U.S. healthcare providers with questions regarding this announcement can contact Medical Information at 1-800-678-1605 option #2 or IR-Medcom@allergan.com. 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. Conduct a physical count of the affected products in your possession and record the count on the enclosed Recall Stock Response Form. We appreciate your feedback. Sorry there is a continuing error in our system. 714-246-4500. Allergan: All fifty (50) US States, the US Virgin Islands and Puerto Rico. Class 2 Device Recall Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc. Retrieved from, U.S. Food And Drug Administration. 2. Your web browser is no longer supported by Microsoft. risk of BIA-ALCL in 2011, updated in 2014, and in 2019. Retrieved from, U.S. Food and Drug Administration. with breast implants may be more likely to be diagnosed with anaplastic large 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. 1. 4. 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. Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions. Retrieved from, Maddipatla, M. (2019, May 28). Breast implants and Anaplastic Large Cell Women with breast implants may be more likely to be diagnosed with anaplastic large cell lymphoma (ALCL), the agency said in its 2011 FDA Update on the Safety of Silicone Gel-Filled Breast Implants. 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. Withdrawn Affected Product Names and Styles. Not all Allergan breast implants have been linked to cancer. Before sharing sensitive information, make sure you're on a federal government site. CNN . FDA Determined. (2019, July 24). Drugwatch.com is HONCode (Health On the Net Foundation) certified. Natrelle and McGhan Round Gel Implants . Medical device recalls: Allergan. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known. 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. Boarding & Prep School Sexual Abuse Lawsuit, generalize treatment success and prognosis, You can find more information about the recall and BIA-ALCL here >>, Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant), Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants), Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants, Allergan Tissue Expanders with BIOCELL Texturing. Drugwatch.com partners with law firms. You may also be eligible to file a lawsuit against the manufacturer. We want to hear from you. Her unique professional history alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a fresh perspective. mergers in the health sector this year. To ensure we are able to account for all recalled product, it is imperative that you return the form. You can download a raw copy of the database here. Allergan said Health Canadas decision didnt match the positions held by other countries regulatory bodies, including the FDA, according to Reuters. 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). (2019b). Editors carefully fact-check all Drugwatch content for accuracy and quality. Assisting patients and their families since 2008. Australia set to join nations banning textured breast implants over cancer links. 800-624-4261 Ext. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. (2018, December 19). 4332 Empire Rd. All fifty (50) US States, the US Virgin Islands and Puerto Rico. So women with older implants may be at increased risk. Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. But lawsuits against Allergan say the company might have been aware of the risk in the 1990s. Note: If you need help accessing information in different file formats, see Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants announced that it would recall and stop the sale of textured Biocell breast The patient letters informed customers of the following: Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English. On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). 3. The move came after the US Food . Find out if your family may be eligible for a Tylenol autism or ADHD settlement. 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. OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam. Allergan recalls textured breast implants and tissue expanders after the U.S. Food and Drug Administration found a higher . 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. Retrieved from https://www.drugwatch.com/news/2019/07/30/allergan-cites-rare-cancer-breast-implant-recall/, Gov.UK (2019). Most cases of BIA-ALCL occur many years after receiving a textured implant, according to the FDA. 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) According to the lawsuit, Downey received McGhan breast implants after being diagnosed with bilateral breast cancer in 2000. stopped selling textured breast implants in Europe in December, 2018. Having a family member with major depression and anxiety, I was looking for information on her medications. 1. 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. (2011, June). 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. Note: We covered this type of implant in a previous story detailing a secret FDA reporting program that likely delayed this important recall. Worldwide Distribution and US Nationwide 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 recall also includes textured tissue expanders used to create space for a breast implant during reconstruction. breast implant recall. Retrieved from, Bowers, S. & Boland-Rudder, H. (2018, December 19). Withdrawals, & On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). 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. Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX: . Women diagnosed with BIA-ALCL will have to have the implant and surrounding scar tissue removed. Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry. Patients should monitor for symptoms of BIA-ALCL and see a physician immediately if they experience any. 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. The disease is highly treatable, especially if diagnosed early. Class 2 Device Recall Natrelle CUI Tissue Expander. The FDA also indicated that the breast implant cancer problems have resulted in: Enter your email address to subscribe to this blog and receive notifications of new posts by email. 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. 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. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. (2019, August 2). 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. 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. This website does not provide medical advice, probable diagnosis, or recommended treatments. FAQ on CE Mark Non-Renewal of Textured Breast Implants and Textured Tissue Expanders. 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 ! 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. 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. And Vietnam consumer-focused topics with a fresh perspective found a higher the company might been... 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