Breast Implant Illness

Actual Patient

Patients who are either considering breast enhancement or currently have implants should be aware of BII and BIA-ALCL, both of which are receiving media attention. Knowledge of the current scientific understanding of implants and associated risks should help alleviate some stress that can be generated by social media and news coverage:

Breast Implant Illness (BII) Link between medical grade silicone implants and disease? Are there any tests? Any data showing causation between implants and symptoms/disease? Does implant removal improve patient’s symptoms? Better understanding this group of systemic symptoms Patient complaints of BII symptoms? Risk of developing Breast Implant Illness (BII)? Explanation of “en bloc” or “total” capsulectomy?

What is Breast Implant Illness (BII)

There are women with breast implants who self-identify and present with various systemic symptoms and believe that these are related to their breast implants. They refer to these symptoms as "Breast Implant Illness" (BII).

BII is a term used by women who have breast implants and who self-identify 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 related to social media. There is one Facebook group alone with more than 70,000 members, all of whom report BII symptoms. This is not to say that social media is the cause of BII however, it may account for the rapid increases in patient reporting. BII is not an official medical diagnosis.

Is there a link between medical grade silicone implants and any disease?

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

Actual Patient

Are there any tests that would indicate a connection between breast implants and symptoms that are being labeled Breast Implant Illness (BII)?

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

Is there any scientific data showing causation between implants and these symptoms or any disease entity?

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 labeled BII by women with breast implants.

Does implant removal improve a patient’s symptoms or cure a patient who has a medically diagnosed disease entity like an autoimmune disease?

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.

What is being done to better understand this group of systemic symptoms being called Breast Implant Illness?

Because there are many women that self-identify as having BII, the Aesthetic Society and ASERF are developing a new scientific study to examine this entity. We are also providing our 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 cannot say with any certainty that it exists, because we do not have any tests we can run to prove or disprove its existence. However, we can listen to and partner with our patients to determine what is the best course of action to address their complaints, be it explantation or otherwise.

What can a physician do when a patient complains of BII symptoms?

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 and they 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. Treatment options include: further medical work up with or without the consultation of a rheumatologist, observation without medical work up, implant removal without capsulectomy, exchange with or without capsulectomy, removal with total capsulectomy, or removal with en bloc capsulectomy.

What is the risk of developing Breast Implant Illness (BII)?

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. That isn’t to write-off a potential connection, but no connection has been established to date. Breast implants do have known risks, 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. BIA-ALCL is not a cancer of the breast tissue itself and when caught early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.

Actual Patient

What should be done if the patient demands an “en bloc” or “total” capsulectomy with their explantation?

There are many medical inaccuracies perpetuated by the internet. BII patients tend to believe that a total capsulectomy is necessary to remove all causative agents and they prefer it en bloc, oftentimes without having a full understanding of what size incision is necessary for en bloc. A total capsulectomy is normally performed on patients who have a SIGNIFICANT scar capsule around the implant, and generally requires an incision as long as the width of the implant (3 to 5 times larger than the incision used to put in the implant. Even when a surgeon plans to perform a total capsulectomy, it is 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. There are increased surgical risks associated with en bloc capsulectomy which requires a complete dissection of all the tissues surrounding the breast implant and since we do not have enough collective data to guarantee any improvement in their symptoms they have labeled Breast Implant Illness.

Breast Implant Illness

What is Breast Implant Illness (BII)

Is there a link between medical grade silicone implants and any disease?

Are there any tests that would indicate a connection between breast implants and symptoms that are being labeled Breast Implant Illness (BII)?

Is there any scientific data showing causation between implants and these symptoms or any disease entity?

Does implant removal improve a patient’s symptoms or cure a patient who has a medically diagnosed disease entity like an autoimmune disease?

What is being done to better understand this group of systemic symptoms being called Breast Implant Illness?

What can a physician do when a patient complains of BII symptoms?

What is the risk of developing Breast Implant Illness (BII)?

What should be done if the patient demands an “en bloc” or “total” capsulectomy with their explantation?

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