Removal of breast implants & Capsulectomy
In 2011, the FDA announced a POSSIBLE association between textured implants and a lymphoma called Anaplastic Large Cell Lymphoma (ALCL). By 2016, a DEFINITE association was established and became widely known. There has never been a reported case of Breast Implant Associated (BIA)-ALCL associated with only SMOOTH implants. Patients with smooth implants who developed BIA-ALCL were all found to have been exposed to textured implants at some point in their lives. Originally, the incidence of the lymphoma was estimated to be only one in 1 million (1:1,000,000). Nevertheless, Dr. Nicolaidis stopped using these types of implants, feeling that any risk of cancer was unacceptable. Unfortunately, the incidence has since been found to be 1:36,000 with micro-textured implants such as those of Mentor. Moreover, the macro-textured implants from Allergan (Biocell) have since been found to have an incidence of BIA-ALCL as high as 1 in 1000 to 1 in 2800, prompting the voluntary recall of Biocell implants from the market in July 2019.
The normal reaction of the human body to any foreign object (Including breast implants) is to form a capsule around that object. That is completely normal for the human body. With textured implants, the rough surface between the implant and the capsule is thought to create a chronic and constant inflammatory response, which may ultimately lead to BIA-ALCL. The classic presentation of BIA-ALCL is the development of fluid around the implant–capsule, formation of a mass, deep itching over the implant or swelling of adjacent lymph nodes, typically about 7-8 years after breast augmentation. Unfortunately, a small percentage of patients with BIA-ALCL will not develop any of these signs, leading to dalayed diagnosis and treatment. Current guidelines recommend biopsy of the mass or collection of the fluid to rule out BIA-ALCL, using the CD 30 marker. The treatment for DIAGNOSED-CONFIRMED BIA-ALCL is capsulectomy-en-bloc, an oncologic term which implies the removal of the implant, its capsule as well as a cuff of normal surrunding tissue. But the current American-Canadian recommendation for patients with textured implants BUT NO DIAGNOSIS OF BIA-ALCL is to simply follow these patients and biopsy if a collection or mass develops. Understandably, patients with textured Allergan implants find that recommendation difficult to accept. These patients are often heard saying “I feel like I have a bomb in my chest, waiting to explode”.
Dr. Nicolaidis: “It’s one thing to follow patients with a 1 in 36,000 risk of lymphoma for the signs of BIA-ALCL. But for patients with a 1 in 1000-2800 risk, I cannot in good conscience simply tell them to watch for the signs of BIA-ALCL… because that’s NOT what I would do if my wife had Biocell implants! In difficult situations such as this, doctors should not play God and simply tell patients what to do. Rather, patients must be told and understand the FACTS in order to make an informed decision themselves.
So here are the facts. These recommendations to follow patients with textured implants for the signs of BIA-ALCL come primarily from MD Anderson in Texas, where they have been collecting all the cases of BIA-ALCL. And the basis for the recommendations are the following: 1) BIA-ALCL is still not well understood. 2) There has been at least one case of BIA-ALCL developing in a patient who supposedly had a prophylactic capsulectomy. The problem is that it is not certain that the capsule was completely removed. 3) Acceleration of BIA-ALCL has been seen following capsular biopsy. 4) Risks of capsulectomy are significant. Sorry but Plastic Surgeons experienced in explant surgery do NOT find the risks to be significant (discussed later). Once again, patients must be told and understand the risks of capsulectomy in order to make an informed decision themselves.
