Breast Implant Removal (Explant)
I long counseled patients considering breast implants that extensive research performed over many years appeared to provide a high confidence level that implants are systemically safe. I also acknowledged, however, that I was open-minded to the possibility that over time, our knowledge regarding potential issues associated with breast implants may change. Experience leads to evolution in our understanding of many things. We are now in an era that requires a shift in perspective. Although the FDA continues to classify breast implants as safe, they have applied a black box warning, and now mandate a detailed decision-making checklist to ensure that prospective patients are aware of recognized and potential risks. Although the list of potential risks includes many issues of variable frequency and severity, two are of particular interest currently: Breast Implant Associated Large Cell Lymphoma and Systemic Systems and Breast Implants, or Breast Implant Illness.
Breast-Implant-Associated ALCL and Breast Implant Illness
Today, we are dealing with two relatively new issues relative to breast implants: Breast Implant-Associated ALCL (BIA-ALCL) and “Breast Implant Illness” (BII). BIA-ALCL is NOT breast cancer; rather, it is a rare form of lymphoma that is predominately associated with “textured surface” breast implants. This condition is an accepted diagnosis that is definitively established with pathologic study of implant pocket fluid or capsular tissue. Research has not yet established an underlying mechanism for this cancer, although genetic factors and chronic inflammation are suspected. BIA-ALCL commonly manifests as breast swelling from a fluid collection surrounding the implants. Capsular tightness and nodules are another potential sign. Most patients are successfully treated with surgery. As with many cancers, however, some patients do require advanced forms of chemotherapy. A small but concerning number of deaths have occurred. The majority of cases have been associated with macrotextured breast implants,specifically a type named Biocell. Because of that observation, Biocell breast implants were recalled in July 2019. The FDA does not recommend routine removal of Biocell implants in the absence of signs or symptoms. Patient education and surveillance is advised due to the risks of surgery. After a discussion of relative risks, patients can opt for elective implant removal if they prefer. Allergan provides replacement smooth implants for patients electing that course. Research is ongoing, but the hope is that the incidence will decrease significantly by removing the most commonly associated implant type from active use. Some patients have concerns that BII leads to BIA-ALCL. Currently, there is no evidence to suggest this association in the majority of BIA-ALCL patients.
BII, on the other hand, is not an accepted diagnosis. It is controversial, as it has no specific or uniform clinical, laboratory or pathology correlations. There are no diagnostic criteria or tests for BII. This does not mean that it does not exist; it simply means that we do not have enough scientifically verified information to establish its existence. Therefore, most experts currently describe “Breast Implant Illness” as a symptom complex rather than a disease. Some prefer the phrase "Systemic Symptoms and Breast Implants" or SSBI, to both recognize that some women with breast implants do have unexplained symptoms, while also emphasizing that we do not yet have clear evidence that breast implants are the cause. In either case, the labels describe a situation in which patients are experiencing a broad range of non-specific symptoms that are often associated with chronic inflammation. The symptoms often vary from patient to patient in terms of presence and severity. Patients do not seem to fit any particular pattern in terms of physical traits or lifestyle. BII can affect patients with any type of implant, saline or gel, smooth or textured.
Some patients experience “mechanical” issues with their implant such as tension, pressure, excess weight, stiffness and immobility. They often have chronic pain in the breast or chest area. These symptoms are often associated with oversized implants and implants positioned below the pectoral muscle, and can occur in the absence of capsular contracture (excessive scar tissue). Although some surgeons have observed a high incidence of capsular contracture in their BII patients, I have not observed that possible correlation. The majority of my patients with systemic symptoms have no contracture. However, burning or stinging in the lateral breast area is commonly reported even if the implants are otherwise soft and comfortable. The cause is unclear, but may represent inflammation in the the tissues surrounding the implant. Gel rupture is another common cause of that burning symptom. These types of symptoms in the local breast and chest wall reliably improve with removal of the implants.
Most patients, however, also have some type of systemic symptomatology. These issues can occur in conjunction with the physical complaints, or independent of those problems. The most commonly described symptoms are fatigue, difficulty concentrating, joint and muscle pain, gastrointestinal issues similar to irritable bowel, changes in the skin and hair, and restlessness or anxiety. Many other symptoms are also reported. I have tried to categorize the symptoms, and I believe they have characteristics of chronic inflammation due to low-grade allergy and autoimmune activation, neurotoxicity, hormone disruption and possibly even chronic low-grade infection. A ignificant majority of patients with systemic symptoms also improve with implant removal. The underlying mechanism for these symptoms, and therefore the apparent improvement following explant, is unknown. However, I have had the experience of meeting many of these women each week, and it is clear to me that their symptoms are real. I appreciate their frustrations with physicians who often refuse to acknowledge their implant concerns, or who try to help but are unable to provide diagnosis or effective treatment. What is not clear is why these patients are suffering. I am concerned that these problems may be due to something that we have failed to recognize and investigate with adequate broad-mindedness and diligence. Because of my relatively early acceptance of BII in central Indiana, and my large explant practice, I was invited to collaborate with a research team at Indiana University School of Medicine. Dr. Mithun Sinha is a talented and passionate scientist who is committed to unraveling the complex immune responses and interactions that likely underpin the symptoms of BII. The team has published a literature review that summarizes manuscripts both in favor of the possiblity of BII, and against. A sufficient number of supportive manuscripts exist to establish BII as plausible. More recently, we were very excited to publish a manuscript that identifies a possible cellular and molecular basis for BII. This manuscript was subject to lengthy critical peer review prior to publication, and has received unsolicited favorable commentary from an acclaimed immunology scientist. Details are on my News page. We believe, as do others, that this research is ground-breaking evidence of BII as a disease, not a fictitious malady.
