encourages women with recalled Allergan breast implants to learn and monitor for the symptoms of BIA-ALCL. Some women may choose to have breast reconstruction using another implant or their own fat tissue. With a cancer this rare, it can be difficult to generalize treatment success and prognosis, but studies indicate that BIA-ALCL is relatively treatable. An examination, including ultrasound and mammogram, revealed a build-up of fluid around that implant. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. The information on ConsumerSafety.org is provided for informational purposes only and is not intended to provide specific legal advice. 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. One of our content team members will be in touch with you soon. In late 2018, French regulatory agency Agence Nationale de Scurit du Mdicament (ANSM) requested Allergan recall its textured breast implants and tissue expanders from European markets. According to the lawsuit, Downey received McGhan breast implants after being diagnosed with bilateral breast cancer in 2000. Helped more than 12,000 people find legal help. +44 7725 758677 Her unique professional history alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a fresh perspective. The FDA first acknowledged a connection between breast implants and anaplastic large cell lymphoma in 2011. Complaint and Demand for Jury Trial. Number in Commerce: 167 units total, 114 in the United States, Number in Commerce: 23 units total, 16 in the United States. Weve also connected thousands of people injured by drugs and medical devices with top-ranked national law firms to take action against negligent corporations. United States Donate Advertisement Advertisement Advertisement Advertisement Advertisement Advertisement Advertisement Retrieved from, U.S. Food and Drug Administration. Sorry there is a continuing error in our system. Medical device recalls: Allergan. Retrieved from, Allergan. Whether you are planning surgery, considering implants, or supporting a loved one, welcome! The site is secure. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. Retrieved from, Rush v. Allergan et al. The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers. 09/11/2019 Allergan PLC McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380 3 12/31/2005 Inamed Corp McGhan Style 163-360cc . The FDA Women diagnosed with cancer may be eligible for settlement benefits. Retrieved from https://www.drugwatch.com/allergan-breast-implants/lawsuits/, Drugwatch. 2. 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 McGhan BioDIMENSIONAL SILICONEFILLED BREAST IMPLANTS, McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153. We appreciate your feedback. 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. (2019c). (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). 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. Allergan to recall textured A correction or removal action taken by a manufacturer to address a problem with a medical device. Textured breast implants have been associated with an increased risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The products included in the recall are: Lisa Brown Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus related topics: Breast Reconstruction U.S. FDA Resources Regular exposure to chemicals in hair relaxer may cause uterine cancer, ovarian cancer and other injuries. Update your browser for more security, speed and compatibility. We research breast reconstruction options, breast implant safety, and explant surgery. This global recall does not affect Allergan's NATRELLE smooth or MICROCELL breast implants and tissue expanders. 2. Retrieved from https://uk.reuters.com/article/us-allergan-recall/allergan-recalls-textured-breast-implants-worldwide-idUKKCN1UJ1N9, U.S. Food and Drug Administration (FDA). 800-624-4261 Ext. (2019a). If you have inventory of the recalled products, Quarantine product to prevent its use. 6. BIA-ALCL is a relatively rare type of cancer affecting a small percentage of all women with breast implants. The FDA says women who dont have symptoms of BIA-ALCL shouldnt remove their implants. To ensure we are able to account for all recalled product, it is imperative that you return the form. Allergan insisted the actions were not related to new safety issues and said ANSMs request was not based on new scientific evidence. 4. Our 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. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Allergan Voluntarily Recalls BIOCELL Textured Breast Implants and Tissue Expanders, Allergan Global Medical Information Contacts, Recent Recalled Product Photos on FDA's Flickr Photostream, Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX, Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX, Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch, Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM, Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM, Natrelle 150 Full Height and Short Height double lumen implants. 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. This global recall does not affect Allergan's NATRELLE smooth or MICROCELL breast implants and tissue expanders. 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. TGA gave manufacturers until July 24, 2019, to respond. This means that no one can sell Allergans Biocell breast implants in Canada or import them into the country.. 1. To ensure we are able to account for all recalled product, it is imperative that you return the form. Natrelle and McGhan Round Gel Implants . The recall letter will inform customers to do the following: FDA Links Breast Implants to Cancer, Allergan Issues Global Recall, July 2019 Recalled Allergan Textured Breast Implants & Instruments. This global recall does not affect Allergan's NATRELLE smooth or MICROCELL breast implants and tissue expanders. Upon receipt of the Response Form, Inmar will issue Return Authorization label(s). Please read our disclaimer for more information about our website. Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry. Allergan bought these companies and became responsible for these products and all liability associated with them. 4332 Empire Rd. From the U.S. FDA website, For patients who have no symptoms, removal of these or other types of breast implants is not recommended, due to the low risk of developing BIA-ALCL. The manufacturer took things a step further by promptly issuing a global recall of designated implants. BIA-ALCL. Typically, companies initiate a recall The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. All fifty (50) US States, the US Virgin Islands and Puerto Rico. 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 ! For Additional Information Contact. The FDA indicates there are at least 573 known cases of BIA-ALCL diagnosed worldwide, including 33 deaths. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, Breast, Inflatable, Internal, Saline, Code of Federal Regulations (CFR) Title 21 7.55, PMAs with Product Code = FWM and Original Applicant = Allergan, Instructions for Downloading Viewers and Players, Class 3 Device Recall McGhan Style 163360cc SalineFilled BIOCELL textured Breast Implants, McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360. In August 2022, the FDA reported that it had received 1,130 reports of BIA-ALCL, and 953 of those reports were related to Allergan implants. 2023 Copyright AboutLawsuits.com. Lawyers are reviewing Cartiva lawsuits for individuals who experienced complications after receiving the toe implant. The recall letter will inform customers to do the following: So women with older implants may be at increased risk. The recall also includes textured tissue expanders used to create space for a breast implant during reconstruction. ALL RIGHTS RESERVED. Retrieved from, Chavkin, S. (2019, July 11). for Recall. Find out if you may be eligible for a hearing loss settlement. Retrieved January 22, CNN . That means as many as 500 American women could learn they have BIA-ALCL this year. The recalled implants feature a textured surface designed to prevent slippage and to minimize scar . Allergan In October 2019, after noticing an enlargement in one of her breast implants, she was diagnosed with BIA-ALCL. 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. Though BIA-ALCL is a serious and potentially fatal disease, the risk of developing the cancer is low. (2019c). The initial status conference for recently consolidated hair relaxer lawsuits filed in federal courts nationwide will be held on Thursday. Media: On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). 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. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Having a family member with major depression and anxiety, I was looking for information on her medications. 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. OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam. In the United Kingdom, the UK.gov Class 1 Device Recall Natrelle and McGhan 410 Soft Touch breast implant . FDA Home; Medical Devices; Databases - 510(k) | DeNovo . Lawyers review cases nationwide. The FDA has not released the exact number of implants affected. 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. 2023 CSO Technology Partners, LLC. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. Injured by drugs and medical devices and their connections with their manufacturers out if you have any questions about recall. Update - Health Canada suspends Allergan 's current expectations depending upon a number factors! Indicates there are at least 573 known cases of BIA-ALCL shouldnt remove their implants are part of the breast! 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