Breast Implant Illness
HISTORY: Silicone breast implants were introduced in 1963. Within a year, there were already complaints of various symptoms from implanted patients. Unfortunately, these complaints were not taken seriously by neither their Plastic Surgeons nor the implant companies, who both argued that breast implants were perfectly harmless. Moreover, many studies showed that breast implants were completely safe, despite a similar number of studies confirming higher incidence of scleroderma or rheumatic disorders among patients with breast implants. The problem is that these studies that demonstrated breast implant safety (and contributed to their acceptance by the FDA) were usually either funded by breast implant companies or performed by consultants that were paid by breast implant companies. It’s not very difficult to understand that a Plastic Surgeon who is paid by a breast implant company or makes a lot of money with breast implants (you get the idea) cannot be relied upon to study breast implant safety in a neutral fashion. We call that CONFLICT OF INTEREST. Although such studies were accepted in the past, studies with such conflict of interest are no longer considered valid in the scientific communities. With the recognition of BIA-ALCL secondary to textured breast implants, it became apparent to everyone that breast implants were not so harmless after all. With social media, these many thousands of patients rallied together to make their voices heard. Finally, Breast Implant Illness (BII) has become acknowleged by the national health organizations and Plastic Surgery associations throughout the world, although it is yet to be understood.
Given the FAILURE on the part of Plastic Surgery and breast implant companies to identify-acknowledge BII over a 60-year period, Dr. Nicolaidis has made BII the focus of his practice now. With all the MISINFORMATION to be found on the internet, he has made an extra effort to make this section as comprehensive AND FACTUAL as possible.
INCIDENCE: BII is estimated to develop in between one and 10% of implanted patients.
ETIOLOGY: Although the etiology of BII is unclear, it is felt to be the result of chronic reaction and inflammation to either silicone or other chemicals in the processing of breast implants.
SYMPTOMS: Symptoms are varied and span from head to toe: hair loss, skin rashes, brain fog, headaches, difficulty concentrating, dry eyes, dry mucosa, difficulty breathing, irritable bowel, muscle pain, bone pain, joint pain. Severe cases can progress to autoimmune diseases. BII sceptics will often argue that many of these symptoms are the same symptoms one might see with menopause or that the symptoms can be just about anything. But a Plastic Surgeon who truly listens to these patients will see consistencies in the symptoms.
IMPORTANT: Given all of the discussion around BII on the Internet now, many implanted patients are consulting Dr. Nicolaidis with the concern and even anxiety that they might have BII. Do not forget that 90-99% of implanted patients do not develop BII. Breast, neck, back and shoulder pain are mechanical problems due to the additional weight over the chest, not BII. Also, breast implants cannot be blamed for every problem a patient has. The symptoms with BII are fairly consistent. Dr. Nicolaidis will assess at the time of consultation.
RISK FACTORS: Patients at higher risk of developing BII with breast implants are THOUGHT to be those with allergy history, skin disorders, thyroid disease, asthma, food intolerance, history of autoimmune disease. But this remains speculation for now.
PROOF OF BII: To the disappointment of both Dr. Nicolaidis and the BII community, CONFLICT OF INTEREST continues to be a problem with respect to breast implant safety. Despite that, multiple RETROSPECTIVE studies have now shown an improvement in symptoms following explantation, such that even the Plastic Surgeon nonbelievers acknowledge this improvement. Nevertheless, the sceptics argue that this symptom improvement after explantation is simply placebo effect. One of the new debates for Plastic Surgeons in general (NOT for Dr. Nicolaidis) involves what type of capsulectomy is necessary in order to achieve symptom improvement.
Dr. Nicolaidis presented the first PROSPECTIVE study of 182 consecutive explant patients at the Breast Implant Health Summit in October 2020. Symptoms that improved the most following explantation were respiratory problems (89% improvement), fatigue (74%), muscle pain and weakness (70%) and brain fog (66%). For the sceptics who might argue that this is all placebo effect, Dr. Nicolaidis found that two patients stopped their bronchodilators altogether after explantation, three stopped Synthroid, two decreased their Synthroid dose, two decreased their doses of gastrointestinal medications, one stopped their blood pressure medication, 6 stopped pain medications and 12 others either reduced or stopped other medications. Sorry but placebo effects can NOT explain these improvements!
For patients who develop established autoimmune disease with breast implants, symptom improvement seems to require not only capsulectomy but additional medical treatment as well (discussed later).
