Biocell Breast Implant & Tissue Expander Recall [US]


US FlagUS/Silver Spring: Logo - Allergan AestheticsAllergan Aesthetics, an Irvine, California establishment and subsidiary of AbbVie of North Chicago, Illinois, recalls an estimated 52,000 Biocell Breast Implants and/or Tissue Expanders from the American marketplace due to suspected risk of Breast Implant Associated Anaplastic Large Cell Lymphoma (“BIA-ALCL”), a type of Non-Hodgkin’s Lymphoma (Cancer of the Immune System) and consequential risk of possible life-changing complications, all serious health hazards.

FDA: http://ht.ly/j7Bw30qN5k9

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-aesthetics-launches-dedicated-multi-channel-campaign-contact-patients-who-may-not-be-aware

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Breast Implants and/or Tissue Expanders are subject to this recall:

  • Biocell Breast Implants and/or Tissue Expanders, as follows:
    • Natrelle Saline Breast Implants
    • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
    • Mcghan Biodimensional Silicone-Filled Biocell Textured Breast Implants
    • Natrelle Inspira Silicone-Filled Breast Implants
    • Natrelle Silicone-Filled Breast Implants
    • Natrelle 133 Tissue Expanders with and without Suture Tabs Style 133 Biospan Tissue Expander
    • McGhan Magna-Site Tissue Expander
    • Natrelle 133 Plus Tissue Expanders
    • Mcghan Style 134 Croissant Shaped Tissue Expander

You can see see the complete list of products with affected product styles here:
https://www.Biocellinformation.com/~/link.aspx?_id=3982E2A3BBCE4A398D493DDB39C40E70&_z=z

For countries other than the United States, please refer to the Allergan Global Medical Information Contacts here:

https://www.biocellinformation.com/~/media/allergan/documents/us/Products/Biocell/Global-Medical-Information-Contacts.pdf

==> No barcodes, DINs, UPCs, item numbers, best-before dates, regulatory approval designations or other identification numbers were listed with this recall notification.

According to the FDA, Allergan Aesthetics has initiated a new digital campaign to improve device tracking and further identify and reach Breast Implant patients who have, or have had, Biocell Breast Implants and/or Tissue Expanders to inform them of the risk of BIA-ALCL. Since July 2019 when the Biocell recall was announced, “robust efforts” were made to reach patients, however, the Company is still seeking to directly contact all US Biocell patients that have not yet been notified. This is due to incomplete device tracking data for approximately 52,000 Biocell Breast Implant units.

==> Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (“BIA-ALCL”), please visit the FDA site here:

https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl

It is important to note the United States Food and Drug Administration has made the following recommendation, “If you have no symptoms, we are not recommending the removal of these or other types of Breast Implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider.”

If you believe you have any of the recalled Breast Implants or Tissue Expanders, please consult your physician.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat Non-Hodgkin’s Lymphoma.

If you have any further questions, comments or complaints about this recall, please visit to https://www.biocellinformation.com to reach out to Allergan Aesthetics to determine if the company has your implant information. You can also contact the company US Customer Relations and Medical Affairs Department toll-free at 1-800-678-1605.

==> To see other recalls and notifications caused by faulty Breast Implants or Tissue Expanders, please search for “medical devices” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Allergan Aesthetics, please search for “Allergan” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Biocell brand name, please search for “Biocell” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 13101-2020
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
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General information:
More recalls? Back to the main Recalls Direct page:
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Visit the Living Safely site:
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==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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