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Allergan Recalls Textured Breast Implants, What My Patients Need to Know

I am writing to share very important information to you about a type of breast implant that has been recalled.  Many of you have called and/or emailed with questions and I would like to proactively share my thoughts.

The type of implant involved is a textured breast implant.  This implant has been used for many years throughout the world.  In the United States surgeons have not used them as much as in Europe however there were many studies showing that in certain circumstances they were a better choice for patients.  For instance, many studies showed lower capsular contracture rates in patients receiving implants above the muscle.  In shaped, teardrop implants the texturing helped to keep the implants from rotating.

There are 3 main companies of implants in the United States, Allergan, Mentor, and Sientra.  Each company has textured implants.   Allergan’s texture is a more aggressive texturing and is the implant most at risk.  This is the implant that has been recalled.  Sientra and Mentor’s devices are still available.  All companies including Allergan continue to produce smooth implants.  

So, what is the issue?  The issue is a development of a rare type of lymphoma associated with breast implants.  Some of you have called or emailed with questions, and many  Around 2011 a newly described type of cancer, a lymphoma named Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) was discovered to be developing in some ladies with breast implants.  There was a clear association with implants, but data was very sparse.  It is important to understand that this is a very rare disease, and it has taken years to gather more data.

This is not a breast cancer, but rather a type of non-Hodgkin’s lymphoma, a cancer of the immune system.  In most cases the BIA-ALCL is found in the capsule (scar tissue) and fluid around the implant, but in rare cases can spread throughout the body.

The FDA has been very involved in gathering data about this disease.  The plastic surgery societies have also been extensively involved in not only educating plastic surgeons of what to look for, but also in providing information to registries and to the FDA so that we could learn more about this entity.

To date, there are 573 cases of ALCL known worldwide.  There are at least 12 deaths attributed to ALCL.  Considering that 400,000 augmentations are done in the United States alone annually, this is a very rare disease.  The risk rates at this point are unknown but are estimated to be between 1:3000 to 1:30000.  

In my practice I have used mostly smooth implants in the thousands of augmentations I have done.  That being said, I have certainly placed textured implants in select patients where I believe they would give a better result based on the scientific literature.  Some of these are Allergan implants and I would like to consult with these patients about their options.   

The FDA says people with these implants do not need to have them removed.  There is no data that removing the implant is necessary. That being said common sense says that if a device can cause a problem then maybe we should remove it and replace it with a safer implant.  I am happy to speak with all of my patients regarding this option.  It is a complicated discussion and we will need to discuss this on an individual basis.

Those of you with smooth implants have nothing to worry about at this time.  If you are unsure of your implant type call the office and we will look up your information.  We are going to conduct a review of patient charts in order to contact patients with textured implants however this will be a very paperwork intensive search that takes time.  

What are the symptoms of ALCL?  Anyone with implants should be aware:   ALCL usually presents with swelling of the breast years after surgery.  Patients notice a breast begins to swell and often hurts.  This usually occurs somewhere between 3 to 15 years after initial augmentation.  So, any unexplained swelling needs a visit to your plastic surgeon.  I am always happy to see any patient of mine experiencing such symptoms (and do not charge for the visit) but if you no longer live in the area you should seek evaluation by a board certified plastic surgeon.  Ultrasound imaging and biopsy is usually the recommended next step. 

The good news is that when caught early this is a very curable type of cancer.  Removal of the scar capsule is usually the only treatment needed.  Unfortunately cases that have had delayed diagnosis have led to deaths for ALCL spread.

Remember, this is a very rare disease.  It is associated predominantly with a specfic type of textured implant.  I am sending this email as there has been a significant amount of press surrounding this and I feel that my patients should be educated with good, factual information.  The FDA says that women with implants should continue enjoying them, and that they are very safe devices. 

Knowledge is power, and when this disease is caught early, it is highly curable.  Thus, if you ever have unexplained swelling please call for an appointment. 

If you have any questions, please do not hesitate to call the office and/or email me directly.  

As always,  Evan Sorokin MD