Explantation involves not only the removal of the implant but its surrounding capsule, the thinking being that the capsule contains the inflammatory response to the breast implant. Capsulectomies are done through a long incision in the fold under the breast in order to allow for adequate exposure of the implant and its capsule. The surgery can be exceedingly difficult because the capsule is typically adherent to the surrounding muscles, leading to a small degree of damage to the surrounding muscle during explantation and sometimes requiring a few simple stitches to repair. In the case of implants under the muscle, surgery is that much more difficult because the capsule is often stuck to the underlying ribs as well, requiring careful dissection without entering the space around the lungs (PNEUMOTHORAX). It is important to clarify that although many patients feel much better right after their explantation, there is NO GUARANTEE that the BII symptoms will improve after explanation.
Different Types of Capsulectomy
CAPSULECTOMY-EN-BLOC: Capsulectomy en bloc is an oncologic term recommended for diagnosed BIA-ALCL, involving the removal of the implant and its entire capsule as one unit, with a cuff of surrounding normal tissue. There is no debate over this treatment. However, patients with BII have been requesting capsulectomy en bloc to treat their symptoms. Obviously, these patients do not desire removal of surrounding normal tissue, given that they do not have cancer. Rather, they want the implant and capsule to be removed together as one unit. Given that BII is not understood, Dr. Nicolaidis feels that such a capsulectomy is not unreasonable in order to remove any possible silicone, infection, liquid, etc that may exist within the capsule, particularly in the case of ruptured silicone implants. How about we call it a “single specimen capsulectomy”? However, it must be understood that such a capsulectomy requires an incision length longer than the diameter of the implant. It doesn’t take a rocket scientist to understand that a breast implant with an average diameter of 11 cm cannot be removed through a 5 cm (2 inch) incision.
COMPLETE CAPSULECTOMY: Although Dr. Nicolaidis sees a certain logic in removing implants and capsule as a single unit, patients must understand that it cannot always be done, particularly in the case of thin capsules (which tear easily during dissection) or large implants (unless patients accept an even longer incision in the breast fold). In such cases, the implant is removed from the capsule in order to permit better visualization and removal of the capsule. Given our limited understanding of BII, Dr. Nicolaidis and most explant surgeons feel that removal of the entire capsule is necessary. No capsule is left behind.
EXPLORATORY CAPSULECTOMY: Many patients have reached out to Dr. Nicolaidis with the concern that capsule was left behind after their removal of implants. The removal of implants is very likely more important than that of the capsule. The important issue is symptom improvement in the patient. If the patient has complete resolution of symptoms, then further treatment may not be necessary. However, several patients have presented with persistence of symptoms after either simple removal of implants or incomplete capsulectomy. In these cases, Dr. Nicolaidis explored the submuscular or subglandular pockets and removed residual capsule, and was very pleased to see symptom improvement in the patient. However, this is not proven, nor can Dr. Nicolaidis guarantee improvement of symptoms following exploratory capsulectomy.
PARTIAL CAPSULECTOMY: In an effort to minimize the risk of pneumothorax (discussed later), some Plastic Surgeons with less experience in explant surgery have proposed leaving behind the posterior wall of the capsule, which is often very adherent to the rib cage. The only unbiased study that has looked at the effect of different degrees of capsulectomy on BII symptom improvement is that of Diana Zuckerman, who found that BII symptom relief was best following COMPLETE capsulectomy. As of April 2021, there is an ongoing well-funded study looking at the effects of different degrees of capsulectomy on BII symptoms. Unfortunately, one of the lead researchers in particular is riddled with conflict of interest regarding breast implant safety. Consequently, the findings of the study are understandably being questioned by the BII community before they even come out. Given Zuckerman’s findings and Dr. Nicolaidis’ experience that the risks of pneumothorax are minimal, he NEVER recommends partial capsulectomy. Moreover, he cautions patients with textured Allergan implants to never ever accept only partial capsulectomy as a prophylactic measure, given what has been observed to date. “You’re better off just following for the signs of ALCL then.”
