BIA-ALCL UPDATE

April 15th, 2019 | Categories: Breast, Plastic Surgery

I would like to take this opportunity to discuss an emerging trend called BIA-ALCL. There is an uptick in reports of a certain type of cancer, a form of lymphoma that occurs in women who have had breast implants. News of this new form of cancer has caused outrage in some women, sadness, fear and disappointment in others. There’s no doubt that this issue deserves attention, and even media attention, but I think there has been some irresponsible journalism that may be generating unnecessary fear, concern, and even surgery. I reviewed my own breast implant data in my practice over the past 4 years. I placed breast implants for reconstructive purposes in 30% of cases and cosmetic purposes in 70% of cases. When I used the implants for reconstruction, I first placed a tissue expander first in 90% of those cases. In cosmetic surgery, 70% of the cases I performed were primary and 30% were revision surgeries. Of the primary breast cases that I performed, I used shaped implants in 30%. In revision surgeries, I used textured implants 60% of the time. What do all these numbers mean? Considering I used textured implants in 100% of my reconstructive procedures, and for every shaped implant used in cosmetic and revision surgery, well, half the implants I’ve ever placed have been textured. So what does this mean for the 200 women I have treated over the past 4 years who now have textured breast implants? And what does this mean for the women who seek my expertise for complex breast augmentation revision, correction, anatomic or teardrop implant placement, and reconstruction? Are these patients at undue risk for a type of cancer attributable to textured implants? To answer these questions, I have performed a thorough review of the most up-to-date literature and made a special effort to avoid recommendations and data provided by industry. After carefully reviewing all the present data, I continue to routinely perform breast surgery using textured devices. This is because I believe they are superior in certain circumstances for treating conditions and addressing patient desires that would be less optimal with the use of a smooth implant. And the reported risks, although they deserve recognition, do not outweigh the benefits of textured devices in carefully selected patients.

What is BIA-ALCL?

It stands for breast implant-associated anaplastic large cell lymphoma. It is a form of non-Hodgkin’s lymphoma. It does not qualify as breast cancer. It is curable in the majority of cases with removal of the implant and its investing capsule. In rare cases, the disease can metastasize and require chemotherapy. Even rarer cases, it can lead to death.

What does BIA-ALCL look like?

I have never seen a case of BIA-ALCL in my own practice. I have seen seromas and patients have been referred to me to rule out this disease. According to the literature, BIA-ALCL presents as a fluid collection or mass surrounding a breast implant. It usually occurs up to eight to ten years after implant placement, and this speaks to the indolent nature of this disease. Early detection of this disease is imperative. Because the description of BIA-ALCL resembles seroma, which is a relatively common and benign fluid collection that is curable, there should be no need for alarm if such a collection or mass occurs early after implant placement in the absence of other symptoms. However, evaluation by an expert whenever this is suspected is indicated. The next steps include ultrasound imaging to get a better sense or the nature of the fluid collection or mass, and biopsy or aspiration of the mass or fluid collection. Studies called CD30 and cytology will help better qualify the nature of the fluid collection and will diagnose the disease. Therefore, BIA-ALCL is not a clinical diagnosis but a pathological one. An educated surgeon will direct a case that is clinically suspicious for BIA-ALCL to an appropriate specialist.

Is BIA-ALCL curable?

Yes. With appropriate follow-up in early detection, most cases of BIA-ALCL are curable with implant and capsule removal. In many cases a new implant can be placed safely. However, it is important to be aware that there have been reports of death associated with BIA-ALCL. There is a sidebar in these reports that the patients who died from BIA-ALCL never underwent implant removal or capsulectomy, and the disease was diagnosed and treated late in its course. If appropriate awareness of the disease and followup occurs, after early diagnosis it is likely that you will be cured with implant removal and capsulectomy alone. Total capsulectomy, also known as en bloc capsulectomy, is necessary to eliminate the risk of disease persistence or recurrence. This can safely be performed by any board-certified plastic surgeon. In some cases chemotherapy may be necessary, but in most cases a single operation will be all that was necessary.

What is the incidence of BIA-ALCL?

