Breast Implant Illness

Breast implant illness (BII) refers to a group of symptoms experienced by some patients who have breast implants, which may or may not be relieved after implant removal. Since very little research has been done regarding BII, it is poorly understood by doctors and patients alike. Without independently funded, rigorous scientific studies to guide clinical decision-making, we are left with a range of opinions on how to approach and treat breast implant illness. 

The fact remains that women are having real symptoms that may be related to their implants. They want to be heard and they want treatment. 

For too long, patients with the symptoms of breast implant illness have been ignored and dismissed by the medical community. My goal is to listen, offer resources, and find the best possible treatment for every patient that comes to me with the symptoms of breast implant illness.

I am a data-driven surgeon. Good patient care is my #1 priority and what guides my practice. Without sound knowledge of the scientific basis of surgery, it is impossible to provide good patient care. But when we are working in a “data-free zone”, as with BII, we must get back to the basics. What do we know? What don’t we know? What is reasonable? What isn’t?

I would like to share my opinions and experience with BII, as well as the approach to treatment we offer at Halvorson Plastic Surgery. First and foremost, know that we will listen to you and offer a treatment plan that is built around YOU.

What Is Breast Implant Illness?

There is no formal, established definition of breast implant illness, and this is part of what has made studying this problem so difficult. Without a definition or diagnostic criteria, we cannot determine how prevalent BII is.  Patients have reported a large variety of symptoms, including but not limited to:

  • Fatigue
  • Memory loss (“brain fog”)
  • Rashes
  • Night sweats
  • Insomnia
  • Anxiety
  • Fibromyalgia
  • Auto-immune disorders
  • Connective tissue disorders

The symptoms are often hard to measure with tests, and they may take years to develop. In addition, they may take years to resolve after implant removal. As such, no one has a checklist or working definition of this problem and this is why some doctors won’t recognize BII, whereas others will work to study and define it.

What Causes Breast Implant Illness?

We have no idea what the pathophysiological mechanism might be behind BII. We can assume it is some immunological reaction to silicone, but we truly do not know. Silicone particles can be found in the lymph nodes after implantation of a silicone implant, yet this seems to have no impact on most patients. For other patients, the presence of silicone may trigger a host of emotional and physiological responses that affect them.

It is important to note that BII is seen with both silicone AND saline implants.  Both devices have a silicone shell.  Silicone implants are filled with a silicone gel and saline implants are filled with saline (salt water).  

Is Breast Implant Illness Real?

One thing is clear to me: breast implant illness is real. There are many patients who have symptoms related to their implants. These symptoms are highly variable and some patients prefer to live with them so they can maintain their implants. For others, symptoms are significant enough that they pursue surgical treatment. 

Patients who feel they have BII need to be taken seriously and their concerns and priorities should inform the surgical plan. Research is ongoing to define the best treatment. Some early data suggests that there is no difference in outcome between patients having no capsulectomy, total capsulectomy, or en-bloc capsulectomy.  Some studies have shown <50% improvement in patient symptoms with capsulectomy while other studies have shown >90% improvement.  The difficulty here is that there is no standard definition for what BII is and how researchers have measured outcomes is variable.  There are currently several ongoing well designed studies that should provide us with more information.  Unfortunately, it will likely be impossible to answer the question as to whether or not capsulectomy is required because so few patients would consent to surgery without capsulectomy.  Social media and the internet have amplified the concept that en-bloc or total capsulectomy is a necessary part of treatment (without data to support this fact conclusively).

We cannot promise that surgery will cure BII, and I tell patients there’s about a 50% chance it will significantly help relieve their symptoms, but we honestly do not know exactly how effective surgery is.  Patients who are willing to take these chances are clearly suffering from something real.

What Is An Implant Capsule?

Humans form scar tissue around any foreign object that penetrates our bodies. This is a basic protective mechanism and a wonder of nature. A breast implant is no exception – we should never pretend that nature intended it to be there! The scar your body makes around a breast implant is called a “capsule.” 