DRAINAGE > CAPSULECTOMY: A fourth approach has been circulating in early 2021, specific to saline implants. Some Plastic Surgeons have been emptying saline implants and then performing capsulectomy. The advantage to allow a smaller skin incision for capsulectomy; however, the concern of patients is the inevitable spillage of saline (with whatever other chemicals may be present within the implant shell). Once again, given our limited understanding of BII, Dr. Nicolaidis feels that it is more prudent to remove everything as a single specimen without drainage. But that is his opinion.
Dr. Nicolaidis: “BII is far from understood. So I approach it very cautiously. There are some issues that are very clear while others that are completely uncertain. Also, different patients have different priorities with respect to their health, scars, etc. In such cases of uncertainty, patients should be listened to and understand the risks and benefits of the various options so that they can make an informed decision.”
Removal of Breast Implants Cost : Procedure sometimes paid by the government (RAMQ)
Removal of breast implants and capsulectomy are covered by the government in three circumstances: 1) Polyurethane implants 2) Documented ruptured gel implants 3) Documented grade 4 contracture (in which the capsule becomes hard and painful).
Given the one in 2800 (1:2800) risk of BIA-ALCL with textured Allergan implants, Dr. Nicolaidis asked that the Plastic Surgery Association of Quebec push for textured Allergan implants to be a fourth indication that would be covered by the RAMQ in 2019. He has not yet received a response.
Authorization for capsulectomy requires radiologic proof of one of the above before surgery, the operative protocol and a pathology report confirming the above, all to be submitted after the pathology report is received however many months after surgery. If anything is missing or cannot be found, the surgery is not reimbursed. Such has been the case for at least 5 surgeries performed by Dr. Nicolaidis, a situation made even more frustrating by the fact that the RAMQ can no longer be reached during the Covid period.
Also, Dr. Nicolaidis works at the CHUM super hospital, where his directive is to deal with skin cancers and their reconstruction. He does not have operating time to perform explantations.
For all of these reasons, Dr. Nicolaidis does not perform explantations under the RAMQ at the hospital. Rather, he performs explantations at a private surgery center.
If you’ve had a breast explant, regardless of when, we invite you to complete a post-explant questionnaire to tell us about your experience. By doing this, you will help us to better understand the possible impact of implants and explants on health.
Removal of implants with breast lift
After breast implants are removed, the skin envelope of the breast becomes too large for the quantity of tissue within, causing the breasts to hang and lose their shape, often leading to ugly folds. And when folds form after explantation, they can be very difficult (sometimes impossible) to correct. Removal of excess skin is required to improve the breast shape (called a breast lift). While the removal of prostheses and capsulectomy are sometimes covered, the RAMQ NEVER covers breast lifts.
It is important that patients have realistic expectations after explantation. The priority is to remove the implant with its entire capsule. The bigger the implant and the thinner the patient’s skin and tissues, the more the skin will tend to fold after explantation. Breast lifts after explantation are designed to minimize the folding and give a reasonable shape to the breasts. Dr. Nicolaidis is NOT a magician. Patients with minimal tissue before breast augmentation will finish with minimal tissue after explantation. Nevertheless, Dr. Nicolaidis regularly hears from his patients that they find their breasts nicer after explantation than they were before augmentation. And rest assured, there are other options that can be offered later on if patients are not satisfied with their breasts, the main option being transfer of fat to the breasts. Dr. Nicolaidis NEVER transfers fat at the time of explant because of the significant risk of infection. Rather, he performs fat transfer as a secondary procedure (usually 4 to 6 months later) in order to retouch irregularities that often develop after explantation. Like all interventions, fat transfer is not without risks. Dr. Nicolaidis will discuss these risks at the time of consultation.
