There’s plenty of online chatter about whether breast implants can make patients sick. Many of us, including potential breast augmentation patients and those who already have breast implants, are turning to plastic surgeons for answers. But while clinicians can confidently address some of what people see and hear on the news and internet about breast implant safety, there is a lot that remains in a grey area, leaving plastic surgeons conflicted about how to respond to consumers’ concerns.
Cancer and other breast implant related illnesses have become a major topic of discussion in plastic surgery societies and between patients and their plastic surgeons, according to Tim Sayed, MD, a plastic surgeon with practices in La Jolla and Newport Beach, Calif. Dr. Sayed predicted that safety concerns about breast implants would continue to snowball in 2020 in the Nov/Dec feature: “A Year in Review: Taking a Look Back at 2019
and A Look Forward to 2020.1
“There are a couple different issues that need to be unpacked when we talk about implant safety,” Dr. Sayed expressed. “First is that there has been a recall by Allergan of their textured breast implant devices, which use a type of texturing technology called Biocell. Biocell has been associated with a rare form of lymphoma cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in around 900+ patients worldwide.”
Allergan adhered to the FDA recommendation to pull these implants from the global market.
“Now we are seeing patients who have no symptoms of any concern, but are nonetheless worried that they might develop this rare form of cancer, and thus would like to have their implants removed,” Dr. Sayed reported.
Plastic surgeons are also seeing patients with increasing frequency who present with clusters of various symptoms, from blurry vision and lethargy, to depression and memory loss – a malady informally called Breast Implant Illness (BII).
“This really represents a grab-bag of nonspecific constitutional, rheumatologic, endocrine, gastrointestinal, dermatologic and other symptoms,” Dr. Sayed indicated. “Many of these patients are very debilitated and they have gone through pretty comprehensive workups to try to identify other causative factors, often seeing multiple doctors without really finding an answer.”
Patients with those symptoms are con- cerned that their breast implants may be to blame. However, this concern is not yet backed or refuted by science.
“Although we do not have any good scientific data or pathways to correlate these symptoms to the presence of implants (or to the presence of the capsule of tissue that forms around the implant), there is a strong impetus on the part of these patients to get these devices out, and many of the patients who undergo removal start to feel better after explantation,” Dr. Sayed noted.
According to plastic and reconstructive surgeon Charles Galanis, MD (Beverly Hills, Calif.), science and action to identify and remove the offending implants have somewhat quelled the concern among potential breast augmentation patients about cancer risk. But BII remains a big worry among people that have implants and those interested in breast augmentation surgery.
BII is a difficult and grey area to navigate with patients, Dr. Galanis maintained.
“It is something that continues to be investigated by the scientific community and in the literature. We have not yet found a cause-and-effect link between breast implants and some of the symptoms that a small percentage of patients are presenting with and attributing to their implants,” Dr. Galanis stated.
Despite the probability that BII is rare and unproven, there is a groundswell of grassroots efforts to bring attention to this issue and discuss it on social media. Concerns about implants and illness are widespread causing anxiety and, in some cases, misinformation.
The Breast Implant Illness and Healing by Nicole Group on Facebook boasts nearly 105,000 members. Researchers analyzing Google Trends for relative search volumes of “breast implant ill- ness” from February 2018 to 2019 found an exponential increase in searches, according to a viewpoint published in January 2020 in Plastic and Reconstructive Surgery.2
RealSelf recently reported breast aug- mentation was the most researched surgical treatment in 2019, while breast implant removal searches climbed five spots, from the 16th most searched surgical procedure in 2018 to number 11 in 2019.3
The impact on demand
According to Fort Collins, Colo.-based plastic surgeon Diane Duncan, MD, demand for breast implant surgery is down.
“I have seen about a 50% reduction in consultations for breast augmentation. Of course, I do not hear from the patients who do not come into the office as to why. I believe part of the issue is that large breasts are falling out of fashion, and the health concerns are a factor as well,” Dr. Duncan declared. “In the 1990s, when the FDA banned the use of silicone gel implants, there was a similar slowdown. Then removal of gel implants and replacement with saline was a trend.”
Now, more patients are considering outright implant removal, Dr. Duncan continued.
However, it is not yet clear whether BIA-ALCL and BII concerns have negatively impacted U.S. consumer demand for breast augmentation surgery.
“I think that is going to bear out in the next year or two when we see data from the various societies that track that information,” Dr. Galanis speculated.
Recent statistics don’t yet suggest an impact. The American Society of Plastic Surgeons’ (ASPS) 2018 statistics – the most recent data available – show that demand for breast augmentation rose 4% from 2017 to 2018. Moreover, breast augmentation has been the top cosmetic surgical procedure since 2006, according to ASPS.
Addressing patient concerns
Plastic surgeons say they have encountered concerned patients and transparency is key.
“Many plastic surgeons are grappling with the best way to respect these patients’ concerns, work with those who want to have their implants removed, while at the same time not adding unnecessary paranoia or panic around implants in general,” Dr. Sayed pointed out.
Dr. Galanis approaches the topic with worried implant patients with empathy, honesty and an open mind. He acknowledges that there is no scientific evidence that implants are the cause of patients’ symptoms. He also feels that it is conceivable that, in a small percentage of patients, there is some sort of reaction to the implant that results in symptoms.