After reading 12 qualified articles without industry affiliation, including FDA press releases, and speaking to colleagues whose practices are exclusively based on breast surgery, the one thing I am certain about is that we do not know the true incidence of BIA-ALCL. 10 years ago, it was thought that 1 in 80000 women with breast implants would develop this disease. 5 years ago the estimate shifted to 1 in 30000. More recently, systematic reviews have estimated that this can occur in more than one in 3000 women with a particular type of implant. I have spoken with many colleagues about this, and only one plastic surgeon has seen this disease in one of his patients. His practice is exclusively cosmetic and reconstructive surgery of the breast. Again, to date, I have never seen a case of this. However, 65% of my practice is non-breast surgery, I am young, and many of the textured implants I placed are less than three years out. I do not, and would not ever underestimate the seriousness of this disease. However, I am reassured that the incidence of BIA-ALCL remains exceptionally low – even if a low reported rate of disease is attributable to a lack of understanding, a lack of awareness, and fear of repercussions should surgeons report their incidence of disease. I also think that it is in industry’s best interest to under-report the importance of this illness- so I keep that in mind as well.

What are the risk factors for BIA-ALCL?

At the time of this notice, BIA-ALCL occurs in women with breast implants. It can occur in women with both silicone and saline devices. There may be a genetic predisposition as well. For example, South Korean women make up one of the largest markets, even if the nation is somewhat new to breast augmentation. Despite being one of the highest users of breast implants, including textured devices, very few reports of BIA-ALCL in Asian women exist. In reports that have documented the type of implant used, it appears that textured implants are associated with BIA-ALCL. To the best of my knowledge, very few if any smooth implants have been explicitly implicated in the development of BIA-ALCL. The only exceptions are women with smooth implants that replaced textured implants. That said, a history of textured implant breast augmentation or reconstruction is the biggest risk factor for BIA-ALCL. The type of texture and the manufacturer of the implant also affect the risk of disease. The most up-to-date literature suggests that the size of the texture, or porosity, is directly related to the risk for BIA-ALCL. Implants that are “macro-textured”, with a large pore size, are associated with the highest incidence of reported BIA-ALCL cases. In the United States, Allergan (Inamed) devices that are textured fall into this category. The Biocell processing technique used in Allergan textured round and shaped breast implants, as well as tissue expanders, fall into this category. Other implant manufacturers like Sientra and Mentor use a smaller texture on their implants. Think of it as a fine grit versus coarse grit sandpaper. The finer the grit, the less chance of BIA-ALCL developing. Over the past year, I have shifted to the use of Sientra implants for this reason. In breast reconstruction cases, I still use Allergan products. I am slowly converting to Sientra instead, although I do not think the Allergan products are in any way faulty or put my patients at undue risk. In fact, my breast reconstruction patients have some of the best cosmetic results I’ve seen, so it is difficult to make the shift without more information. Fortunately, I am equally thrilled with the results I am achieving with analogous Sientra devices. Today, only two cases of BIA-ALCL occurring after Sientra implant placement with textured surfaces have been reported. I am very aware that there may be more and there may be reporting bias, but this incidence remains acceptably low for me to use this device inappropriately selected patients after educating them.

Why used textured implants at all if there is any risk of BIA-ALCL formation? Why not use smooth implants all the time?