Dr. Nicolaidis was the first Plastic Surgeon to report on the appearance of the breasts following explantation in a prospective study of his first 182 explant cases for Breast Implant Illness (The ASPS Meeting 2020). 52% of patients were very satisfied with the appearance of their breasts, 33% were satisfied and 15% were not satisfied. However, NO patients regretted having the surgery, given their symptom improvement.
Dr. Nicolaidis always performs explantation under general anesthesia with board-certified anesthetists.
Recovery after explantation
Dr. Nicolaidis asks patients to keep their elbows stuck to their sides for the first 2 weeks after surgery, in an effort to decrease the risk of bleeding. Following explantation, dressings are left in place for 1 week. Drains are rarely used, when Dr. Nicolaidis is concerned about bleeding or collections. Patients are asked to keep the dressing dry and clean. Wounds are usually well healed by two to three weeks after surgery. Patients are asked to sleep only on their back and not to force with their arms for a period of one month.
Return to work after explantation
Time off work depends on the patient’s type of work. As already stated, patients cannot force with their arms for a period of one month. A conservative period of time off work is between two and four weeks.
Complications specific to Capsulectomy with removal of breast implants
Dr. Nicolaidis was the first Plastic Surgeon to report on the complications of capsulectomy in a prospective study of his first 182 explant cases for Breast Implant Illness (The ASPS Meeting 2020). As of April 2021, he has doubled that number of cases. And here are the complication rates.
Pneumothorax: Risk of pneumothorax is probably the main reason that many Plastic surgeons hesitate to perform complete capsulectomies. Pneumothorax involves penetration of the covering around the lung (NOT the lung itself), typically as the capsule is being peeled off of the rib cage. This occurred in 5 out of 364 patients (1.4%), all of whom had submuscular implants. The pneumothorax was recognized immediately, a small tube was placed and the hole repaired. The tube was removed the following day with no consequences.
Bleeding: Bleeding is the most common complication of capsulectomies, requiring return to the operating room to stop bleeding in 4 patients and simple drainage in clinic in 4 cases. So a total of 8 cases in 364 explantations for a rate of 2.2%.
Skin laceration: This occurred in the two out of 364 patients, both of whom had implants above the muscle. One patient had severe contracture with the capsule stuck on the skin. The other patient was extremely muscular.
Nipple necrosis: Nipple necrosis involves death of the nipple tissue when the blood supply to the nipple is severely compromised and requires removal of the nipple with later reconstruction. Dr. Nicolaidis had no cases whatsoever of nipple necrosis, despite doing lifts on most of his patients, some of which had already had previous lifts (which increases the risks to the nipples). It is important to note that many Plastic Surgeons will hesitate to do lifts at the time of explantation for fear of nipple necrosis. And they are right to hesitate. It took Dr. Nicolaidis over a year before he was comfortable enough to do a complete lift at the time of explantation without risking nipple necrosis. He now does them more and more, provided that the patient has adequate tissue.
Other complications are those seen with any surgeries under general anesthesia, that is infection, reaction to anesthesia, etc.
Revision Surgeries Following Explantations
Revision surgeries are typically done 4 to 6 months following explantation, in an effort to improve the final appearance of the breasts. But before we get to that stage, consideration is always given to massage and cupping of the skin to improve indentation, etc. Even Dr. Nicolaidis is sometimes amazed at how much breast appearance can improve with such treatments. Should that fail, minor scar revisions and releases can be done under local anesthesia. But clearly the most powerful revision tool is fat transfer to the breast.
FAT TRANSFER TO THE BREASTS: Dr. Nicolaidis was fortunate enough to hear the first presentation on fat transfer by Sidney Coleman when he was still working in New York. Fat is removed from the patient using liposuction, then concentrated and re-introduced in any area of the body desired. In order for the fat to survive, it has to be injected in small quantities and fine lines, surrounded by the patient’s tissues which will vascularize the fat. If larger quantities are injected in an area so that the fat is not in direct contact with the patients tissues, that fat will die and may become infected. In such a case, cysts may form which can be misinterpreted on mammograms as possible breast cancer. A work up then becomes necessary to eliminate possible breast cancer, yet another unpleasant experience for patients who’ve already been through a lot of suffering.
