Explant & Breast Implant Illness — BII

Breast Implant Illness (BII) is a term that originated from a group of women who became ill after undergoing a breast augmentation.  This illness is a set of symptoms attributed to breast implants and they might vary from patient to patient and affect them in different ways. These symptoms are all related to autoimmunity and are also present in many autoimmune conditions.

The first thing that needs to be cleared is that there are still many unanswered questions regarding the physio-pathology and etiology of this condition and although several theories have being proposed there is still not a clear understanding of why some women are developing these set of symptoms.

The Adjuvant theory

A breast implant is a foreign body that for years the medical community thought was very biocompatible with the human body.  Though some patients were developing capsular contractions, which is a clear proof of the body reaction to the implant, the medical community continued to feel these devices were safe.

An adjuvant is a particle that stimulates the immune response to a foreign body — or what is called an antigen. There is a good possibility that the implants might contain substances that are acting as adjuvants, which in some women are triggering a chronic immunological systemic response, i.e. an inflammatory response, that induces the immune system to attack different tissues of the body.  These foreign bodies are seen by the immune system as antigens and in turn cause the symptoms suffered by these patients.

There are many substances that can behave as adjuvants.  Multiple articles have being published proposing that some of those present in breast implants might cause autoimmunity and this possibility was overlooked years ago with the studies that cleared breast implants for safe use.

The first suggestion of this problem was described 50 years ago as a syndrome called adjuvant breast disease.   In my practice I have placed hundreds of breast implants over the last ten years with excellent results and high satisfaction rates, but I believe that a small percentage of patients have some type of predisposition for developing an autoimmune like response to breast implants that has being recently denominated Breast Implant Illness (BII).  I believe that this doesn’t only happens with breast implants, but adjuvants present in some vaccines, some infections, such as Lyme’s disease, some proteins in food and even some metals are capable of arising and exacerbate an immune response resulting in very similar syndromes that have being described with almost identical symptomatology. These include amongst others, the ASIA syndrome and silicone incompatibility syndrome.  Autoimmune Syndrome Induced by Adjuvants, known as ASIA syndrome, refers to autoimmune syndromes induced by adjuvants.

The etiology of autoimmune syndromes, such as Fibromyalgia, Schoegren’s, Systemic Erythematous Lupus, Rheumatoid arthritis, chronic fatigue syndrome, etc. have been categorized as idiopathic, which is the medical word used for “We just  don’t know the cause”.

We know that some autoantibodies and some inflammation proteins turn positive, but the reality is that we don’t know why.    It appears that one day our immune system decides to start fighting our own body.  It is very interesting to observe how some of these syndromes have such similar onsets and symptoms.   It is hard not to wonder if they could potentially be triggered by adjuvants, just like it is happening to some people with vaccines, silicone implants and some infectious diseases.

The symptomatology includes many different physical signs, but all of them are linked to some sort of inflammation affecting different systems and tissues in our bodies.  Dr. Yehuda Shoenfeld published in his ASIA syndrome article that removal of the “inciting agent” helps with improvement.  This fact is consistent with the Maastricht cohort study where improvement of complaints occurred in 50 % of the patients and in another study, conducted by Peters, where patients experienced 58 % improvement after explantation, and 74 % of the patients declared that they “felt better and that their quality of life had improved”.  We don’t have the information on whether the capsules were completely removed or not, but in the past it has not been a common practice to completely remove the capsules.

In our ongoing study with more than 130 patients with Enbloc explantations (implant and biological capsule surrounding the implant completely removed) the percentage of full remission of symptoms at 6 months is 75% and improvement of symptoms is 85%,

The difference in outcome might be due to the fact that the capsules surrounding the implants were fully removed.   The tissue analysis by pathologists hase proven that many implants have groups of macrophages with clear inclusions in cytoplasm, which corresponds to silicone leaks, even if their shells are unbroken (Figure 1 Foamy Hystiocytes).  We also found some patients who had silicone particles in their axillary lymph nodes and in some that have tested positive for silicone particles systemically, could potentially account for the patients not experiencing remission or improvement, even if an Enbloc resection was correctly performed.