For the most part, capsules are thin, translucent and supple, and implants should feel soft.  However, capsules can thicken and contract, making the implant feel tight, hard, and painful.  This can just happen over time or it can be a reaction to bleeding, infection, or implant rupture.  It is clear that the body can react negatively to breast implants as evidenced by this phenomenon of “capsular contracture.” But is it possible that the body could react negatively in other ways? Could emotional, psychological, and other physical issues be a manifestation of silicone toxicity or the presence of an implant? While this seems to be the case for certain patients, the medical community is still figuring out diagnostic testing and treatment. 

Patients with BII can have what we consider normal, thin, “healthy” capsules or they can have thick, calcified, contracted capsules. They can have soft/mobile implants or hard/firm implants.  Insurance sometimes covers capsulectomy when there is painful capsular contracture, but they do not cover the procedure when the capsule is thin and supple and they do not recognize BII as a diagnosis or cover surgical procedures to treat it. 

Treatment For Breast Implant Illness

Is Surgery The Only Option?

Most patients are so unhappy that they are willing to undergo implant/capsule removal to see if it helps, but the truth is that some patients may see no benefit from surgery. Perhaps they didn’t follow through with a detoxification protocol, perhaps the implants weren’t the culprit – we don’t know.  The truth is that no surgery is 100% successful; no patient or surgeon would dispute this.  However, if your symptoms arose soon after implantation and are consistent with BII, then surgery could be your best option. 

What Is A Detox Protocol?

A detoxification protocol is a regimen designed to rid the body of toxins. It may comprise of dietary changes, supplements, cleanses, and so forth. Some patients follow detox protocols following implant removal, though it is unclear whether or not they help resolve symptoms. 

While I do not know for certain, it would make sense to me that if you are reacting to an implant that has been there for years, it could take years following implant removal for the symptoms to resolve and it could take years of following a detoxification protocol to make that happen.  We have no idea which detox protocol is most effective, and we don’t even know if they are effective at all. 

Most patients I see will wait several months after surgery to see if their symptoms improve, and then consider a detox protocol if they aren’t seeing improvement. Specific detox protocols may work for some patients better than others, and this is where laboratory tests, such as CRP and ESR, may help guide you.

What Is The Best Surgical Approach?

We truly do not know what the best approach is. There are no studies that compare the outcomes of different surgical procedures to determine which one is best in regards to breast implant illness. It is my opinion that capsulectomy should be considered when treating BII, though we currently have no data to indicate which type of capsulectomy is most effective 

During an “en-bloc capsulectomy”, the surgeon removes the implant with its surrounding capsule intact as one piece. “Total capsulectomy” involves removal of the implant and ALL of the surrounding capsule, but it may not be removed as a single unit. “Partial capsulectomy” is removal of some or most but not all of the capsule. 

There are no studies that have compared en-bloc capsulectomy to total or partial capsulectomy in the treatment of BII. In fact, there are no studies that compare implant removal alone to implant removal and capsulectomy for treatment of BII. While we know that complete removal of a severely calcified and contracted capsule is beneficial for healing, and it makes sense that removing such a capsule should be done when treating BII, we do not know if removal of an otherwise thin, supple, “normal” capsule is necessary when treating BII.  (I place quotations around the word normal because a capsule is your body’s reaction to something that isn’t normal).  

In other words, we do not know if symptoms of BII will improve with implant removal alone vs. implant removal and capsulectomy.  The fact is that we have no data on which to base our clinical decisions, and therefore any treatment recommendations are essentially opinions. What may be right for one patient may not be the best option for another.  Many websites promote the concept of en-bloc capsulectomy as the procedure of choice, however this is purely opinion. 

Capsules come in a variety of forms, and may impact the kind of approach needed. While en-bloc capsulectomy may make sense for a densely calcified and contracted capsule, it may not make sense for a thin, supple, translucent capsule that is adherent to muscle and blood vessels in a patient with small breasts and large implants who doesn’t want a 9cm incision. No one can tell you that any one technique is proven or that outcomes are better with en-bloc vs total capsulectomy.  We simply do not have any data yet to support this.

What is My Approach?

My approach is to consider what makes sense and what is reasonable for you, depending on your anatomy, situation, and goals as an individual patient. Despite the lack of data, I believe that if you are having surgery to treat BII it is reasonable to remove the capsule as well.  Some are committed to en-bloc capsulectomy based on their own research.  If such a patient has relatively large implants that are soft with thin capsules, then this surgery is more technically challenging and a larger incision is required.  En-bloc capsulectomy is much easier in a patient with relatively small implants that are severely contracted (it’s easier to remove thick/firm capsules than thin/supple ones).

