Breast implant surgery is the most popular of cosmetic surgeries and nearly 300,000 women undergo the procedure each year.
About a third of them are breast cancer survivors.
There’s been a growing concern around implants and autoimmune disorders, even the possibility that the implants are causing cancer.
We’ve done several stories on Jill Stutin-Gresham and her breast cancer and ovarian cancer journey in the past fifteen years. When first diagnosed she underwent a bilateral mastectomy and reconstruction surgery that included silicone breast implants.
“I'd just been diagnosed with breast cancer, I wasn't thinking the implants are going to hurt me,” she said.
A decade later, she needed new implants and once again the smooth sided silicone type was implanted.
Then last summer, she became very ill.
“I had severe gastrointestinal problems and could not keep even water down, I was in the emergency room five to six times a week being rehydrated and given medication,” she said.
Her primary physician was at a loss for the cause so he recommended she see several specialists. About fourteen in all. Eventually she was diagnosed with an autoimmune disorder and several other possible causes were discussed as well, but nothing could explain the vast type of symptoms she was experiencing. Symptoms so bad she eventually became practically bedridden.
Her father sent her an article about Breast Implant Illness and Jill started doing research. She found a Facebook group with nearly 85,000 members.
“I was blown away with women going through exactly what I was going through,” Jill said.
Her illness eventually cost her job and soon she’ll lose her insurance. She wants the implants removed, but only a couple of the physicians she has seen believe her problems are being caused by her implants and neither are surgeons capable of the operation.
And then there’s the cost, “Insurance has been fighting me every step of the way,” she said.
At issue is the fact that there is no test, no definitive diagnosis and women self-identify with the symptoms.
“I can't even drive anymore because of my brain fog and exhaustion,” Jill said.
But she’s encouraged by stories of women who’ve had their implants removed and their symptoms eventually reverse.
At an FDA hearing in March, the main focus centered around what doctors say is a link between textured breast implants and a rare form of lymphoma, called “Breast Implant Associated ALCL." It’s a cancer of the immune system that grows in the scar tissue surrounding the implant.
As of Sept. 30th of last year, 457 women in the U.S. have been diagnosed either after reconstruction after mastectomy or cosmetic surgery. The majority of women with the cancer had textured implants but the FDA says there are cases of smooth surfaces and still more cases where the type of implant isn’t known. The American Society of Plastic Surgeons reported sixteen disease related deaths since the beginning of the year. Cases of Breast Implant Associated ALCL generally occur eight to ten years after women first get the implants.
Meanwhile, plastic surgeons and manufacturers say the implants are safe and despite other countries, including Canada, banning them, the FDA decided it would not. Instead it will collect and disseminate information about the risks.
There is one plastic surgeon in Ohio who has been at the forefront of this issue and has performed thousands of implant explantations. Dr. Lu-Jean Feng has been studying the issue as well and plans to present finding to her colleagues. The procedure is so popular that it has basically taken over her practice and she’s booked far into next year.
Jill is now trying to raise money on her own through a Go Fund Me page to cover her medical expenses and hopefully get a chance at surgery.
“No one knows what it's like to feel like this every day, I mean I've totally lost quality of life,” she said.
Click here for more info on Breast Cancer Illness. We've also included some FAQ and talking points for surgeons from The American Society for Aesthetic Plastic Surgery
Q: What is Breast Implant Illness (BII)?
A: 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 related to social media. There is one Facebook group alone with more than 50,000 members, all of whom report Breast Implant Illness (BII) symptoms. This is not to say that social media is the cause of Breast Implant Illness (BII) however, it may account for the rapid increases in patient reporting. BII is not an official medical diagnosis.
Q: Is there a link between medical grade silicone implants and any disease?
A: 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.
Q: Are there any tests that would indicate a connection between breast implants and symptoms that are being labelled Breast Implant Illness (BII)?
A: There is no diagnostic testing specifically for Breast Implant Illness (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.
Q. Is there any scientific data showing causation between implants and these symptoms or any disease entity?
A: 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.
Q: Does implant removal improve patient’s symptoms or cure a patient who has a medically diagnosed disease entity like an autoimmune disease?
A: 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.
Q. What are ASAPS and ASERF doing to better understand this group of systemic symptoms being called Breast Implant Illness (BII)?
A. Because there are many women that self-identify as having Breast Implant Illness (BII), we are listening. ASAPS 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.
Q: What should a physician do when a patient complains of Breast Implant Illness (BII) symptoms?
A: Doctor should not ignore your patient’s concerns. Their symptoms are real and whether or not they can or cannot be attributed to their implants isn’t relevant since there is simply no existing way to prove nor disprove causation or association. Options can 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. Patients who present with concerns of Breast Implant Illness (BII) have real symptoms that often cannot be categorized into any specific know 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.
Q: What is the risk of developing Breast Implant Illness (BII)?
A: 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. 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.
Q: If after the discussion of risks and the possibility of no improvement of symptoms post-explantation is discussed with a patient, what should be done if the patient demands an “en bloc” or “total” capsulectomy with their explantation?
A: 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. Rather than react, first discuss the reasons you would perform a total capsulectomy with any patient. Not all plastic surgeons routinely perform a capsulectomy with explant, but some do. If you wish to perform capsulectomy on a patient, it is important to explain that 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. Explain what size incision is necessary for an en bloc (as many may not be aware of how large an incision may be necessary). If they had an axillary approach or periareolar approach for breast implant placement, it must be explained to them that they cannot have the procedure done through those incisions. It is recommended to reinforce that there are increased surgical risks associated with en bloc capsulectomy which requires a complete dissection of all the tissues surrounding the breast implant and, that we do not have enough collective data to guarantee any improvement in their symptoms they have labelled Breast Implant Illness (BII).