FB Pixel Skip to main content

As you undoubtedly already know, this past July Allergan voluntarily recalled all of its BIOCELL® textured surfaced breast implants and expanders as a precaution due to an extremely rare but real association with the development BIA-ALCL (breast implant associated anaplastic large cell lymphoma). Though this tumor has been associated with the textured surfaced implants of other manufacturers, their rates are about one sixth of Allergan’s BIOCELL® implants. None of these other manufacturers have taken their textured implants off the market. (For more information about this, you can refer to Important Information About Allergan’s Textured Surfaced Breast Implant Recall that I posted on July 31, 2019.)

Textured Surface Silicone Implant

Before we go any further, it is important that you understand the following:

• BIA-ALCL has NEVER developed in anyone who has only had smooth surfaced breast implants.
• BIA-ALCL has only developed in women who at some point in time, had textured surfaced implants.

What exactly does this recall by Allergan mean?

This recall simply means that all of Allergan’s BIOCELL® textured surfaced implants and tissue expanders that have been manufactured but not implanted yet are to be removed from the marketplace and sent back to Allergan. Nothing more.

It does NOT mean that anyone who has a BIOCELL® implant should or must have it removed.

ABSOLUTELY NOT!

The risks, etc. associated with removal of these implants FAR outweigh the extremely rare chance of developing BIA-ALCL.

This position is also supported by the FDA (Federal Drug Administration), the major plastic surgery societies and plastic surgeons.

Therefore, if you do have an Allergan textured surfaced implant, there is no strong reason to remove them unless you are having some sort of issues with them.

There will be those women who are concerned that they have these implants in their body and they definitely want to have them removed. Has Allergan addressed this issue?

Yes, they have, with their BIOCELL® Replacement Warranty which you can download from this page under US Warranty Information. Allergan will provide replacement smooth surfaced implants at no charge to patients. This includes all textured surfaced implants manufactured under the brands McGhan, Inamed, Allergan and Natrelle®. However, the company will not pay for any other associated surgical expenses in patients who are asymptomatic. Patients are also still covered under Allergan’s Natrelle® ConfidencePlus® Warranty.

As part of this Natrelle® ConfidencePlus® warranty is financial assistance of up to $1000 for late seroma diagnostic testing for the possibility of having BIA-ALCL. In addition, if you have been diagnosed with this disease, then there will be financial assistance of up to $7500 for the removal of the breast implant(s) and total capsulectomy.

The above is a brief summary of relevant information that is valid and in effect as of October 2019. Of course, this can/will change with time. For all the specifics (“fine print”), it is suggested that you thoroughly read both warranties. If you have additional questions on any of this, it is strongly recommended that you directly contact either Allergan or your plastic surgeon.

Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona

Request an Appointment

A Message Regarding Coronavirus/COVID-19

In light of the coronavirus/COVID-19 pandemic, we would like to let you know of some of the major precautions we are taking in our office to maximize cleanliness and keep the environment as sanitary and safe as possible. Our highest priority is always to ensure the safety of every individual who sees us and we are taking extreme infection-control measures to maintain cleanliness and “sterility” of surfaces and the overall environment.

We will be limiting dates and times for office appointments and consultations due to safety and other issues. Consequently, if you have already made an office appointment or consultation prior to March 18, 2020 to occur at a later time, this may need to be changed.

For anyone considering plastic surgery, we are now offering Virtual Consultations and Telemedicine through Skype. A great number of aesthetic or insurance-related issues can be evaluated via pictures and online video conferencing, making this an excellent way to find out more about particular procedures, determine candidacy for treatment, receive answers to questions and facilitate being able to move forward with care once the government lifts all restrictions.

In an abundance of caution, we are asking all current patients who are experiencing a fever, cough, chills, fatigue or any type of respiratory illness to please delay any upcoming appointments at our practice. We can talk with you by phone or email to establish a new date and time for the appointment.

We are all in this together. Our team urges everyone to follow the guidelines recommended by local health authorities and the Centers for Disease Control and Prevention, which include frequent handwashing for a minimum of 20 seconds, social distancing, staying home if you are feeling sick, and contacting your healthcare provider if you feel you are experiencing symptoms.

For more information, please read our blog – Coronavirus and You: Important Information

For further updates, please check our blog.

If you have any questions or concerns, please contact us by phone or email.