What Causes Breast Implant Disease?

Breast implant illness (BII) is a term used by some women and physicians to refer to a variety of symptoms that can develop after reconstruction or cosmetic augmentation with breast implants.

Occasionally, it is also known as the autoimmune/inflammatory syndrome induced by adjuvants (ASIA). BII can occur with silicone gel-filled, saline-filled, smooth surface, textured surface, round, or teardrop-shaped breast implants.

BII affects each individual in a distinct manner.

Symptoms may consist of:

joint and muscle pain

Chronic exhaustion

problems with memory and concentration

breathing difficulties

sleep disturbance

rashes and skin conditions

mouth and eye dryness

anxiety

depression

headaches

hair loss

gastrointestinal problems

After implant surgery, the symptoms can manifest at any time; some people develop symptoms immediately, while others develop them years later.

Numerous BII symptoms are linked to autoimmune and connective tissue disorders, including lupus, rheumatoid arthritis, and scleroderma. Many people with BII are not also diagnosed with a specific autoimmune or connective tissue disorder.

In many, but not all cases, breast implant removal surgery improves or completely eliminates BII symptoms.

BII is not presently recognized as an official medical diagnosis, and there is no corresponding diagnostic code. As a unique condition, it is poorly understood and has not been studied extensively.

According to Diana Zuckerman, Ph.D., president of the National Center for Health Research and a researcher who studies breast implant safety issues, BII is a collection of symptoms that do not fit into any other classic disease diagnosis. We believe it will eventually be acknowledged as a medical condition, but this will take time.

In recent years, the U.S. Food and Drug Administration (FDA), the major plastic surgery societies, and other health authorities have paid increased attention to BII.

In May 2019, the FDA released a statement indicating that agency officials are taking steps to better characterize [BII] and its risk factors, and are considering ways to ensure women have all the information they need to make informed decisions about whether to obtain breast implants or to remove existing breast implants in order to reverse systemic symptoms.

In October of 2019, the agency released a draft of breast implant labeling recommendations to manufacturers. The agency advised manufacturers to include information about the risk of systemic symptoms in a boxed warning and a patient decision checklist in patient information booklets.

The American Society of Plastic Surgeons and the Aesthetic Surgery Education and Research Foundation are also developing and funding new BII research.

Cases of breast implant-related illness

To date, there have been no studies examining the prevalence of BII among women with breast implants. In recent years, more women have reported BII symptoms to doctors and the FDA, which may be a result of social media groups and media coverage helping to raise awareness of the condition. Thousands of women have joined online breast implant illness communities. For instance, the Breast Implant Illness and Healing by Nicole Facebook group has over 100,000 members at present.

Diagnostics for breast implant disease

There are currently no commonly utilized diagnostic tests or diagnostic criteria for BII.

It is common, according to plastic surgeons who have treated many patients with BII, for those seeking treatment to have multiple symptoms that impair their ability to function. Before realizing that their symptoms may be linked to their implants, many patients have visited a number of other doctors.

Robert Whitfield, MD, FACS, a plastic surgeon in Austin, TX, who treats patients with BII and is the 2019 president of the Aesthetic Surgery Education and Research Foundation, says his clients with BII typically find him after exhausting all other medical avenues and undergoing exhaustive medical testing.

Typically, a plastic surgeon should rule out other potential causes of symptoms (that are unrelated to the breast implants). This may involve examining the patient's test results (such as tests for diagnosing arthritis or Lyme disease) and determining if any symptoms improved when the patient was treated for other conditions. In certain instances, a patient may be diagnosed with both BII and an autoimmune disease or other condition.

Remedy for breast implant disease

Breast implant illness is poorly understood, and different plastic surgeons treat it in different ways.

Plastic surgeons with extensive experience treating BII told us that removing the implants and the surrounding scar tissue capsules, as opposed to replacing the implants, is the treatment most likely to improve symptoms over time.

They stated that it is essential to request that your surgeon remove the scar tissue capsules, as this is an integral part of the treatment.

Some plastic surgeons recommend an en bloc capsulectomy, which removes the implant and capsule in one piece. Theoretically, this method could prevent silicone, biofilm (colonies of bacteria that adhere to the implant) and other substances from escaping the capsule and entering the body.

Complete removal of the scar tissue capsules may also reduce the likelihood of fluid accumulation after surgery (this is known as a seroma). Others may suggest a total (or complete) capsulectomy, which entails the removal of both the implant and the capsule, but not in one piece.

Some women with BII symptoms choose to replace their implants with new ones of a different type, such as switching from textured silicone gel to smooth saline-filled implants. This approach may alleviate BII symptoms, but it may increase the likelihood that they will return over time.

I tell patients with BII symptoms that I do not recommend breast augmentation because they are likely predisposed to implant-related reactions.

In addition, both the saline and silicone varieties are constructed from similar materials. Matthew G. Stanwix, MD, FACS, a plastic surgeon in private practice in Richmond, VA who treats patients with BII, states that both have silicone shells. However, the decision ultimately rests with the patient.

If you are considering surgery to treat BII symptoms, you should discuss the risks and benefits of the various surgical treatment options with your plastic surgeon.

Additionally, it is impossible to predict whether the removal of your implants will alleviate or eliminate your BII symptoms.

Outcomes after breast implant removal to treat illness

There are few studies on the outcomes of implant removal surgery for BII. According to the American Society for Aesthetic Plastic Surgery, a small study of 100 patients with self-reported BII in one surgeon's practice revealed that 89% of patients who underwent implant removal and capsulectomy experienced improvement in some symptoms within three months.