Breast Explant Surgery
Initially, I had some discomfort with the concept of removing breast implants for a controversial condition. I can’t test for BII, and I couldn’t provide reasonable assurance of symptom improvement. I offered alternate explanations such as diet, stress and Lyme disease. Most patients, however, had already explored those possibilities without success. Ultimately, I believe that patients have the right of self-determination. Just as they decided to have the implants placed, they have the right to request removal.
To date, I have removed breast implants from approximately 500 patients with BII concerns. Over the course of my career, I have explanted thousands of women with recurring capsular contractures, mechanical pain, and unwanted size. Reassuringly, my patients have consistently indicated high levels of appreciation and satisfaction with their outcomes. Gratifyingly, nearly all of the BII patients have indicated symptom resolution or significant improvement within weeks to months of explant. Some were on disability and were able to return to work. Other plastic surgeons throughout the country are reporting similar experiences. As the experience grows, the acceptance of BII as a real medical condition grows.
On the other hand, many other plastic surgeons, general practitioners and specialists remain skeptical and say these women are experiencing severe anxiety and/or are fabricating medical symptoms that have no cause. Others accept the symptoms as real but believe they are unrelated to the implants, and any improvement is a psychosomatic or self-fulfilling outcome. In my experience, however, most of my patients were completely unaware that their implants might be making them sick until they exhausted attempts at medical diagnosis and failed multiple management approaches including conventional medication, integrative medicine treatments and lifestyle changes such as dietary restrictions. They present as rational, reasonable people who are not angry, accusatory or panicked. They are aware that the stories online are anecdotal. Many describe unease with the overly dramatic online posts they read. They realize mainstream scientific studies contradict their claims. Yet, they recognize similarities to their own experience, and they feel that implant removal is an option they must explore. Individually, each patient realizes she might not improve with the explant surgery and that esthetically, she is going to look very different. They accept the cosmetic consequences in the hope of regaining health.
Where Do We Go From Here?
Am I still using breast implants? This is a question that some advocacy groups suggest is a screen for identifying legitimate explant sugeons. I do continue to use breast implants. I still perform augmentation procedures and I still perform breast reconstruction with implants. I remove and replace ruptured implants in women who have no sytemic symptoms and wish to remain augmented. Breast implants remain useful devices for many situations. I doeducate and inform my patients of the known possibility of BI-ALCL and the potential for symptom complexes referred to as BII. Unfortunately, we do nothave consistent statistics regarding the true incidence of BI-ALCL, and we have no definition of BII to even begin to establish a possible incidence for that condition. Most likely, however, BII affects only a small percentage of implant patients, or we would have become aware of the possibility long before now. Social media, while criticized for being a potential driver of this “factitious” phenomenon, may actually be helping to connect affected patients and bring our attention to a real problem. My own experience working with these women suggests to me that significantly more research is needed. There is so much we don’t know and much to learn about this complex of symptoms. I am grateful to have the opportunity to contribute to this emerging area of inquiry.
Because I have become a “go-to” plastic surgeon for explant surgery due to this condition, I have many thoughts and questions. First, I would like to determine the most common and suggestive symptoms. With a consensus definition of the symptoms, we can try to establish the incidence of this complex in the implanted population. Additionally, for patient education and consent, it would be helpful to know if there are certain patient specific factors, such as certain genetic types, that seem to be more at risk. For diagnosis, are there any laboratory studies that are commonly abnormal, such as elevated inflammatory markers, or is there a way to test for possible sensitivities to specific chemical components of the implant? Is there a more effective way to evaluate the implant pocket or implant surface for microbial populations such as biofilm? Can we be more specific in our histopathologic analysis of the implant capsules?
The Food and Drug Administration (FDA) is actively reviewing these questions and will make recommendations as Committee hearings continue. For now, the agency continues to classify breast implants as safe and effective. Patient advocates have voiced sufficient concern, however, to cause the FDA to place a black box warning on breast implants.
I will keep patients updated on my website and my Facebook page as developments occur in the areas of regulation and research.