It is very hard to know if these patients are not also experiencing these problems due to another adjuvant present in their bodies and it is still unclear why some patients develop the problem and others don’t just like it happens with autoimmune diseases.

Important concepts TO KEEP IN MIND:

  1. Not everyone who has a breast implant will develop Breast Implant Illness (BII). There are many patients that have gone years with the implants without developing any symptoms, thus we think there has to be an immunological predisposition to developing ASIA/BII just like with autoimmune syndromes.
  2. I consider it is very important to generate awareness in the medical community that the possibility of women developing these symptoms is real, since most of the patients with the problem, are being ignored by their physicians. My patients comment that it is very frustrating to consult with doctors who don’t take them seriously.
  3. I consider it very important to advise patients requesting a breast augmentation for aesthetic or reconstructive purposes that just like there is a possible correlation between the ALCL and the breast implants, there could be a possibility that they develop a BII. They should both be mentioned as possible risks. PRIOR TO CONSENTING TO A BREAST AUGMENTATION.
  4. I think it is EXTREMELY important to perform a full removal of the capsule and not only the breast implants, since the particles that work as adjuvants can stay in the capsule and continue to trigger the immunological chronic stimulus.
  5. I believe BII is currently underdiagnosed due to the unawareness of the medical community and many women are being treated for autoimmune type syndromes, depression etc. not realizing there is a real BII syndrome behind.
 

We are currently developing a controlled research study to corroborate the epidemiological correlation between BII and breast implants which aims to prove the immunological mechanism of action that produces the breast implant illness syndrome.

Explant

Explant 

A total capsulectomy will be performed if an en bloc resection cannot be accomplished. Your capsule may contain bacteria or silicone pieces that should not be left in your body.

Your implants will be returned to you in a sealed medical bag. Pack these in your luggage and not your carry-on for your return flight home.

Explantation can be performed with or without lift.

Many patients will need a breast lift at the time of explant due to the increased sagging of their breasts when the implants are removed. However, you may not need a breast lift in a few instances. You may not need a breast lift if you have small implants and/or good skin elasticity. 

What is an en bloc resection?

When the implant is contained inside a capsule, the body forms around it, an enbloc means the implant and the tissue around it are removed together as a single piece. It is challenging to perform, especially when separating the capsule from the thoracic wall when the implants are under the muscle. The capsule tends to adhere to the ribs and intercostal muscles close to the lungs. Adequate Enbloc resection requires a surgeon with experience in the procedure and thorax wall reconstruction.

 

Why is an Enbloc resection important in breast implant illness?

Dr. Urzola believes that by continuity, many of the adjuvants contained in the breast implants could potentially stay in the biological capsule generated by the body around the breast implant. Failure to fully remove this capsule could perpetuate the exacerbated immunological response in these patients.

What is Total Capsulectomy?

Total Capsulectomy is when the surgeon removes 100% of the capsule that is in the body, in the chest cavity.

Why do some doctors not believe breast implant illness is actual?

This is simple. Currently, the scientific evidence that breast implants make women sick is insufficient. The symptoms experienced by patients with BII are varied. Some patients experience symptoms that are different from others.

Suppose you are not well informed about these various presentations. It is easy to misdiagnose the problem or blame these symptoms on depression, fibromyalgia, some other medical condition, or worse, to assume that there’s nothing wrong.

Dr. Urzola has heard your concerns. He and his team are committed to researching this matter further due to the critical reported improvement in the health of over 1000 patients after their implant removal.

Do breast implants make everyone sick?

This is probably one of the most frequently asked questions. If I answered it with a yes or no, I would say no. Many patients don’t seem to have any problems with their breast implants and have had them without developing any symptoms. Still, by the same token, just like with a capsular contraction, we don’t know if they will eventually develop.

Symptoms