Allergan Breast Implant Recall and Update

Allergan BIOCELL textured breast implant recall

In respone to rising numbers of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) patients throughout the world, the FDA issued a press release on July 24, 2019 requesting that Allergan recall their BIOCELL© textured saline and silicone breast implants in the United States.  The FDA press release has current information on BIA-ALCL within its press release and you can read it here.  You can see a short video of me explaining it here.

ALCL is a rare cancer that has a propensity to arise from the capsule around certain textured saline and silicone breast implants.  The vast majoriy of these implants are coarsely textured implants (macrotextured, or Grade 3 and 4 texturing).  To date there has been no known case associated with only smooth implants.  The implants of concern in the United States have been the Allergan implants with their proprietary BIOCELL© texturing.  These include textured implants manufactured under the brands McGhan, Inamed, or Allergan Natrelle.

The FDA recall was only directed at implants that had been distributed but not implants already implanted.  For asymptomatic women with these implants, there has not been a recommendation for prophylactic removal of these implants given the rarity of BIA-ALCL.  

On July 30, 2019, Allergan annnounced the BIOCELL© Replacement Warranty for all patients currently implanted with BIOCELL© textured implants.  Allergan will provide smooth breast implant replacements for free, however will not cover the associated costs of the surgery.  The program will run until July 24, 2021.

Although I have used Allergan's smooth saline and silicone implants, I never used BIOCELL© textured implants as I never liked the coarse texturing, for a number of reasons (long before we knew about BIA-ALCL).  There may have been a few exceptions years ago if I placed them for a warranty replacement of a previous BIOCELL© implant, or at patient's request. 

For silicone implants, I prefer Sientra implants.  Their textured (microtextured, Grade 2 texturing) implants seem to have had only a few cases of BIA-ALCL worldwide.  Their capsular contracture rate, rupture rate, and warranty are the best as well.

Contact your surgeon if you are interested in replacing your Allergan textured implants, regardless if you are interested in taking advantage of the BIOCELL© Replacement Warranty or not.  If you are unsure you have Allergan textured implants, look at the card you were given after your surgery, it has all the information you need.  (You did keep that card, didn't you?  See my post on that here). 

If your surgery was years ago, your card might say McGhan or Inamed.  Style 410 anatomical silicone or Style 168 saline are examples of BIOCELL© implants.  You can ask your surgeon to look at your operative report, but if it was more than 10 years ago your record may not be available.  If it was that long ago you might want to think about replacement anyway.  And you have had the recommended MRIs of your silicone implants haven't you?

Douglas J. Mackenzie, MD

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