Breast Implant Illness

Who is likely to Respond to Implant Removal?

There is no single definitive test for patients who suspect their breast implants are effecting their health. The reason to consider blood test is that many of the symptoms attributed to BII can be associated with other treatable diseases and syndromes.

Patients tend to fall into several categories. Those who have totally normal blood test profiles, that do not point to any particular disease often respond to implant removal. This appears more predictable when the symptoms do not seem to match up with known diseases (for example, joint issues that would be atypical for osteoarthritis or Rheumatoid, cardiac symptoms in age/healthy individual without family history, multiple doctor visits to specialist without resolution or identification of a disease identification.)

There are patients who may have inflammatory markers such as positive ANA, elevated ferritin, CRP, and ESR, who are considered possibly on the path to developing an autoimmune syndrome but are not considered “declared” as of yet. Seronegative disease means you do not test positive but have symptoms and may have physical findings of the disease. These patients may have some resolution of symptoms, or may develop some recurrence in the future related to their condition.

Patients who have preexisting autoimmune conditions, defined endocrine disorders, and other specific findings may see improvent but not often full resolution of symptoms. Patients however have reported that they were able to reduce or eliminate some treatments after implant removal including Thyroid replacement medications, which would not be predictable preoperatively.

How is Breast Implant Illness treated?

Breast implant removal for many patients is an effective treatment and may resolve the symptoms in many women. Breast implant removal is also referred to as explant surgery or breast implant extraction. Plastic surgeons trained in augmentation should have experience and training in removal, revisions, capsulectomies, and other breast procedures. As with any procedure, you should select your surgeon for this operation based on their knowledge, skill, experience, and outcomes.

Breast explant surgery is commonly performed through an incision along the breast fold (the inframammary crease). The most technical aspects of the surgery are removal of the capsule (lining around the implant) and the approach to restoration of the breast soft tissue. Dr. Rudderman’s goal is to facilitate the most minimal impact on your tissue during surgery to enable the best conditions for healing and aesthetic outcome.

Implant removal surgery performed with any approach to the capsule, thick and calcified, or millimeter thin, should be approached to preserve and protect surrounding normal muscle, bone, cartilage, and soft tissue.

If you have experienced what you believe to be symptoms of BII and have felt dismissed by other surgeons or healthcare providers, you are not alone. Many women come to our offices feeling frustrated or even depressed because their concerns have not been heard with no diagnosis made and without discussion or treatment considerations. We are here to listen and to help you find relief from your symptoms. Patients have symptoms that are real, and a high percentage report improvement or resolution after implant removal.

We also understand that the decision to take out implants is not often an easy one, especially when no one else can ensure the procedure will alleviate your symptoms. Often women will describe resolution of other symptoms following surgery that they had not associated with BII preoperatively. While it is not possible to accurately predict if the removal of implants alone will positively impact your health, many women report significant and often dramatic improvement of symptoms and concerns soon after implant removal. Often women will describe resolution of other symptoms following surgery that they had not associated with BII preoperatively. Women have seen rashes disappear, hair growth resume, allergies subside, chest and joint pain resolve—all well beyond what would be expected by placebo alone. The BII theory of nocebo (when an “inert” substance causes perceived harm) may be inadequate to explain more objective and/or rheumatologic type symptoms reported with BII.

There are also many women who decide to undergo implant removal for a variety of other reasons including discomfort, breasts interfering with daily activity or exercise, breast size increase over time, shape change over time, displeasure with the implants from the initial surgery or currently, desire not to have to deal with removal in the future at advanced age, or simple desire to be smaller, more comfortable, and natural. And breast implants are not lifetime devices. Saline implants can rupture over time deflating, and causing asymmetry, and silicone implants may rupture as well. Many patients have decided to remove implants when they are younger, and in better health.

If you develop unexplained symptoms that you suspect may stem from your breast implants, schedule a consultation with Dr. Rudderman. It is important to understand that symptoms that do not resolve after implant removal should be further evaluated. Treatable illnesses should not be overlooked.

