BIOCELL® Product Safety Alert
Important Product Safety Alert of BIOCELL® Textured Breast Implants and Tissue Expanders
On July 24, 2019, Allergan announced a voluntary worldwide withdrawal of unused stock of BIOCELL® textured breast implants and tissue expanders from doctors’ offices and hospitals, and a suspension of any future sales which is part of the voluntary recall of BIOCELL® textured breast implants and tissue expanders. Natrelle smooth breast implants and MICROCELL® breast implants are not subject to this withdrawal.
Download the Patient Letter dated August 9, 2019 here
Why did we do this?
We took this action following notification by the U.S. Food and Drug Administration (FDA) of their recently updated global safety information. This information showed an association between breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and Allergan BIOCELL® textured breast implants. Read the full news release.
At this time, the likelihood of developing BIA-ALCL is thought to be low, occurring in less than 0.03% of patients with BIOCELL® textured breast implants. However, BIA-ALCL is a serious condition and can lead to death, especially if not diagnosed early or treated promptly.
Learn more by visiting the BIA-ALCL page.
What are BIOCELL® textured implants and tissue expanders?
BIOCELL® is the trade name of Allergan’s texturing process. Texturing on breast implants creates a rough surface as opposed to a smooth surface. Textured breast implants may be selected for a variety of reasons including to reduce the risk of capsular contracture, to help minimize implant movement and several others.
What is a “voluntary recall”?
This means that Allergan, the manufacturer, has willingly agreed to no longer make or sell these types of implants, and will retrieve the product from healthcare professionals. This product withdrawal from the market does not mean your implants need to be removed unless you have specific symptoms. Only unused products that are currently at doctor’s offices, hospitals, or surgery centers need to be returned.
It is important to note that the US Food and Drug Administration (FDA) as well as international regulatory agencies do not recommend removal or replacement of textured breast implants or tissue expanders in patients without symptoms.
BIA-ALCL symptoms include breast enlargement or hardening, persistent pain, lump in the breast or armpit, or a large fluid collection surrounding an implant. These symptoms have been reported between 6 months and 26 years after implant placement, and are typically diagnosed an average of 7 to 9 years after implant placement. BIA-ALCL is highly curable if detected early. Prompt diagnosis is key. Learn what is covered in your product warranty:
US Warranty Information
International Warranty Information
What Products are Affected?
Click here for the list of U.S. affected products.
Contact your local Allergan Medical Information Contact for information on affected products in countries outside of the U.S. Please refer to the Allergan Global Medical Information Contacts list.
These products may have been sold under the brands McGHAN, INAMED, or Allergan Natrelle®.
This global withdrawal does not affect Allergan’s Natrelle® smooth or Microcell® breast implants and tissue expanders. Natrelle® smooth breast implants and tissue expanders continue to be available to plastic surgeons and for patients.
Whom Do I Contact if I have Questions?
Click here to register your implants and contact us.
This site will be updated as new information becomes available.