Class 1 Device Recall McGhan BioDIMENSIONAL SILICONEFILLED BREAST IMPLANTS

• Date Initiated by Firm: July 24, 2019
• Date Posted: September 11, 2019
• Recall Status: Open, Classified
• Recall Number: Z-2459-2019
• Recall Event ID: 83500
• Product Classification: Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR
• Product: McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153; ; ; Product Usage: Breast augmentation and Breast reconstruction
• Code Information: ALL LOTS
• Recalling Firm/ Manufacturer: Allergan PLC; 2525 Dupont Dr; Irvine CA 92612-1531
• For Additional Information Contact: Nicole Katz; 714-246-4500
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: 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) On July 24, 2019, Allergan issued a press release related to the recall was posted on the Allergan website (Allergan.com). 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 letter will inform customers to do the following: 1. If you have inventory of the recalled products, Quarantine product to prevent its use. 2. Conduct a physical count of the affected products in your possession and record the count on the enclosed Recall Stock Response Form. 3. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. 4. Upon receipt of the Response Form, Inmar will issue Return Authorization label(s). 5. 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: Inmar Rx Solutions, Inc. 4332 Empire Rd. Fort Worth, TX 76155 6. Please Do Not return any products that are not the subject of this recall. Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions. 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. The patient letters informed customers of the following: 1. How
• Quantity in Commerce: 4,026,287 Breast Implants and Tissue Expanders Combined in total
• Distribution: Worldwide Distribution and US Nationwide All fifty (50) US States, the US Virgin Islands and Puerto Rico. (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). OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.