How Common is Breast Implant Illness?

It is not yet clear how many people suffer from BII. The FDA asks people to report BII symptoms so they can keep track of how many people are affected. They currently have received thousands of reports, but the actual number of people affected is likely much larger.

What Causes Breast Implant Illness?

The cause of the symptom spectrum of BII is not clear. Multiple theories are being evaluated including biofilms, heavy metals, allergic reaction, and immune response to a foreign body. What is known is that breast implants are often associated with biofilms—bacteria that become adherent to the implant surface. Biofilms can occur when microorganisms become associated with foreign materials and may be related to bacteria that naturally reside in breast tissue or from introduction during augmentation.

Biofilms are not an active infection and cannot be resolved with antibiotics mostly because the microorganisms use strategies to “evade” the body’s defense and immune system. Biofilms are heavily implicated in patients that develop capsular contraction (tightening of the capsule resulting in hard, often deformed, uncomfortable breast). Biofilms have been demonstrated to activate the immune response in some tissues, potentially leading to tissue damage. DNA and antibody data collected on recent studies have not confirmed an infectious etiology. However, some BII patients were found to have higher levels of some cytokines (proteins that regulate the response to infection).

We also know that implants are constructed of materials that, when used independently, have been associated with potential health concerns. These materials may also be found in many products including food, cosmetics, beauty products, cooking and eating utensils, carpets, rugs, tattoo ink, and in the environment.

It is also suspected that some women’s symptoms may be the result of an allergic reaction or immune response to the small amounts of metals or other materials found in the implant shell. Heavy metal toxicity has been extensively studied, yet recent data from implant removal cases evaluated by the Aesthetic Surgery Education and Research Foundation (ASERF) found metals detected in <10% of the study group including: silver, aluminum, cobalt, molybdemen, selenium, tin, platinum, all with amounts reportedly below considered “safe” levels and not presenting as a clear connection between heavy metal toxicity and BII.

Most of our patients seeking implant removal to alleviate their BII symptoms respond positively in short duration to their explant procedure. Those with clearly defined objective findings, such as chronic skin rashes, for example, have in some cases demonstrated rapid resolution when other treatments have failed. Our positive response rate of reported improvement, reduction, and/or elimination of general BII symptoms remains consistent with recent data from ASERF (which reports a 88% reduction in symptoms at 1 year following implant removal). Their findings indicate that:

>90% of the BII subjects followed at 6 months with symptoms they attribute to their implants do experience symptom improvement after removal of their implants..

There are women who do not have a positive experience with removal for improvement in health and aesthetic appearance and may be regretful of their explantation, making the decision to remove implants worthy of careful consideration. And there are definitely higher surgical risk of capsule removal and breast lift.

Our immune systems react differently to foreign objects in the body, making it nearly impossible at this time to determine a woman’s risk of breast implant illness before augmentation. Any of these factors—or even a combination of these and other factors—may be the cause of BII symptoms in women and may develop with normal aging and hormonal changes.

Implant removal is your choice. Many BII symptoms may be associated with other treatable illnesses. Having a general health screen is good practice and may include blood test (as recommended by your General Practitioner):

• Complete blood count test or CBC
• Metabolic profile tests
• Liver function
• Thyroid function
• Vitamin D levels
• Erythrocyte sedimentation rate (ESR)—a blood test that can show if you have inflammation in your body
• C-reactive protein test (CRP)—CRP levels have been found to be elevated in some with BII and with inflammation
• Autoimmune screens
• Antinuclear antibody (ANA) test
• Rheumatoid factor test
• Ferritin Level
• Serum IgG, IgM
• Autoimmune disease markers
• Antinuclear antibody
• Antineutrophil cytoplasmic antibody
• Anti-double strand DNA
• Anti-Sjogren’s syndrome A
• Anti-Sjogren’s syndrome B
• Rheumatoid factor
• Anti-ribonucleic acid protein
• Anti Sm
• Antiscleroderma antibodies
• Anti-TTG, tissue transglutaminase

And other autoimmune and metabolic screening as determined by your general practitioner.

