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My goal in writing this is not to talk anyone into or out of removing their breast implants if they suspect BII is causing their symptoms, but rather to help educate them on what we know and don’t know about this illness and what we observe with this illness.
I feel that I am in a unique situation to help women with this because of my surgical experience, and scientific experience – having worked at the CDC and able to critically evaluate data. Women need to balance all information that they can get in order to make a decision for surgery since surgery itself carries risks.
What Is Breast Implant Illness (BII)?
Breast Implant Illness (BII) is a term increasingly used by health care providers, media and women who describe a variety of symptoms and attribute these symptoms to their breast implants. This can occur with saline, silicone, textured or smooth implants. Examples include but are not limited to fatigue, chest pain, hair loss, headaches, photosensitivity, brain fog, neurological and hormonal issues, depression, rash, or chronic pain (1).
Until recently, BII has not been studied as a specific entity. BII is not a medical diagnosis, encompasses a long list of potential symptoms, and has no clear definition. There is no test for it either before or after a breast augmentation, and there is no known risk statistic that can be cited or quoted to a patient. Many of the symptoms are similar to other more easily diagnosed syndromes and therefore other illnesses need to be ruled out first. I personally feel it is a real phenomenon in women who experience it.
Do Breast Implants Cause BII?
The majority of women with breast implants (approximately 300,000-400,000 per year in the U.S.), tolerate their implants well without concerns or symptoms. And at present there is overwhelming evidence to support the safety of breast implants (2). To date, there is no proven scientific link between saline or silicone implants and any defined autoimmune disease. There may be a subset of women who may be particularly sensitive to any changes that may occur, or inflammation in their body that may cause them to experience implants differently from other women
There are currently several ongoing studies looking at the effect of implant removal on symptoms. Many patients appear to have some improvement lasting 12 months, but response is variable. Some patients report no improvement.
In 1999, the Institute of Medicine Committee on the Safety of Silicone, conducted an extensive review and concluded there was no clear link between silicone implants and any systemic illness. Many studies have searched for a connection and in aggregate, these studies show no definite link between breast implants and any specific disease, and patients who report that they have BII have not shown consistent laboratory abnormalities to define a distinct syndrome.
For example, I have tested several of my implant removal patients prior to surgery for markers in their bloodwork indicating inflammation, and all were normal. This rules out significant inflammation as a common mechanism, although I still feel it could be contributing. This is just one example of the complexity of trying to tie these symptoms together.
What Is the Risk of Developing BII?
There is no known risk statistic that can be cited since there is no known epidemiological evidence to support a link between breast implants and any specific disease. Rare and unusual disease processes can take years to come to a scientific conclusion, and currently there is no specific diagnostic test.
The lack of a proven scientific link between implants and BII does not mean that the symptoms experienced by these patients are not real or that a link may not be discovered in the future. If a patients symptoms resolve after implant removal, the presumptive diagnosis is BII.
Does Implant Removal Cure Symptoms of BII?
One recent paper (3) looked at 750 patients who had their implants removed by one surgeon and reported a significantly statistical improvement in symptoms, however, this study had significant limitations and did not definitively show that implants caused BII or was cured by removal.
For women who elect to have their implants removed: some get better or partially better, others get better for a period of time, and still others experience no change in symptoms, meaning symptoms could be caused by other factors. There are no studies that indicate which symptoms may or may not improve after implant removal with or without capsulectomy, and there are no studies or scientific evidence that a diagnosed autoimmune disease will be cured with implant removal. Symptom relief seems to be equally likely after en bloc vs. a precise capsulectomy. I have even had several patients (and know of others) who had their implants put back in after experiencing no change in their symptoms after removal.
En Bloc vs Total Capsulectomy
All breast implants will cause your body to form a scar tissue capsule around the implant. This is a normal process. A capsulectomy is the removal of that scar tissue capsule.
En bloc capsulectomy requires complete dissection and removal of all the tissues surrounding the breast implant (the scar capsule plus a rim of native breast tissue) and is usually reserved for cases of a known malignancy where the increased surgical risks are balanced against a potential cancer cure.
Not all surgeons routinely remove the capsule with implant removal, but it is something I do often in these situations. More extensive capsulectomy, and/or en bloc capsulectomy requires accepting potentially a larger incision and increases the risk of damage to adjacent structures and/or complications. The difference in approach to the capsule is something that needs to be discussed at your consultation.
There is not enough data to guarantee any improvement in symptoms with an en bloc resection vs capsulectomy. For example, in one study, 69 patients underwent en bloc capsulectomy, and 31 patients underwent total capsulectomy — there was no difference in the percentage of patients who reported resolution of symptoms (1).
Recommendations
Implant removal alone, implant removal and breast lift, fat grafting, implant exchange, capsulectomy, and en bloc capsulectomy can and have been employed in my practice during revision breast surgery, depending on the situation and patient concerns. I have been performing all kinds of revision surgery for various reasons throughout my career, so this management is not anything new to my practice.
In my practice, women with any concerns related to their breast implants need to be heard and believed, and evaluated and a plan forward formulated based on their symptoms, and their preferences once fully informed. BII is a complex issue, but if you feel you are experiencing it we will have a frank discussion about what is known and unknown, and your options.
References
1)The Aesthetic Society (ASAPS) Advisory Update: August 2020 FAQ BII
2)Rohrich RJ, Kaplan J, Dayan E: Silicone Implant Illness: Science versus Myth? PRS 144(1):98-109, July 2019.
3)Feng L-J, et al: Understanding Breast Implant Illness, Before and After Explantation A Patient Reported Outcomes Study. Ann. Plastic Surg. 2020;85:S82-S86.
