Posted August 13, 2019 in Breast Implant Illness
At Stephens Plastic Surgery, we care about our patients’ wellbeing. Therefore, it is imperative that we provide the most accurate and current scientific information available regarding breast implant safety. Here, we provide information about a syndrome of silicone breast implant illness termed “Breast Implant Illness,” or BII.
There has recently been a lot of discussion about this disorder in the media, especially on social media following the most recent Food and Drug Administration (FDA) hearings on breast implants. There is presently overwhelming evidence to support the safety of silicone breast implants. That said, we support the women’s decision to obtain, keep, or remove their breast implants.
We believe that the greater community of board-certified plastic surgeons support ongoing studies regarding breast implant safety and working with the FDA towards the best interests of their patients. Our office is participating in reporting our breast implant outcomes with our professional societies that are working with the FDA.
After all, as doctors, we are sworn to follow the Hippocratic Oath: “first, do no harm.” It also states “with the best of our ability, to respect and follow the scientific gains of those physicians in whose steps we walk and gladly share such knowledge.”
Over the years, and particularly in the past ten to fifteen years, breast implants have become safer through improved shell and barrier designs and better cohesive gel materials; however, the basic molecular structural components of silicone implants have not really changed.
Annually, over 300,000 women have breast implants in the U.S. alone as well as 100,000 implant-based, breast reconstructions.
What Is the Science Regarding BII?
The current body of scientific evidence shows that there has not been any “evidence-based” or “peer-reviewed” data to support the syndrome of BII. Silicone breast implants were approved by the FDA in 1962 and have been extensively studied for adverse outcomes. Still, there has been controversy regarding their safety with reports of various health conditions associated with breast implants.
In fact, in 1992, the FDA removed silicone gel implants (but not saline implants) from the market due to the lack of data from the manufacturers. The FDA required implant manufacturers to provide “core studies,” to assess breast implant safety protocols.
Following this, The Institute of Medicine, a neutral scientific review body, concluded in 1999 that local complications were the primary concern of breast implants but further studies were necessary to assess systemic disease and any relationship to breast cancer.
Gel breast implants were re-released on the market, and, since then, an extensive amount of clinical studies and research have been conducted. Despite this, however, silicone or breast implant illness, BII, has been found to have no clear definition or disease marker and continues to describe a variety of conditions that some women have attributed to their breast implants.
What Are the Symptoms of Breast Implant Illness (BII)?
Regarding social media and BII, one Facebook site has 70,000 members who have self-reported BII. These women believe that silicone and saline implants are connected to their illnesses. This may reflect a growing awareness of these symptoms. The symptoms described by these members are noted below. As you can see, there is a “catch-all” spectrum of illnesses and symptoms:
- Skin rashes, disorders, and sensitivities
- Chronic fatigue
- Heart and kidney problems
- Hair loss
- Multiple sclerosis-type syndrome of various neurologic symptoms and conditions
- Brain fog
- Chronic muscle and/or joint pain
- Hormonal changes
- Anxiety and depression
- Sleeping problems/insomnia
- Digestive disorders
- Breathing and lung issues
- Kidney diseases
You can see above that there reports on diseases and symptoms involving just about every organ system.
Is There a Test to See if You Have Breast Implant Illness (BII)?
There is no current test to identify or diagnose BII. However, you should contact us and see a rheumatologist if you have any of these symptoms to assess if you have any autoimmune markers to confirm or rule out autoimmune disease.
Although no firm connection between silicone implants and immune disorders have been made, this doesn’t mean that you do not have an autoimmune disorder. These conditions typically occur in women in their 30s and older.
To date, there is no association between silicone implants and any tests or markers to conclusively establish a cause and effect that connects them with any disease or disorder. The research arms of our plastic surgery societies are actively investigating and requesting that member plastic surgeons contribute to ongoing surveillance of breast implants and participate in these studies.
What About Just Removing My Implants if I Have Any of These Symptoms?
We are seeing an increasing number of women who are requesting a consultation to have their implants removed. They often have excellent cosmetic results that have held up wonderfully through the years and are regretful that they feel that they should remove their implants; but their symptoms are forcing them to consider this.
The difficulty is that there is very little research to indicate that removing breast implants will improve symptoms. Anecdotally, some women’s symptoms do improve, some temporarily and some permanently, but some will not. The difficulty is that knowing which ones will improve and which will not is unpredictable.
There are some very vocal advocates who wholeheartedly recommend that all women with BII symptoms remove their implants. This, and the strong commercial driver that advocates implant removal but not to participate in scientific studies, represents a missed opportunity to learn more about the connection between breast implants and BII.
In that conviction against breast implants, an industry of para-medical and medical professionals and surgeons has spawned that are cashing in on the “breast implant removal bandwagon.”
Unless we do good sophisticated, methodical studies to provide a better understanding of the treatment of BII, these voices will drown out scientific progress and reduce the trust in those very institutions and individuals that want to help and support of all of our patients. We need to untangle these entities through a robust research arena to better define BII and how to treat it.
We suggest that you have a thorough physical exam by a qualified physician and have blood tests to check for autoimmune disease or inflammatory conditions. Genetic tests are being proposed to see if perhaps gene mutations may predispose some women to BII, but which tests and how to proceed with this is still uncertain.
