Breast Implant Illness (BII)

Breast Implant Illness

An Entry Point and Center of Excellence

The office of James J Romano MD


Dr Romano offers an entry point and center of excellence for women with breast implant related issues. This involves education, imaging, examination, testing, surgery, pathology analysis and follow up. His patients think of this as a complete “breast implant check-up”.

This section written by Dr Romano for the purpose of sharing more detail about the science and research related to Breast Implant Illness. The association between breast implants and systemic disease has been reported beginning in the 1960’s. Although the research and understanding of this condition has evolved greatly over these years and many studies have looked at supporting or refuting the existence of BII, the issue remains, and research is rapidly evolving in this condition now called “breast implant illness”. The term BII has been loosely applied to very broadly encompass all complications related to silicone breast implants. You can see the challenge here.


The concept of BII began early on dating back to the 1960’s with the newly described condition to be called “’human adjuvant disease”. This is defined as where foreign substances, here silicone, present or injected into the body creates an immune response, usually some sort of collagen vascular disease. In the 1990’s concerns built regarding a potential association between silicone and autoimmune or rheumatic diseases, and the FDA issued a moratorium that severely limited use of silicone breast implants. As the number of women with implants has grown, so has the number of effected patients, and thus, so has the recognition and study of this disease. Next came the discovery of the role of bacteria as a causative factor, where bacteria embeds in the breast capsule. This is the biofilm phenomena. Finally, more recently, although there has even been growing evidence of the association of implants with BIA ALCL, this has not been found to be associated with BII, but research continues in this area. All these conditions are related to silicone implants regardless of implant type, manufacturer, surface or filler.


Just as you are reading this blog, understand the benefit of social media in bringing all of this into a clearer light. The resultant beneficial surge in the social media attention to this condition has served to collect more effected patients into groups, educate, and better define patient expectations and symptoms. Going one great step further, it has facilitated (through data collection) more research based on a larger sample population. Still, no evidence of association between breast implant and a significant increase in the summary-adjusted relative risk of individual connective tissue and autoimmune disease can be demonstrated. Studies are inconclusive but there is no denying the number of women that present who are distressed by their implants and want them removed. Furthermore, there is no denying how many women have been cured by removal of implants. There are “outcome studies” which have given us some information and now documented there is a statistically significant improvement in subjective health for patients distressed by their implants.


With all of this, even now, BII is a poorly characterized cluster of nonspecific symptoms mostly defined by patients. The explosion of information and groups on mainstream media and social media has fueled a growing awareness and, in fact, an accumulation and identification of symptoms available to researchers. Because many women self-diagnose this condition, they can present to doctors for evaluation and treatment. Most are requesting removal of implants.

The diagnosis of BII is the challenging part but it does not have to be. First consider that these symptoms (and more on Facebook) have been associated with BII:

  • Brain fog, memory loss, vertigo, headaches, migraines, tinnitus,
  • Muscle/joint pain, sore and aching joints, numbness/tingling in upper and lower limbs, fibromyalgia, neuralgia/burning pain, discoloration of hands/feet, slow muscle recovery after activity
  • Autoimmune disease – Raynauds, Hashimotos, RA, sclerodermal, SLE, Sjogrens, MCTD, MS, recurrent infections, toxic shock, fevers night sweats, slow healing and easy bruising, chronic fatigue, persistent infections, sudden food intolerance and allergies, tender lymph nodes
  • Frequent urination, liver and kidney problems, reduced libido, UTI, reflux, gastritis, weight loss/ gain, sudden dehydration, liver dysfunction, leaky gut, IBS, metallic tastes, choking, difficulty swallowing, pancreatitis, gallbladder disease
  • Hair loss, dry skin, dry hair, skin rashes
  • Anxiety, depression, panic attacks, feeling of impending death
    Shortness of breath, heart palpitations, arrhythmia, heart pain, cough, throat clearing RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; MCTD, mixed connective tissue disease; MS, multiple sclerosis; UTI, urinary tract infection; IBS, irritable bowel syndrome.

In one study he 9 most common symptoms reported by the 44 patients were in order: fatigue, arthralgia, brain fog, myalgia, memory loss, difficulty concentrating, autoimmune diagnosis, rash, and visual disturbance/dry eyes.

The symptoms are a guide but not an absolute determinant to the removal of implants. If you want them out and have no symptoms, then Dr Romano will do this for your and educate and direct you through the process.


Consider first that there is no known pathophysiological explanation or cause and effect or diagnostic testing specific for BII. If patients agree, there may be a role for certain testing because we know from other conditions there exists an inflammatory-driven exaggeration of the immune response that can produce fibrosis, autoimmune disease, and lymphoma—all the same noted adverse outcomes following breast implant surgery. There is a number of blood tests screening for autoimmune disorder markers included but not limited to:

  • Complete blood count
  • Urea, electrolytes, creatinine
  • Liver function tests
  • Thyroid function
  • CRP, ESR
  • Serum IgG, IgM
  • Iron, ferritin
  • Autoimmune disease markers (16 or more of these)


Treatment will depend on symptoms and physical exam but, most importantly, will address patient desires and expectations. In other words, if you want the implants out, we do this. A thoughtful and systematic assessment will involve:

  1. Your fundamental concerns and expectations. This is the most important and not ignored.
  2. Your implant history
  3. History of your illness
  4. Record of your symptoms
  5. Testing, imaging, and evaluation of the results
  6. Physical exam

The options then become:

  1. Do nothing. This can be a very good option. Here you are educated about the results of evaluation and testing and are relieved to be able to pursue a safety plan of follow-up.
  2. Revise implants with total capsulectomy. At times, patients do not want to have implants removed but choose to remove what can be the offending agent, the capsule, and put in new implants.
  3. Remove implants completely. Dr Romano performs a complete and total capsulectomy in all patients. Be aware that many doctors only remove the implants or remove only part of the capsule. Depending on your anatomy, removal may be all that is indicated, and your cosmetic result will be very satisfactory. See the photos in this section.
  4. This involves lifting of the breast (mastopexy) or fat grafting or both. This can be done at the same time as breast implant removal or delayed until a later date. You never burn any bridges doing this in two stages, often it is a better choice.

Surgery is virtually always performed as an outpatient. It is in a highly credentialled and certified outpatient surgery facility where there is no ICU or ER or any exposure to COVID. General anesthesia is utilized, and a very experienced anesthesiologist will administer this under Dr Romano’s watchful eye. Procedure is usually about 2 hours, maybe more. These is minimal or no pain postoperatively. You can resume most activities the next day and work soon after.


At the time of surgery, the capsule is completely removed. It is sent for studies of the microbiological and histological markers of immune related disease. We are looking for immune phonotypes and toxicology markers as well. There is much study in this area and hopefully this can shed some light on what symptoms may be related to breast implants or not, and the chance of cure.

Studies have clearly defined that removal of implants and capsulectomy significantly reduces symptoms. Studies have concluded at least half of patients get better. Studies have demonstrated both an immediate and sustained improvement across a number of common symptoms.


This is important and Dr Romano is organized and thorough about this. We will review the results of your capsule examination. You will want to track your symptom progress. You may want to track your laboratory tests and their improvement as it relates to your symptoms. Importantly, you will want to track your cosmetic result. Lastly, Dr Romano will be on the cutting edge of any evolving research, so you will want to be educated on this.

For more details on the above and any peer review journal references, please call or visit the office of Dr. James Romano. 415-981-3911.