1 Among the symptoms that improved were fatigue, cognitive difficulties, chest wall and breast burning pain, dry eyes, anxiety, and joint pain. In 2013, Dutch researchers published a second study that examined 80 women with silicone gel-filled implants and autoimmune symptoms. 2 Sixty-nine percent of the women whose implants were removed exhibited symptomatic improvement.

According to the plastic surgeons with whom we spoke, many but not all of their patients have experienced a reduction in BII symptoms following the removal of their implants.

After implant removal surgery for BII, a healthy diet, regular exercise, and reduced stress may be particularly beneficial, according to some physicians. These steps may promote healing and reduce the inflammation associated with BII in the body.

Who may be susceptible to breast implant illness?

Some doctors who have treated a large number of patients with BII report that it is more prevalent in those with a personal or familial history of autoimmune disorders, allergies, and conditions such as irritable bowel syndrome, migraines, chronic fatigue, or fibromyalgia.

However, some women with BII have none of these risk factors. There is no evidence that a history of breast or other cancer increases the risk of developing BII.

What causes implant-related illness?

Researchers are unaware of the causes of BII in some women with breast implants. According to experts, the leading theory is that some people are predisposed to having an immune reaction to the materials used to make breast implants, causing inflammation that manifests as joint and muscle pain, rashes, and gastrointestinal issues.

Studies have shown that substances from breast implants (such as very small amounts of silicone and platinum) can leak into the surrounding tissue through an intact shell.

Substances from an implant may also spread within the capsule of scar tissue surrounding the implant or to other areas of the body, typically due to a ruptured implant.

A breast implant is more likely to rupture the longer it is in place. Not all individuals with BII are found to have a ruptured implant.

All women with breast implants are exposed to silicone to some degree due to the silicone shell of all implants.

It is possible that the immune system is reacting to the silicone polymers that have been released from the implant into the body, says Lu Jean Feng, MD, a plastic surgeon who has been treating patients with BII since the early 1990s. Some individuals may have a genetic disposition to be more reactive.

Since the early 1990s, Jan Willem Cohen Tervaert, MD, PhD, director of the division of rheumatology at the University of Alberta in Canada and professor of medicine and immunology at Maastricht University in the Netherlands, has investigated potential links between breast implants and autoimmune diseases.

At the March 2019 public meeting of the FDA's General and Plastic Surgery Devices Advisory Panel on breast implants, he presented an overview of scientific evidence that silicone in breast implants can activate the immune system, resulting in inflammation and autoimmune disorders.

Currently, it is not widely accepted in medicine that silicone in medical devices can affect the immune system. In March of 2019, the FDA announced that it is undertaking new efforts to evaluate the safety of medical device materials, including silicone.

Emerging breast implant illness research

Existing scientific literature does not demonstrate a definitive connection between breast implants and autoimmune or connective tissue diseases, nor does it demonstrate that breast implants cause these conditions.

A couple of recent studies suggest that breast implants filled with silicone gel are associated with a slightly increased risk of developing an autoimmune or connective tissue disease.

One of the reasons these studies are noteworthy is that each included a greater number of women followed over a longer period of time than the vast majority of previous studies on the safety outcomes of breast implants in women.

In a study published online in September 2018 3 in the journal Annals of Surgery, a team of researchers from the University of Texas MD Anderson Cancer Center (including Dr. Clemens) examined the medical records of 99,993 women who had implants and were enrolled in FDA-mandated long-term safety studies.

The researchers discovered that women with silicone gel-filled implants were eight times more likely to be diagnosed with Sjogren syndrome, an autoimmune disorder characterized by dry eyes and a dry mouth, than women in the general population.

7 times more likely to be diagnosed with scleroderma, a group of autoimmune diseases that harden and tighten the skin and connective tissues. rheumatoid arthritis diagnosis is nearly six times more likely.

Some of the diseases were self-reported by patients and were not necessarily diagnosed by a medical professional.

Multiple protocols were used to collect outcomes, and a significant number of patients dropped out before the studies concluded.

In a study published online in October 2018 4 in the International Journal of Epidemiology, a team of researchers (including Dr. Cohen Tervaert) reviewed the electronic health records of 123,255 Israeli women (24, 651 had silicone gel filled breast implants and the rest did not have breast implants).

The records contained data for up to twenty years. The researchers discovered that women with silicone gel-filled breast implants were significantly more likely to be diagnosed with autoimmune or rheumatic disorders, such as Sjogren syndrome, systemic sclerosis, and sarcoidosis, than women of the same age and socioeconomic status who did not have breast implants.

What all of this might imply for you

Discuss with your plastic surgeon and other doctors whether you have any of the potential risk factors for BII, such as a personal or familial history of autoimmune diseases or allergies, if you are considering getting breast implants for the first time or replacing existing implants.

Considering alternatives to implants, such as autologous reconstruction, may make sense if you have any of the risk factors.

If you suspect that you have BII, you should seek out a board-certified plastic surgeon who has experience treating patients with the condition, or at least one who takes your concerns seriously and is not dismissive of the symptoms you are experiencing.

Do not assume that the surgeon who placed your implants is also the surgeon you should select to remove them.

Most private health insurance plans cover breast implant removal surgery for women who have undergone a mastectomy and breast reconstruction.

Since there is no diagnostic code for BII, plastic surgeons typically list symptoms such as pain, implant rupture, and shortness of breath to convince the insurance company that surgery is medically necessary.

Some women have chosen to pay out-of-pocket for implant removal because their chosen plastic surgeon does not accept insurance or is not in their insurance's network.