McGhan BioDIMENSIONAL silicone-Filled Breast Implants recall
McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction
Why was McGhan BioDIMENSIONAL silicone-Filled Breast Implants recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ALL LOTS;
- Product
- McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction
- Recalling firm
- Allergan PLC
- Quantity
- 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.
- Recall date
- September 18, 2019
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)