Textured implants have been around almost as long as breast implants have been around. As early as the 1970s, it has been understood that a textured or porous surface reduces the risk of another complication called capsular contracture. This is because the textured or porous surface allows for “disorganized” encapsulation by the surrounding tissue. Smooth implant causes a wall of naturally occurring capsule to form around it. If the implant is smooth and its surface is uninterrupted, that scar layer has the potential to contract in a way that causes the implant to become tight and painful. We’ve all seen and heard about capsular contracture. Although it is not life-threatening, it is unpleasant and we will take all efforts to reduce this nuisance complication. This appropriately gave rise to the textured device in the 1970s. Back then, textured implants had a 2 mm polyurethane coat around them. They were very porous, like a very coarse grit sandpaper. But there was concern that the polyurethane material might be carcinogenic. That’s why you don’t hear of this type of implant anymore in the United States. Although systematic reviews show results that are dubious, conventional wisdom states that textured implants do mitigate risk of capsular contracture- even if the percent or risk reduction is in the single digits. I am compelled to use them in recurrent and symptomatic capsular contracture cases for the peace of mind that I am doing the best for my patients. Having said that, I can think of at least one or two patients that I treated for capsular contracture that had a recurrence with textured devices. Weighing all risks and benefits, I currently recommend a micro-textured breast implant such as a Sientra or Mentor textured device for these patients. It is very important that patients be fully aware of the risks and treatment of BIA-ALCL prior to undergoing this type of surgery. Thoughtful discussion with a caring and board certified plastic surgeon is far more valuable than what you may read in tabloids, Facebook posts, and pamphlets. I also use continue to use textured implants in every implant-based breast reconstruction I perform. The expanders I use during the first stage of breast reconstruction are shaped and textured. The texture is designed to prevent expander migration and displacement. Also, because of the nature of the wound bed it is thought that these textured expander devices reduce the risk of capsular contracture. Once these expanders are removed, the majority of my prosthetic – based breast reconstruction patients will have a shaped cohesive gel implant placed into the pocket. When all breast tissue has been removed, an anatomic, or shaped, or teardrop-shaped implant will create the most realistic-looking breast. When a shaped implant is used, there is a concern of implant rotation and migration. Because shaped implants are not circle-shaped, but oval-shaped, it is imperative that precise implant placement and retention of that position are maintained. Although smooth anatomic implants may be available, I have never personally use them nor seen them used by my colleagues. The same goes for certain cosmetic situations. In women with very small breasts, the situation is similar to mastectomy in that the shape of the underlying implant is more likely to be seen in women with naturally occurring breast tissue that could possibly conceal the shape of the implant below. Other women prefer a naturally appearing large breasts. In these cases it may be easier to achieve that goal with an anatomic or shaped implant than with a round implant. Again, because there is a realistic concern of implant migration and rotation, most plastic surgeons prefer a textured surface when a shaped device is used. Finally, women may present with what is known as pectus excavatum. This can be a challenging condition to correct, that leads to breasts that point towards each other and possibly touch in the midline. Before implants are placed, or when they are removed, it becomes very apparent that the rib cage faces inward. There may be an oval shaped valley over the position of the heart. As you can imagine, implants- especially large ones, will have a tendency to fall down the peaks into that valley. Clinically, this manifests as breasts that touch each other, but this does not necessarily qualify as symmastia. It has been shown that the use of carefully positioned and anatomic breast implants with the narrow part of the teardrop facing inward can both address the underlying chest wall shape and correct the chest wall deformity that is often seen in these patients after implants are placed. In these patients, it is in our best interest to select a textured device, because the risk of malrotation can compromise not only the cosmetic outcome of the breast but the overall chest wall shape. In these patients, as well as others, I will continue to offer textured implants until sufficient data exists that compels me otherwise. Of course, I have this very conversation with every single patient prior to selecting such implants.

Why does BIA-ALCL occur in the first place, and why in textured implants? Why is it that implants with a coarser grid are associated with a higher risk of this disease, and those with a finer grit and smooth implants are associated with a near-zero incidence?

It is not perfectly understood why this happens, but the fact that it does may shed light on the disease itself and how to prevent it. There are a lot of thoughts about this and leading experts suggest that it comes down to surface area. Implants with higher surface area have a higher chance of causing BIA-ALCL. This has been well demonstrated in the literature. Implants with a macro-textured surface such as polyurethane or Allergan implants have a higher surface area than implants with a finer texture such as those manufactured by Sientra and Mentor, and a much higher surface area than smooth implants. Let’s accept, for now, that surface area is directly proportional to the incidence of BIA-ALCL. In my opinion, micro-textured implant surfaces such as those seen on Sientra devices, as well as smooth implants, confer a sufficiently low risk of a disease that is treatable that I am still compelled to use them in my practice without much hesitation. Based on all of the information that is available I will still offer textured implants to be used in my practice. This includes Sientra, Mentor, and Allergan devices. Of course patients should be fully educated on the potential risks of disease. If they are still concerned and worried I will use a smooth device in any woman who requests a smooth device. Of course, they will also be counseled on the risks of a smooth device in certain circumstances.

Why does a larger surface area result in a higher risk of BIA-ALCL?

For one thing, more surface area equals more investing capsule. Perhaps the fact that a larger capsule exists may explain the higher incidence of disease. A more likely possibility is that the textured devices, especially those with a coarser grit, are more likely to carry and maintain a larger bacterial burden upon placement. Many leading experts believe that bacterial burden is the underlying cause of BIA-ALCL. That bacteria can cause naturally occurring white blood cells to convert to a diseased state, that colonization of bacteria is really what causes BIA-ALCL. Accordingly, the same experts are proponents of strategies that minimize the possibility implant colonization by bacteria to minimize the risk of BIA-ALCL. I have always practiced a technique known as the “14 point system” that is designed to ensure best practices and reduce the risk of bacterial colonization. This system includes strategies like covering the nipples with occlusive gauze, using the inframammary approach instead of the peri areolar or axillary approach when possible and indicated, and ensuring the utmost in sterile technique. Also, avoidance of dissecting through breast tissue that exposes an implant to bacteria that are naturally occurring in breast ducts, changing gloves before touching an implant, using a Keller funnel and a so-called no-touch technique, preoperative and postoperative antibiotics, and other strategies are outlined in the system. I was trained to do every single step of this so-called “14 point system”, so I was not surprised when it gained popularity as a measure to reduce both capsular contracture and accordingly BIA-ALCL. In other words, the same maneuvers that reduce the risk of infection also reduce the risk of BIA-ALCL, since the underlying cause is theoretically the same for both.

