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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. 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

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