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Today, Allergan® voluntarily withdrew all BioCell® Textured Breast Implants and Tissue Expanders from the world markets due to an association with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Allergan Biocell textured breast implants

Allergan® Biocell® textured breast implants have the highest association of BIA-ALCL.

Textured Breast Implants and BIA-ALCL

I have been posting about an association of BIA-ALCL and textured breast implants for some time here on the San Francisco Plastic Surgery Blog. While many types of textured breast implants exist, a higher association of BIA-ALCL has been found with more aggressively textured breast implants. Allegan® has the most aggressively textured breast implants and thus the highest association with BIA-ALCL.

BioCell® Textured Breast Implants and BIA-ALCL

BioCell® textured surface (shell) is a unique surface used only by Allergan®. A detailed list of the specific BioCell® textured devices marketed in the U.S. that are recalled can be found at the end of this post.

The FDA’s analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan® textured breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan® textured breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.

The risk of BIA-ALCL with Allergan® BioCell® textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other U.S. manufacturers.

BIA-ALCL Is Not Breast Cancer

Early treatment is the key to the cure for BIA-ALCL as it is for any medical illness. When in doubt; check it out.

Early treatment is the key to the cure for BIA-ALCL as it is for any medical illness. When in doubt; check it out.

BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.


It is important to understand how rare the occurrence is and put the numbers into perspective. Literature indicates the current lifetime risk is about 1 in 20,000 patients with textured implants. BioCell® has a 7x to 8x greater incidence of BIA-ALCL compared to all other manufacturers’ textures, including Sientra® Texture and Mentor® Siltex. Geographic regions also reported variable risks including: Australia 1 in 3,345 for BioCell® and 1 in 86,029 for Siltex. In 2018, over 400,000 women underwent breast augmentation and reconstruction with implants in the U.S. Here are some comparative rates from the Sientra website:

FDA Is Not Recommending Removal Of Textured Implants

FDA Logo

To date, the FDA has not recommended removal of textured breast implants, including those with Allergan®‘s BioCell® texturing.

From the FDA website:

List of Affected BioCell® Products

Allergan® Natrelle Textured Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:

Allergan® Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. All the new Natrelle Inspira BioCell® textured breast implant style numbers start with “T”. If your Allergan® Natrelle Inspira breast implant style starts with “S”, they are smooth, and are not part of this withdrawal. The following are the textured styles:

Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046. All style 410 implants are BioCell® textured. The following are the textured styles:

Allergan® tissue expanders for the breast that have BIOCELL texturing originally cleared as:

What To Do?

If you don’t know what breast implants you have, find out. All my patients are given a card with their implant information to keep in a safe place. If your surgeon did not give you this information, or you can’t find it there are options. You can

90% of the breast implants used in the U.S. are smooth and are not affected by this action. In my office, we have always preferred the results obtained with smooth breast implants. Less than 1% of the implants I have placed are textured, and not all of them are Allergan®. In fact, in my over 20 years of practice, I have removed more textured breast implants than I have placed. If you had your breast augmentation with me, and are wondering which implants you have, your breast implant card should state whether your implants are smooth or textures. If you don’t have your card, just give us a call and we will look it up.

If you have Allergan® BioCell® textured breast implants, don’t panic. Your risk of developing BIA-ALCL is still very low. If you are asymptomatic, the current recommendation is to leave them alone, and monitor for changes. If you have changes, do not delay in getting evaluated by your doctor. The most common presentation is an increase in size of one breast years after breast augmentation, usually due to a collection of fluid around the breast implant (seroma). While, most seromas are not due to BIA-ALCL, all should be investigated. If you have any concerns, contact your plastic surgeon for more detailed information.

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