What does this mean for me? I have textured breast implants. Now what?

This is such an important question and I hope to reassure you with my answer. At least three women with textured breast implants in my own practice have asked me this. For reasons detailed above, I chose to use a textured device in you. Or your plastic surgeon, assuming I did not place your textured implants, chose to use a textured device in you. Chances are, your plastic surgeon made this decision based on what he or she felt was in your best interest. As physicians we take calculated risks, and this is particularly relevant in cosmetic or elective cases. Even breast reconstruction after breast cancer is, by definition, elective. So the onus on the physician to do right by his or her patient is particularly relevant to women asking this question. You may also ask whether you need specialized screening for BIA-ALCL given your stratified risk elevation as a textured device implantee. Finally if you have textured implants do they need to come out? If you are scheduled for forthcoming surgery using textured devices do you need to cancel the operation? Is it worth the risk? According to the most recent FDA recommendations, you do not need special screening and you do not acquire implant removal. The American Society for Aesthetic Plastic Surgery (ASAPS) agrees that there is not sufficient data to warrant implant removal or even to discontinue offering textured implants. However, there needs to be a meaningful conversation between you and your board certified plastic surgeon to ensure that best practices are employed, the rationale for textured device is sound, if possible that a textured device with the lowest risk for BIA-ALCL is used, and that you have adequate follow-up. This is the most important thing, follow up. It is not common to follow up routinely after a breast augmentation or reconstruction for 10 years, when the disease may surface. If you had breast augmentation with smooth or textured implants but do not have a plastic surgeon because that plastic surgeon no longer practices, or you moved, then maybe it’s time to establish a relationship with a new plastic surgeon. Even if that means we’re screening or offering routine follow-up only. It doesn’t mean that you need surgery, just that you need somebody to be there for you. Just to check in once in a while. If you are scheduled for breast surgery using textured implants with me, we have already had this conversation, and discussed why we are using a particular device. At any time prior to or even the day of surgery you are entitled to change your mind. If you are scheduled for surgery with another board certified plastic surgeon, and textured devices will be used, I hope that the topic of BIA-ALCL was brought up. Is it was not, it needs to be brought up. Even with the recent media attention, qualified board certified plastic surgeons may not be sufficiently concerned to bring this up without prompt. But it does deserve discussion. If the plastic surgeon does not initiate this discussion or downplays the risks sufficiently, that may be an indication to seek a second opinion.

Even though the incidence of BIA-ALCL seems extremely rare especially with fine textured implants and smooth implants, this is my body, and I do not want to take risks. Not even calculated risks. Are there safer alternatives?

This is a completely understandable concern and response. While smooth implants have a near-zero incidence of BIA-ALCL, they remain the most logical alternative to textured implants in all cases, reconstructive and cosmetic. But there are still women who do not want the implants at all. There are excellent alternatives to prosthetic mammary implants and they have been around for a very long time. As we evolved as a specialty, techniques, outcomes, predictability, and safety of alternatives for implant-based breast surgery are only getting better with each and every new generation of plastic surgeons. I for one feel as well-versed reconstructing a breast with your own body parts as I do using implants. in some cases I use both implants and other body parts to reconstruct a breast. Fat grafting is another technique that is wonderful in both cosmetic and reconstructive breast surgery. Although limitations do exist and secondary and tertiary procedures may be needed, there is no doubt that I have seen some amazing results when your own tissue is used to enhance or completely rebuild your breast. In the realm of breast reconstruction, I can use your shoulder muscle, your abdomen, your thigh, your buttock, or your own fat to rebuild your breast from the ground up. These are all great methods to organically rebuild you using you. In the realm of cosmetic surgery hybrid breast augmentation is gaining a lot of popularity in the US and abroad. This entails using your own fat to enhance a breast implant that was placed, or in some cases, to obviate the need for a breast implant altogether. This may require several procedures and should only be performed by a board-certified plastic surgeon who understands the nuances and the risks of fat transfer surgery. All too often, social media highlights the work of both skilled plastic surgeons and charlatans taking sizeable volumes of fat from the abdomen and arms and back and transplanting it to the buttocks. The same logic and technique can be used to enhance or reconstruct the breast. But this must be performed by a skilled plastic surgeon and you must commit to routine mammogram screening. One of the downfalls of using fat in breast cancer patients is that it can lead to mammographic abnormalities that can confuse a radiologist or oncologist, or even worse, lead to unnecessary biopsies and even surgery. There is a theoretical risk that transplanting stem cells from fat into a breast can increase the risk of converting normal cells to breast cancer cells. This is a frightening prospect, but it has not been demonstrated in the literature, and does not yet deter me from offering it and routinely using it in my practice. The most important alternative, of course is that you understand that it is not medically necessary to reconstruct a breast that has been removed for the sake of treating breast cancer. Women are entitled to breast cancer reconstruction in the United States, and legislature mandates that it is a covered service by insurance companies, but this does not imply in any way that it is medically necessary.

