BII (Breast Implant Associated Illness) – FAQs

“Breast implant illness” (BII) is a term used by women who have breast implants and describe a variety of symptoms including (but not limited to) fatigue, chest pain, hair loss, headaches, chills, photosensitivity, chronic pain, rash, body odor, anxiety, brain fog, sleep disturbance, depression, neurologic issues, and hormonal issues that they feel are directly connected to their saline or silicone, textured or smooth breast implants. The recent increase in patients reporting breast implant illness symptoms appears to be highly related to social media. There is one Facebook group alone with more than 70,000 members, all of whom report breast implant illness symptoms. This is not to say that social media is the cause of breast implant illness; however, it may account for the rapid increases in patient reporting. BII is not an official medical diagnosis.

Silicone is an element that exists in nature as crystalline silica. It has been shown to activate the immune system in conditions such as systemic sclerosis, which has been seen in stonemasons. The silicone used in breast implants is different, and to date has not been proven to cause any disease. This silicone does not exist is nature; it is created by hydroxylating silica to form polydimethylsiloxane. Medical-grade silicone has had antioxidants, dyes, and plasticizers removed during processing.

There is no diagnostic testing specifically for breast implant illness. This is one of the current areas of focus for The Aesthetic Surgery Education and Research Foundation, which is the research arm of The American Society for Aesthetic Plastic Surgery. There are tests for autoimmune diseases that can be performed to evaluate the potential causes of a patient’s symptoms. There are patients who have symptoms that they attribute to breast implant illness with positive immune testing, and others with all laboratory tests which show no abnormalities.

In 1999, The Institute of Medicine Committee on the Safety of Silicone conducted an extensive review of the available literature and concluded there was no demonstrated clear link between silicone implants and any systemic illness. There have been studies of many different sizes and designs to look at the safety of breast implants themselves. These have looked at specific autoimmune disorders and diseases. In aggregate, these studies show little to no links between breast implants and any disease. Studies of patients who have symptoms that they have related to their breast implants have not shown consistent laboratory abnormalities to define a distinct syndrome. To date, there has been very little in the way of research into this entity that has been labelled “breast implant illness” by women with breast implants.

Various studies show different degrees of improvement in patient symptoms after removal of their breast implants — some of which are temporary, and some showing permanent resolution of symptoms. There are no studies that specifically show which symptoms may or may not improve with implant removal with or without capsulectomy. There is no current definitive epidemiological evidence to support a direct link between breast implants and any specific disease process. However, this does not mean further research is not indicated. In rare and unusual disease processes, it can take years to come to a scientific conclusion. There are many factors that can affect the interaction between a patient and her breast implants. Further study is required to determine the best way to potentially screen patients prior to breast implant surgery and to determine which of the multitude of reported symptoms might improve with implant and capsule removal. A lack of a direct, proven scientific link does not mean that the symptoms experienced by these patients are not real. Some patients have legitimate concerns about a potential link between breast implants and symptoms, so it deserves our attention and further scientific research to better determine what symptoms may improve with explanation of implants.

Because there are many women that self-identify as having breast implant illness, we are listening. ASAPS and ASERF are developing a new scientific study to examine this entity. They are also providing plastic surgeon members with a questionnaire to use to collect a record of complaints from patients with implants, as well as one to utilize for post-explantation. We cannot yet define BII, and therefore we cannot say with any certainty that it exists because we do not have any tests to run to prove or disprove its existence. However, we can listen to and partner with our patients to determine what the best course of action is to address their complaints — be it explantation or otherwise.

We will not ignore our patient’s concerns. Their symptoms are real, and whether or not they can or cannot be attributed to implants isn’t relevant because there is simply no existing way to prove nor disprove causation or association. Options include:

• Further medical workup with or without the consultation of a rheumatologist
• Observation without medical workup
• Implant removal without capsulectomy
• Exchange with or without capsulectomy
• Removal with total capsulectomy
• Removal with en bloc capsulectomy

Patients who present with concerns of breast implant illness have real symptoms that often cannot be categorized into any specific known disease entity. This does not mean their symptoms are not real. These patients deserve a full evaluation. The various options need to be discussed, and hopefully with further research, we may be able to determine which patients may see symptom improvement or resolution with removal of their implants and which may not see any change.

As there is no definitive link between the often subjective and divergent list of symptoms — and no means for testing — there is no “known” risk. Many of the symptoms described by breast implant patients are experienced by the general public on a regular basis, with or without implants. This isn’t stated to write off a potential connection, but no connection has been established to date.

Patients should, however, be informed of the risks that can be associated with breast implants, including (but not limited to) BIA-ALCL, a rare spectrum of disorders that can range from a benign accumulation of fluids around the breast (seroma) to an extremely rare lymphoma. They should know that BIA-ALCL is not a cancer of the breast tissue itself and that when caught early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.

There are many medical inaccuracies perpetuated by the Internet. Some patients believe that a total capsulectomy is necessary to remove all causative agents, and they prefer it be en bloc — oftentimes without having a full understanding of what size incision is necessary for en bloc procedure. We like to discuss the reasons why we would perform a total capsulectomy with any patient. Not all plastic surgeons routinely perform a capsulectomy with explant, but some do. It is important to explain that it’s not always possible to remove all of the capsule. Sometimes a portion of the capsule must be left behind or is disintegrated with the use of electrocautery to prevent significant damage to muscle, rib, or lung. A larger incision is needed for an en bloc capsulectomy. If axillary approach or periareolar approach was used for breast implant placement, it must be noted that patients cannot have the procedure done through those incisions. There are increased surgical risks associated with en bloc capsulectomy which requires a complete dissection of all the tissues surrounding the breast implant. We do not have enough collective data to guarantee any improvement in symptoms labelled breast implant illness.