“We have to be open to the fact that this is possible for these patients,” Dr. Galanis acknowledged. “Furthermore, I think that for patients coming in who have had these symptoms and have exhausted every other diagnostic avenue, there is something to be said about peace of mind if they want their implants out and to remove them.”
When patients ask about BIA-ALCL risk or have concerns, the conversation is more straight-forward. “There is more of an understood and studied phenomenon,” Dr. Galanis confirmed. “It is more directly attributable to a particular kind of implant that many providers in the U.S. don’t even use. Because of that it is not as much of a grey area. It is an avoidable issue based on your implant selection.”
Dr. Galanis explains to patients that BIA-ALCL is a disease that is exclusively attributed to textured implants and in the majority of those cases it is attributable to a specific kind of implant that is no longer on the market. If they are using smooth implants, the risk approximates to zero.
Still, BIA-ALCL remains a realistic con- cern for patients who have textured implants, Dr. Duncan noted. “Part of the challenge is that the implant industry has invested millions of dollars in making textured implants and does not plan to take them all off the market.
“I’ve never used textured implants, but my colleagues do,” Dr. Duncan continued. “I had a recent case of ALCL, only two years after Sientra textured implants were placed by a colleague. More and more patients with textured implants are seeking to exchange for smooth implants or desire a simple removal.”
As of now, the FDA does not recommend implant removal for patients with Allergan Biocell breast implants who do not have symptoms. But patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, according to FDA.gov.4
Dr. Duncan believes patients come to her based on trust and her 30 years’ of experience. “I have the reputation of speaking directly and honestly with everyone. I can assure my patients that they will not get ALCL with smooth- walled implants.”
Breast Implant Illness is harder to define but seems rare, Dr. Duncan maintained. She has seen only one case of what she would consider BII, nevertheless, the goal for plastic surgeons should be to arm patients with credible information and let them decide, she stated.
“I feel the operation is safe or I would not perform it,” Dr. Duncan continued. “I do not do Brazilian buttock surgery as safety is a big concern. I do not try to push people into breast augmentation; it must be a self-driven decision.”
Do patients get better after removal?
Dr. Galanis has removed breast implants in a small percentage of patients concerned about BII. In his experience outcomes are mixed.
“That is probably echoed in my conversations with colleagues around the country. A lot of patients do experience improvement in their symptoms, but then there are others that all their symptoms do not go away,” Dr. Galanis asserted. “It is very difficult to predict who will be a responder and who will not. I tell patients that implant removal is not a guarantee that their symptoms will improve.”
Dr. Duncan had one patient who wanted her implants removed due to concerns about BII, and she made a significant recovery from symptoms of fatigue and depression following implant removal.
“For some who believe their symptoms are from BII, surgery to remove the implants may represent a sort of diagnostic procedure to identify if they feel well after explantation of the devices,” Dr. Sayed stated.
“There is no non-invasive or nonsurgical test to ascertain if removal of the implants and capsules will help them feel better. The removal is the test, in a way,” Dr. Sayed conceded.
Staying the course, for now
Dr. Galanis sees no need to change his approach to breast augmentation because it remains a relatively safe procedure that, for the most part, positively impacts patients’ lives.
“The first and most important thing is making sure patients are fully educated on all the risks, fully informed on what the available literature shows, but also acknowledging that there may be other issues such as BII, which have not yet born out in the literature,” Dr. Galanis emphasized.
Dr. Galanis, who does a lot of body contouring with liposuction says fat grafting of the breast is often an option for his patients, but fat is not an ideal substitution for breast implants.
“Today, we cannot quite achieve the same results with fat that we can with implants in terms of predictability, quality and the size of the augmentation,” Dr. Galanis reported.
It is important to continue research on BII and to continue to be there for patients, according to Dr. Galanis. But it is a balance.
“Breast Implant Illness appears to represent a very, very small percentage of patients,” Dr. Galanis continued. “There are other risks from breast augmentation surgery that are probably far more common than BII. I think it is important to talk with patients about that and let them know it could be a real entity, it is out there, and we are looking at it, but I don’t think we need to contribute to a hysteria that everyone is going to get BII.
Currently, it is just not the case. The vast majority of people are happy with the surgery, they are healthy and they are doing well with an improved quality of life.”
Hilton, L. (2019). A Year in Review: Taking a Look Back at 2019 and A Look Forward to 2020. The Aesthetic Guide Nov/Dec 2019: 62 – 70. Print. Available at: https://www.aestheticchannel.com/year-review-tak- ing-look-back-2019-and-look-forward-2020
Adidharma, W., Latack, K., Colohan, S., Morrison, S. and Cederna, P. (2020). Breast Implant Illness: Are Social Media and the Internet Worrying Patients Sick? [online] Available at: https://journals.lww.com/plasreconsurg/ fulltext/2020/01000/Breast_Implant_Illness__Are_ Social_Media_and_the.96.asp
Realself News. (2019). The Most-Researched Cosmetic Treatments of 2019. [online] Available at: https://www.realself.com/news/ most-researched-cosmetic-treatments-of-2019
U.S. Food and Drug Administration. (2020). FDA is- sues safety communication on Textured Allergan Breast Implants. [online] Available at: https://www. fda.gov/medical-devices/safety-communications/ fda-requests-allergan-voluntarily-recall-natrelle-bio- cell-textured-breast-implants-and-tissue