I have textured implants and I want them out; what are my choices?

I have been confronted by many women who are sufficiently worried by recent press releases and announcements from news outlets, and other women who for the past decade have attributed systemic illnesses an autoimmune disease to their breast implants. In the end, they want their implants out. What are the choices? First of all, if you have textured implants and you want them out, it is safe, albeit not recommended by the FDA or ASAPS, to remove them altogether. The implant can be replaced with a smooth implant without performing any resection of the capsule. alternatively the implant and it’s investing capsule can be replaced as a single unit. This is what is often called en bloc capsulectomy. The implants can either be replaced with a smooth device, fat, or nothing at all. If it’s not being replaced, often times, removal of the capsule and a breast lift will be performed at the same time to eliminate the potential for fluid collections and the appearance of a deflated or droopy breasts. This brings me to another discussion point. The concept of breast implant illness is nothing new. For years women have attributed their breast implants to autoimmune disease, lethargy, psychiatric and psychological disturbances without a clear origin. This led to a moratorium, or prohibition, of silicone breast implants for nearly a decade in the United States. Since 2006, this moratorium was overturned and we have not looked back, because there is no clear evidence that implicates breast implants with diseases such as lupus and other autoimmune phenomena. But by telling you that implants are acceptably safe for me to use them in my practice, you, your friends and the community at large are still entitled to a concern or suspicion that the implants are indeed causing medical problems. There are plastic surgeons who has become self-labeled experts of breast implant removal. Their entire medical practice has been reconfigured to remove implants in women who attribute medical problems or other fears to having breast implants. These so-called experts will often use terms like en bloc capsulectomy and even will suggest that they are uniquely qualified to perform this procedure. This is not true. Any board certified plastic surgeon is not only trained, but is qualified to remove the implant and it’s investing capsule as a single unit. This is called en bloc capsulectomy. It is easier to perform this procedure than to remove the implant and the capsule as two separate entities. In addition, a larger-than-normal incision is often used to expose and remove the implant and it’s investing capsule as a single unit. In many cases this is covered by insurance. Please do not be fooled by claims that you need to see a plastic surgeon who only performs implant removals if you want your implants removed. If you have established a meaningful relationship with such a plastic surgeon and trust them, this is completely different and you should move forward by all means. But to travel to another city or country, pay exorbitant fees, or even venture outside your insurance network is not fair to you. In my opinion, the two questions you should ask any board certified plastic surgeon to ensure they are capable is offering a service are: 1. What specialty are you board certified in? and 2. Are you comfortable performing a total, or en bloc capsulectomy? If the board certified plastic surgeon is board-certified by the American Board of Medical Specialties and the American Board of Plastic Surgery, and they say absolutely they can perform an en bloc capsulectomy, these are the only qualifications that are necessary. Please note that some plastic surgeons may choose not to remove any or all of the capsule for other reasons, such as a very thin capsule exists or there is no capsule at all, that the risks of bleeding and pain do not warrant the potential benefits of removing a thin or non-existent capsule. Alternatively, if you have a bleeding disorder then there may be unnecessary risk associated with so-called en bloc capsulectomy. I have recently become aware of this phenomenon of en bloc capsulectomy specialists, and I’m somewhat confused by it because this emerging “sub-subspecialty” seems to benefit from patients plagued by under-counseled fears and insecurities, and these doctors may be promoting unnecessary surgery that carries its own risks in women who do not require said surgery.

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