Visage Clinic: Dr. Marc DuPéré
101-133 Hazelton Avenue
Toronto, ON M5R 0A6
Phone: (416) 929-9800
Fax: (416) 368-3113
Toll Free: 1 (855) 8 VISAGE
Monday-Friday: 8:00 a.m.–5:00 p.m.

Textured Breast Implants Recall & BIA-ALCL: What You Need to Know

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BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is a relatively new condition that recently came up in the news and over social media. It is also relatively new to plastic surgeons. I want to emphasize this for women considering breast augmentation with implants at my Toronto plastic surgery practice: BIA-ALCL affects ONLY TEXTURED implants. Smooth silicone implants are safe.

Of all textured (roughened surface) breast implants available in Canada, Allergan’s Biocell implants have the highest rate and Health Canada have pulled them out of the market.

Allergan’s Response

Yet the risk of ALCL is very low and because of that, Health Canada and the U.S. equivalent, FDA, do not recommend the systematic removal of asymptomatic textured implants as everyone feels the risk of surgery exceeds the very low risk of developing ALCL. Despite this and in view of many patients feeling concerned about their asymptomatic textured implants, Allergan announced on August 5th, 2019, that it would offer new smooth breast implants to patients should a patient want the prophylactic (preventative) removal of her textured implants.  Allergan will replace the implants for the exact size and will not cover the other fees related to surgery. Obviously, proper discussion of the pros and cons and possible complications will need to be discussed with your surgeon, as with any other types of surgery.

What Is BIA-ALCL?

ALCL unrelated to breast implants has been known before but the textured breast implant-related, BIA-ALCL, is a very rare type of lymphoma that arises in the capsule around textured breast implants. BIA-ALCL is not a cancer of the breast tissue itself. When diagnosed early, it is readily curable.

The first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average of about 8 years after implantation. This fluid can cause the breast to enlarge significantly over a period of days or weeks. It can also present as a lump in the breast or armpit, firmness of the breast, or pain.  It is usually easily and completely treated if patients see their doctor at the first symptom.  If the disease is advanced, chemotherapy or radiation may be required. BIA-ALCL can be diagnosed with a fluid aspiration and analysis for a marker, the CD30 marker.

As of July 24, 2019, the FDA reports that there have been 33 confirmed deaths in the entire world (with some countries not offering the same high standards of care Canada is offering), out of millions and millions of ladies with breast implants. Yet, BIA-ALCL is a highly treatable disease with high cure rates when caught early.

Why Do Textured Implants Cause BIA-ALCL?

Texturization was designed to make the implants “more sticky” and to delay or prevent sagginess of the implants over time. It is hypothesized that bacteria may be the responsible for inducing this mechanism, hence the importance today to use the “no-touch” technique I use when performing breast augmentation surgery in Toronto (it may also decrease the risk of capsular contracture). Another theory would involve the micro-pieces of textured implants which may flake off and might elicit a chronic inflammatory reaction and, in a “genetically susceptible” individual, may lead to a neoplastic (cancer) process. I say “genetically susceptible” as there are many more cases per implanted ladies in Australia than in Brazil, for example (unless there is under-detection and/or under-reporting in Brazil to date). However, it is common for cancers to be genetically related.

Not all texturization is created equal, as each company owns a trademark and protected industrial process to obtain this roughened surface. Although BIA – ALCL has been seen in all types of textured implants in the world (Canada has 3 breast implant manufacturers but there are more companies around the world), the Biocell textured Allergan implants have the highest number of ALCL cases in Canada, hence Health Canada pulled Allergan’s textured implants from the Canadian market back in May 2019, as did France, England and many other countries.

Again, Health Canada does not recommend the systematic explantation of textured breast implants yet Allergan has recently announced it would cover the cost of smooth implants to women interested in the removal of their textured implants. Should any implanted patient be concerned, she should visit a plastic surgeon for an assessment and discussion.  Having the information on her implants would be very useful.

If you would like to learn more about BIA-ALCL or other breast augmentation considerations, please contact us online or call my Toronto practice at (416) 929-9800.

Dr. Marc DuPéré

 

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