I suspect that there is no difference between en-bloc and total capsulectomy for treating BII, because both accomplish the same thing: 100% removal of the implant and capsule.  The implant and capsule have usually been there for years, so having the capsule violated for 15 minutes during surgery, in my opinion, is unlikely to make a difference. It certainly allows the surgeon to use a smaller incision and shortens the procedure. This being said, if a patient is committed to en-bloc capsulectomy I am happy to do it but the scar involved will likely be longer.

The only situations in which I might not perform 100% capsule removal are:

  1. When critical structures, such as the thoracoacromial blood vessels, are visible under the capsule and removal would risk injury to those structures, or
  2. When the capsule is densely adherent to the chest wall and removal would risk injury to the lung. 

In these situations, a small fraction of the capsule might remain, but it is usually the thin type of capsule and I generously cauterize it to destroy the cells that form the lining of the capsule. The more calcified, contracted and thick a capsule is, the easier it actually is to remove, and I have always been able to remove 100% of the capsule in these cases.

Is Finding an “En-Bloc” or “BII” Surgeon Important?

Sadly, some plastic surgeons have taken advantage of the BII situation.  They recognize that these patients are often dismissed and seek specialized treatment.  They see that opinions are very strong and fairly rigid treatment protocols are being promoted on various websites.  And most BII patients can’t go through insurance because they don’t recognize BII as a diagnosis.  So what do these surgeons do?  They market themselves as “En-Bloc” or “BII” surgeons and essentially copy and paste the opinions and treatment protocols promoted by various BII websites to draw in cash paying customers.  I find this disingenuous.  

Let’s be clear: en-bloc capsulectomy, total capsulectomy, mastopexy, and any other additional procedures are basic plastic surgery procedures that ANY plastic surgeon is trained to perform.  There is nothing special or magical about en-bloc capsulectomy that requires specialized training, etc.  Every plastic surgeon is an “explant” surgeon. The most important thing is to find a surgeon who listens to you, who doesn’t dismiss you, and who you have a good connection with.  It is also important to find a plastic surgeon who is certified by the American Board of Plastic Surgeons.  

Is Muscle Repositioning Important? 

If you have had a submuscular breast augmentation, chances are that the pectoralis major muscle has retracted superiorly. In some cases, patients can notice some arm/shoulder weakness because of this. Repositioning the pectoralis major muscle is an attempt to return the lower part of the muscle back to its original position.

The big question is: does this make a difference?  If you haven’t noticed a significant change in arm/shoulder strength following breast augmentation, then you aren’t going to notice a difference if the muscle is repositioned. If you have, then muscle repositioning may help, but it is unlikely that function will return to 100% normal. 

It is important to note that while muscle positioning may be useful with regards to arm and shoulder strength, it is not relevant when it comes to reshaping the breast. There are many ways to reshape the breast after explant surgery, but mastopexy and fat grafting are the most common. Muscle repositioning has NO effect on the shape of the breast (despite what some plastic surgeons may advertise). 

Is It Okay to Rupture Saline Implants Prior to Explantation?

I have ruptured many saline implants in my career. I have never seen anything but crystal clear fluid come out. Nevertheless, there are reports of patients who had “floaters” or mold growing in their saline implants. Even if there is mold, we don’t know if rupturing the implant has any negative consequence because this has not been studied. I believe that in the vast majority of cases it is safe, but I leave it up to patients to decide for themselves. 

For many women, doing this is very helpful so they can see what things look like at “ground zero.” From there, they can make a much more informed decision about next steps they want to take.

How Can We Test For Breast Implant Illness?

There are no definitive tests to detect or diagnose breast implant illness. However, there is a series of preoperative and intraoperative tests that can be done to better understand the body’s processes and reaction to the implants.

What Preoperative Testing Should Be Done?

There are many tests that could be done to measure your body’s immunologic reaction to a foreign object like a breast implant. White blood cell count (WBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), antinuclear antibodies (ANA), and others are all “non-specific” markers of inflammation. In other words, they may tell you that there is inflammation going on in the body, but they don’t tell you exactly what the cause is. They are just signs of inflammation.  

