A correction or removal action taken by a manufacturer to address a problem with a medical device. All fifty (50) US States, the US Virgin Islands and Puerto Rico. Note: If you need help accessing information in different file formats, see previously recommended this action. (2015, June 8). Lot#1121514, Serial# 11567927 & 11567935. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA). Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known. Doctors diagnosed her with BIA-ALCL in 2017. This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews. 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. 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. (2019, July 24). What are my options if I was diagnosed with cancer? Recalling Firm. Australia set to join nations banning textured breast implants over cancer links. 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. 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. 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. This global recall does not affect Allergan's NATRELLE smooth or MICROCELL breast implants and tissue expanders. Class 2 Device Recall Natrelle 133 Series Tissue Expander. Testing Positive for COVID-19: It Felt Like I Had a Compression Belt Around My Chest, COVID-19: A Consumers Guide to the Coronavirus, Trial Attorney and Pharmaceutical Litigation Expert, Philips CPAP Recall: Related MDRs Top 98K, Including 346 Deaths, Erika Sward of American Lung Association Reveals the Dangers of Vaping and IQOS, Texas Mother Warns About Breast Implant Dangers, This article contains incorrect information, This article doesn't have the information I'm looking for, Allergan Cites Rare Cancer as Reason for Breast Implant Recall, FDA Update on the Safety of Silicone Gel-Filled Breast Implants. A+ rating from the Better Business Bureau. McGhan Round Breast Implant, Saline-Filled BIOCELL textured. 3. Inamed Corp. 71 S Los Carneros Rd. +44 7725 758677 Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). 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. OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam. Instructions for Downloading Viewers and Players. Allergan Calling this number connects you with a Drugwatch representative. Recall letters were sent on August 6, 2019 via: FedEx overnight mail with tracking to all consignees who may have product within expiry. The recall also includes textured tissue expanders used to create space for a breast implant during reconstruction. (2022, September 8). To ensure we are able to account for all recalled product, it is imperative that you return the form. 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 3. 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 . 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. Instructions for Downloading Viewers and Players. 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. On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). 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 ! Our reporting is not done yet. TGA gave manufacturers until July 24, 2019, to respond. FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. Conduct a physical count of the affected products in your possession and record the count on the enclosed Recall Stock Response Form. Allergan issues worldwide recall of textured breast implants over cancer cases. Allergan loses CE mark for textured breast implants, opening EU market. FDA does not endorse either the product or the company. 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. Sorry there was an error. Class 2 Device Recall Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc. If you do not know what type of implants you have, again dont panic! Despite the low incidence of BIA-ALCL with the recalled implants, Allergan may still face lawsuits over this unexpected and serious side effect. U.S. healthcare providers with questions regarding this announcement can contact Medical Information at 1-800-678-1605 option #2 orIR-Medcom@allergan.com. At this time, Allergan has not called for implants to be removed from patients who have already received them. (2019b). However, if you have any questions, talk to your health care provider (FDA, 2019b). Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. 2020, from https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl#history, Physicians Weekly. Note: If you need help accessing information in different file formats, see NOTE: Providing information for review by an attorney does not form an attorney-client relationship. Breast implants and Anaplastic Large Cell Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. Retrieved from, U.S. Food and Drug Administration. CNN . 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. Class 1 Device Recall Natrelle and McGhan 410 Soft Touch breast implant . Patients should monitor for symptoms of BIA-ALCL and see a physician immediately if they experience any. In December 2011, Downey began suffering pain and swelling in her left breast. Allergan sold most of the recalled products under its Natrelle brand, but some Americans may have received older textured breast implants sold by McGhan and Inamed. Find your medical device registration card- if you were given one. The company sent recall letters to customers. Instructions for Downloading Viewers and Players. Later that year, in April 2012, she was diagnosed with anaplastic large cell lymphoma of the left breast. Lawsuitsagainst Retrieved from, U.S. Food And Drug Administration. On July 24, 2019, Allergan announced . FAQ on CE Mark Non-Renewal of Textured Breast Implants and Textured Tissue Expanders. Christine Chiou for Recall. 2. Investors: 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. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Attorney Advertising. 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). Retrieved from https://www.drugwatch.com/allergan-breast-implants/lawsuits/, Drugwatch. The incidence of BIA-ALCL is still relatively low, even for the recalled implants. 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. Reason: Labeling error. Lymphoma (ALCL): Information for clinicians and patients. In order to sell its breast implants in 33 European countries, Allergan needs a safety certificate known as a CE mark. Side effects of the Gardasil HPV vaccine have been linked to reports of serious and debilitating autoimmune injuries. The recall also includes textured tissue expanders used to create space for a breast implant during reconstruction. This website and its content may be deemed attorney advertising. Find out if your family may be eligible for a Tylenol autism or ADHD settlement. These include an implant sizer and tissue expanders. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. If you have one of the recalled breast implants, contact the attorneys at Sauder Schelkopf by submitting your information below. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. 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. All fifty (50) US States, the US Virgin Islands and Puerto Rico. 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. that was produced by Inamed Corp. A correction or removal action taken by a manufacturer to address a problem with a medical device. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and womens health issues. Note: We covered this type of implant in a previous story detailing a secret FDA reporting program that likely delayed this important recall. Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. 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) If your breast implant is on the recall list and you have no symptoms, the FDA does not recommend that you remove your implants. What Should I Do If My Implant Is Recalled? Prosthesis, Breast, Inflatable, Internal, Saline - Product Code FWM. Communication. It is not a substitute for professional medical advice, diagnosis or treatment. If you have Allergan textured breast implants and were diagnosed with cancer, the FDA recommends that you have your implants removed. The Premarket Approval or PMA number is a reference number for the original application the FDA used to approve the device for sale. 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