Symptoms that do not resolve after implant removal should be further evaluated.

Patient Testimonials

“My BII symptoms are relieved! And the results were better than expected. Dr. Rudderman spent plenty of time answering questions and was very knowledgeable about BII. The staff was caring and very responsive.”

“Prior to my breast explant surgery, Dr. Rudderman explained to me what to expect. I was shown pictures of what the appearance of my breasts would most likely look like. After surgery, I had no surprises. Before and after surgery Dr. Rudderman and his staff made themselves accessible to answer any questions that I had. I found Dr. Rudderman and staff to be extremely professional and genuinely concerned about my surgery outcome. The best thing about my treatment results is that I no longer have pain in either of my breast.”

Breast Implant Illness Research and Resources

The lack of objective lab evidence for BII has contributed to some skepticism around this condition; however, the stories of women who claim to be suffering from BII are very compelling. While a causative relationship has not been established, researchers at The University of Texas MD Anderson Cancer Center have found that silicone implants are associated with some rare diseases, autoimmune disorders, and other conditions. The study underscores the need for more research in this area.

Breast Implant Illness Summary

• Breast Implant Illness patients have symptoms. Symptoms are real.
• A significant group of Breast Implant Illness patients experience improvement in symptoms after explantation (implant removal).
• There are many patients without BII who opt for implant removal for a variety of reasons.
• It was your decision to have implants placed. It is also your decision to have implants and capsules removed, with knowledge of the potential risk and benefits of the surgery.

If you are interested in learning more about BII, you may also find these additional articles and resources helpful:

• Danica Patrick’s Breast Implant Illness
• Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1. Glicksman C, McGuire P, Kadin M, Lawrence M, Haws M, Newby J, Ferenz S, Sung J, Wixtrom R.Aesthet Surg J. 2022 Jun 20;42(7):809-819. doi: 10.1093/asj/sjab417.PMID: 34915566 Free PMC article.
• Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women-Biospecimen Analysis Study: Part 2. Wixtrom R, Glicksman C, Kadin M, Lawrence M, Haws M, Ferenz S, Sung J, McGuire P.Aesthet Surg J. 2022 Aug 24;42(9):1067-1076. doi: 10.1093/asj/sjac106.PMID: 35474526 Free PMC article.
• Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 3. McGuire P, Glicksman C, Wixtrom R, Sung CJ, Hamilton R, Lawrence M, Haws M, Ferenz S, Kadin M.Aesthet Surg J. 2023 Feb 3;43(2):230-244. doi: 10.1093/asj/sjac225.PMID: 35980942 Free PMC article.
• Longevity of Post-Explantation Systemic Symptom Improvement and Potential Etiologies: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 4. Glicksman C, McGuire P, Kadin M, Barnes K, Wixtrom R, Lawrence M, Haws M, Ferenz S, Sung CJ, Hamilton RG, Faasse K.Aesthet Surg J. 2023 Sep 14;43(10):1194-1204. doi: 10.1093/asj/sjad098.PMID: 37040435 Free PMC article.
• The Aesthetic Surgery Education and Research Foundation announces the BII Study Task Force
• The Aesthetic Society and The Aesthetic Surgery Education and Research Foundation Unveils Findings from The Biospecimen Study on Breast Implant Illness (BII)
• FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma
• Assessing Long-Term Outcomes in Breast Implant Illness: The Missing Link? A Systematic Review
• Breast Implant Illness: A Way Forward. Mark R Magnusson ¹, Rod D Cooter ¹, Hinne Rakhorst ¹, Patricia A McGuire ¹, William P Adams Jr ¹, Anand K Deva ¹ Plastic and Reconstructive Surgery • March Supplement 2019