These tests are not diagnostic for BII and do not change our management. Getting such tests before and after surgery may or may not confirm that you were having an inflammatory reaction to the implants, but they typically do not change surgical management. They may be helpful in monitoring your response to different detox protocols, but most patients can monitor this on their own because they are in tune with their bodies and know what their symptoms are. It doesn’t matter if your CRP improves after explantation/capsulectomy if you still have brain fog and migraines – it just tells you that you had some type of inflammation, surgery helped it, but it didn’t help your symptoms. You’d know that surgery didn’t help your symptoms without getting the tests.

I don’t think these blood tests are crucial when evaluating and treating BII, but some patients are curious about what these tests might show and how they might change with surgery, so we are happy to help you obtain and interpret such tests.

What Testing Should Be Done In Surgery?

Many different tests can be done during surgery, although they do not always help provide a clearer picture or affect further management. Patients may have their implants processed and returned to them, the capsule sent for pathological analysis, or perform culture swabs of the implant pocket and/or implant saline to test for aerobic, anaerobic, fungal, and/or acid-fast bacilli cultures.

I have sent hundreds of implants, capsules, and culture swabs for laboratory analysis and the pathology report has never shown anything other than scar tissue consistent with an implant capsule. I have also never seen a positive culture, although this can certainly happen. The pathology findings have never changed my management of a patient. 

For smooth surfaced implants, I do not think it is necessary to send the capsule to pathology, but am happy to do so if patients want this additional information. For textured implants, I do think it is reasonable to send the capsules to pathology just to make sure there is no breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), although this condition is exceedingly rare and almost always presents with a large fluid collection and/or mass.  

With respect to microbiology testing, I recommend testing implant fluid if it is not perfectly clear, or the implant pocket if there is any inflammation or sign of infection. In the absence of these findings, I have never seen a positive culture but that does not mean it can’t happen and we let patients decide for themselves which tests to get. There are unfortunately no evidence-based guidelines that tell us which tests to order, so we will build a plan based on your goals and preferences.  All of these tests have associated fees which you will know up front. 

What Does Halvorson Plastic Surgery Offer?

Our primary goal is to offer care that is honest, evidence-based, and patient-centered.  

Although there are no definitive tests for BII, we can order the following tests:

  • Preoperative Testing: MRI, Ultrasound, CBC, ESR, CRP, ANA
  • Intraoperative Testing: Pathologic analysis of capsule, microbiology culture (aerobic, anaerobic, mycobacterial, acid-fast bacilli), implants processed and returned

Surgery is performed in our office-based AAAASF-certified ambulatory surgery center with an MD anesthesiologist and experienced nursing and OR staff. Procedures offered include:

  • En-bloc capsulectomy
  • Total capsulectomy
  • Mastopexy
  • Fat grafting
  • Breast reduction

Post-operative care is included. We usually see our patients 1 week after surgery (or day after if they are traveling and speding the night in Asheville), 1 month later, and 3 months later. Recovery is generally 1-2 weeks out of work but you will not see the final result until at least 3 months.

Final Comments

I hope we will eventually establish a definition of breast implant illness and standardize testing to confirm the diagnosis. Hopefully this testing will allow us to better predict which patients will benefit from surgery. The American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) are working with plastic surgeons to organize the research studies required to help us define and treat BII. In the meantime, we are working in a “data-free” zone and must figure out what treatment options make sense for patients on an individual basis.

Everything I have discussed above is my opinion, based on 8 years of training, 15+ years in practice, and what little data we do have on breast implant illness. Without proper evidence, no one can claim that a particular treatment plan for BII is most effective. While I strongly believe that patient preferences should dictate how we approach surgery for BII, it is crucial for us to be honest about what is opinion and what is fact. It is my firm belief that breast implant illness is real; I have seen it cured by capsulectomy/explantation. I don’t think we have enough data to be rigid about what procedure is best, however, and I encourage patients to make informed decisions and consult with surgeons that they trust.

I hope the information I have shared helps you make decisions regarding your care that are based on facts, reason, and, most importantly, what makes sense to YOU.

Halvorson Plastic Surgery, Asheville

5 Livingston Street, Asheville, NC 28801 828-761-7499

Monday – Friday 8:30 a.m. – 5 p.m.