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Class 1 Device Recall Natrelle SiliconeFilled Breast Implant |
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| Date Initiated by Firm |
July 24, 2019 |
| Date Posted |
September 11, 2019 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2454-2019 |
| Recall Event ID |
83500 |
| PMA Number |
P020056 |
| Product Classification |
Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR
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| Product |
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers:
Style 110:110-090,
110-120,
110-150,
110-180,
110-210,
110-240,
110-270,
110-300,
110-330,
110-360,
110-390,
110-420,
110-450,
110-480,
110-510;
Style 115 :115-150,
115-167,
115-185,
115-203,
115-222,
115-253,
115-272,
115-290,
115-322,
115-354,
115-378,
115-401,
115-435,
115-469,
115-507,
115-547,
115-586,
115-627,
115-666,
115-716;
Style 120: 120-180,
120-220,
120-260,
120-300,
120-340,
120-400,
120-440,
120-500,
120-550,
120-600,
120-650;
These products may have been sold under the McGhan, Inamed or NATRELLE brands.
Product Usage: Breast augmentation and Breast reconstruction |
| Code Information |
ALL LOTS Product Code/UDI STYLE 110:110-090 10888628002159, 110-120 10888628002166, 110-150 10888628002173, 110-180 10888628002180, 110-210 10888628002197, 110-240 10888628002203, 110-270 10888628002210, 110-300 10888628002227, 110-330 10888628002234, 110-360 10888628002241, 110-390 10888628002258, 110-420 10888628002265, 110-450 10888628002272, 110-480 10888628002289, 110-510 10888628002296; STYLE 115:115-150 10888628002302, 115-167 10888628002319, 115-185 10888628002326, 115-203 10888628002333, 115-222 10888628002340, 115-253 10888628002357, 115-272 10888628002364, 115-290 10888628002371, 115-322 10888628002388, 115-354 10888628002395, 115-378 10888628002401, 115-401 10888628002418, 115-435 10888628002425, 115-469 10888628002432, 115-507 10888628002449, 115-547 10888628002456, 115-586 10888628002463, 115-627 10888628002470, 115-666 10888628002487, 115-716 10888628002494; STYLE 120:120-180 10888628002500, 120-220 10888628002517, 120-260 10888628002524, 120-300 10888628002531, 120-340 10888628002548, 120-400 10888628002555, 120-440 10888628002562, 120-500 10888628002579, 120-550 10888628002586, 120-600 10888628002593, 120-650 10888628002609; |
Recalling Firm/
Manufacturer |
Allergan PLC
2525 Dupont Dr
Irvine CA 92612-1531
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| For Additional Information Contact |
Nicole Katz
714-246-4500
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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.
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FDA Determined
Cause 2 |
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
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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.
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| PMA Database |
PMAs with Product Code = FTR and Original Applicant = Allergan
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