Breast Implant Illness

Breast implant illness (BII) encompasses a range of symptoms that a relatively small group of women have reported several years after getting breast implants. BII has been the subject of media attention, along with Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Dr. Mosher wants to ensure women considering breast augmentation or who already have breast implants are fully informed about BII and BIA-ALCL. Understanding the most current information about the risks associated with breast implants is an important part of feeling confident and well informed.

Based on clinical information from the American and Canadian Societies for Aesthetic Plastic Surgery, we are providing this information about BII and another about BIA-ALCL to provide people with answers to their questions.

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). Breast Implant Illness (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 (BII) symptoms appears to be facilitated by access to information online and communicated throughtsocial media. Large numbers of women with implants feel that there must be a direct link between their implants and their compromised health. Scientific research into this observation is extensive and ongoing. BII is not currently recognized as an official medical diagnosis because the scientific studies have not confirmed this disease.

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. 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.

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

There is no diagnostic testing specifically for Breast Implant Illness (BII). 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.

What is ASIA and is this related to Silicone Breast Implants?

In 2011, a syndrome called “autoimmune syndrome induced by adjuvants” was introduced whereby patients who had been exposed to some external stiumulus developed a constellation of systemic symptoms. There are Major Criteria and Minor Criteria that must be present to fulfil the criteria for ASIA. Some scientists believe the features of ASIA are similar to those exhibited by a small percentage of patients with silicone breast implants who believe that they have BII. In one Dutch study (mMaijers 2013) of women with silicone implants and who met these ASIA diagnostic criteria, approximately 60% experienced symptom improvement after having their breast implants removed. Observational studies like these provide some support for the consideration of implant removal in some women. Larger and well-designed studies need to be completed before definitive answers about BII will be available. The Plastic Surgeons at YES support breast implant removal for women wanting to pursue this option.

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 design 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 (BII) by women with breast implants.

Does implant removal improve 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 which 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.

What does Dr. Mosher recommend for patients who complain of Breast Implant Illness symptoms?

At YES, we understand that there are no current definitive tests that can prove or disprove the existence of this condition. However, we know that these symptoms are real to our patients. It is imperative that patients consider the more common and well recognized diseases that can cause these symptoms. Prior to considering surgery, we recommend a thorough medical work-up by the patient’s primary care physician and often by a Rheumatologist or other relevant Specialist. We then consider: further medical work up, observation without medical work up, medical imaging of the breast implants, implant removal without capsulectomy, exchange with or without capsulectomy, removal with total capsulectomy, or removal with attempted 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.

How does Yes Cosmetic Surgery Centre respond to patients requesting en bloc removal of implants and capsules?

Online women’s health advocacy groups often insist that patients ask for en bloc removal of their implants and capsules. The basic premise is that by removing the implants and surrounding capsule together or “en bloc” that this technique produces better outcomes for patients. Although well intentioned, this recommendation is not supported by medical evidence and can cause unnecessary harm to women wanting their implants removed.

Total capsulectomy is recommended when there is a ruptured silicone gel implant or when implants are removed and replaced in the presence of a thick or pathologic capsule. The techniques to remove the implant and capsule strike a balance between safety and cosmesis. All experienced Plastic Surgeons have the skills to perform this procedure.

En bloc is a surgical oncologic technique aimed at reducing the risk of local reoccurrence of malignancy for solid malignant tumours. For BIA-ALCL, the implant, the implant capsule and a layer of surrounding normal tissue is removed together. The technique requires long incisions and is associated with many more post-operative complications that implant removal with total capsulectomy. Common complications include hematoma, seroma, pain and cosmetic deformity. Rarely, there can occur injuries to the adjacent nerves, large blood vessels, heart and lungs. For BII, oncologic surgical techniques provide no proven benefit and have proven higher complication rates. For our patients, Dr. Mosher endeavours to remove all of the breast implant and all of the surrounding capsule without taking excessive risks of severe complications. En bloc removal can never be guaranteed and may actually unnecessarily dangerous to attempt.

Are the implants and tissue removed tested for disease?

When breast implants and their surrounding capsules are removed for benign conditions such as symptoms of BII, breast implant rupture or capsular contracture, the capsular tissue removed is sent for pathologic examination. Although rarely encountered, fluids or masses observed during surgery are also sent for pathologic examination.

Do patients get to keep their removed implants?

Many patients request their removed implants for personal curiosity or perhaps for evidence and third party assessment. In British Columbia, any tissues or medical devices removed from a person are classified as “biohazardous waste” and must be handled and disposed of according to Provincial legislation. Implants removed are photographed and if patients are eligible for a manufacturer limited warranty consideration, the devices are returned to the manufacturer. After surgery patients can observe and touch their implants after they have been placed in an appropriate protective container. Patients are not permitted to take their removed implants home.

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