There is the hypothesis that it is not the implants at all, but that very small numbers of difficult to detect bacteria around the breast implants may be causing these symptoms. There may be a new battery of tests to confirm this possibility.
So, What About Removing My Implants?
We support any woman who feels she should remove her breast implants. We recommend the above studies and also possible genetic sequencing for bacteria in the breast capsular tissue and pathology.
We also recommend that we follow your progress for two years so that we can submit data to the ongoing studies. Breast implant illness needs to be taken seriously and treated appropriately.
What About En Bloc Capsulectomy? Should I Have This When Some Individuals and Surgeons Are Recommending It?
“En Bloc” refers to the removal of the breast implant together with the surrounding capsular tissue as one unit; in one piece, all together. This term is used in the surgery for cancer that removes the tissue in its entirety.
In cancer surgery, this is important because we don’t want to leave any possibility of cancer behind. In fact, in breast cancer surgery such as lumpectomy, the tissue is sent to the pathologist to make sure that there are adequate margins of normal tissue around the cancer.
Also, in the case of broken implants when the silicone is now out of the implant but within the breast implant capsule, removing the capsule along with the implant makes sense to prevent any spillage. In many cases, the older calcified capsules are reliably removed with the implant.
But reliably removing the capsule, “en bloc” can be a difficult, if not an impossible procedure where the capsule is tightly adherent to the ribs. It risks damage to the tissue around the ribs and possibly creating a hole in the chest wall and producing a pneumothorax.
To risk damaging these structures doesn’t make sense when there is no benefit to the patient. Medicine is a risk/benefit endeavor. Recently, our professional society sent an advisory stating that doing “en bloc” procedures are not superior to precise capsulectomy or more limited forms of capsulectomy.
Frankly, surgeons that say that they always perform “en bloc” capsulectomy are being disingenuous, to put it generously! As a surgeon, it’s unclear how any other surgeon can do this potentially risky procedure in every patient.
Dr. Stephens has always performed “total precise capsulectomy” when removing intact silicone and saline implants to allow the tissue to collapse back together and not risk the possibility of seroma fluid collections or future infections due to fluid accumulation.
Where it’s possible to do a clean atraumatic, dissection around the implant, he will perform an “en bloc” procedure. In cases where the implant is very large and one can’t see completely around the implant without multiple or extremely large incisions, he will dissect around the implant as far as possible and then remove the implant from the “freed up capsule” that is now separate from the patient, and then proceed to remove the rest of the capsule.
Even in cases where the implant is broken, with careful and precise surgical technique, the free gel will be completely removed from the patient.
Among the Breast Implant Illness Advocate Community, there is the idea that only “en bloc” removal of the breast implant and capsular tissue is sufficient; that all breast implants, including intact implants, should be removed this way.
This is a mistaken notion and a very risky proposition. I am aware that there are surgeons that state they always do this potentially harmful procedure. Frankly, they are preying on fearful women who believe that any other procedure will leave them at risk for continued symptoms.
There is nothing between an intact implant and the capsular tissue. It is empty space. If there is fluid in the implant pocket, then the fluid and the capsular tissue should be sent to the pathologist for evaluation of BIA-ALCL.
What Can We Do for You if You Have These Symptoms?
We empathize with any woman who has symptoms and is questioning if she has BII; it can be a scary situation. We take your symptoms seriously, and we understand the self-doubt and possibility of ridicule from all sides: spouses and family, news, social media, medical professionals, etc., and we hope that this discussion will help to sort out some of your questions.
If you need further clarification regarding BII, we recommend contacting us by email or phone or by scheduling an appointment to see Dr. Stephens.
We are aware there are individuals and groups that are creating fear among women and feel that breast implants, whether for cosmetic enhancement or reconstruction, should be completely banned.
These fearmongers do not help women to make rational and healthy decisions but only add fuel to women’s worst fears. We want to provide answers to the best of our ability. Only good medical care and ongoing research are going to work towards good answers to this.
We are advocates for women’s health and well-being and our professional plastic surgery societies, ASAPS and ASPS and their respective research arms, PSEF and ASERF are serious about the further understanding and studying BII in order to help all of us care of our patients. Many within our societies’ leaders include women, some whom have had cosmetic augmentation and implant reconstructions themselves.
We recommend that if you have concerns and symptoms of BII that you be seen in our office. We understand that you are having real symptoms. There are local implant complications such as capsular contracture and implant displacement that can affect the whole upper body and may aggravate underlying conditions.
Systemic conditions should be evaluated by knowledgeable and competent specialists where appropriate: for example, a dermatologist for a skin condition or an ophthalmologist for conditions of the eye. A thorough examination, as well as recommended imaging and laboratory studies, can be performed. Your primary care physician and rheumatologist can help to rule out known immune disorders. After review, and with further understanding, together we can consider if implant removal is in your best interests.
Regarding implant removal, Dr. Stephens has always performed this together with precise atraumatic capsulectomy or “en bloc” capsulectomy when it can be safely done. Explantation and capsulectomy can be performed alone or where appropriate, combined with a breast lift using your existing breast tissue as it’s own implant as an auto-augmentation where there is adequate breast tissue.
There is also the option of using your own fat that is removed and placed in your breast following some preparation of the breast tissue pre-operatively to optimize your results.