Patients who benefit the most from fat transfer to the breasts are those had no or minimal breast tissue to begin with. Now try to imagine transferring fat in that patient’s very limited breast tissue right after explantation, when there is a great big empty pocket under the muscle (even worse if the pocket is above the muscle). If the fat enters that empty pocket, the fat will completely die and usually lead to an infection as well. For these reasons, Dr. Nicolaidis NEVER performs fat transfer to the breast at the time of explantation. His focus initially is to minimize the folds using various breast lift techniques, which he will discuss with patients at the time of consult. Fat transfer is then used as a secondary procedure 4-6 months later in order to fill in the necessary areas and improve the appearance of the breast.
As stated earlier, for patients who develop established autoimmune disease with breast implants or more severe symptoms, symptom improvement seems to require not only capsulectomy but additional medical treatment as well.
Dr. Tania Dempsey (New York): “BII is a complex, multisystem disease process that is first addressed with a capsulectomy but may require a more comprehensive look at the immune system, asking the question “why is the illness persistent despite surgery”. In my experience, many patients have underlying immune dysfunction that the implant triggers or exacerbates. The immune system may be dysfunctional from a variety of factors, such as Mast Cell Activation Syndrome (MCAS) and/or triggers, such as chronic infection, mold/mycotoxin illness, abnormal gut microbiome, hormone disruption, and stress, to name a few. The medical workup requires a look at these factors (and others) and how they interact with the immune system. I feel strongly about getting as much data as possible to confirm or rule out diagnoses being considered. Data allows the treatment to be more targeted and personalized for the patient. Every patient is different and some patients will need mast cell targeted therapy to get better, but others might need detox and/or dietary changes and/or gut healing and/or antibiotics and/or herbs, and/or other treatment. Removing the triggers and starting the work on treating the underlying issues is the first step to getting better. “
Danielle Valoras (PA-C, Charlotte): “Detox is not proven for the treatment of BII. But healthy eating, hydration and exercise will always improve recovery from any illness. For biotoxin illness such as Bii, the root cause may be the implants and as such explanting is a key step in the healing journey. Many people ask me about what the right ‘detox’ program to do after explant; please keep in mind that ‘detox diets’ rarely identify the specific toxins they are claimed to remove.
There is a lot of foundational work that everyone can do. Like eating clean, making sure you chew your food fully before swallowing, etc. Foundationally you can start a good nutrient rich diet, adding lots of colorful vegetables and fruits – there are many diets out there to choose from. What works for me is to keep it simple and clean. Adding in healthy foods and removing foods that can cause inflammation or cannot be digested well.
Consider a diet that encompasses clean eating: no gluten, no dairy, no processed sugar, and no alcohol with non-GMO, organic and wild caught protein sources. Make sure you are hydrated including electrolytes during the day and make sure you eat a variety of antioxidant rich foods and food that have phyto-nutrients and sulfur sources like cruciferous vegetables. Consider a diet rich in pre and pro biotics to keep your digestive system healthy, which is important for proper detoxification and immune health. Restorative sleep and stress management are extremely important; to rest is to heal. Go for balance, not perfection. Continually assess and keep up efforts to support healthy immune system balance and function.”
Danielle Valoras (PA-C, Charlotte): “The lymphatic system is a network of tissues and organs that transport lymph throughout the body. Its responsibilities include cleaning the cellular environment, returning proteins and excess tissue fluids to the blood, providing a pathway for the absorption of fats into the bloodstream, and the production and transportation of antibodies (white blood cells called lymphocytes) throughout the body to fight infection.
The lymphatic system is THOUGHT to have an important role in those who have breast implants and breast implant related illness. In short, when the lymphatic system is blocked by structure or by physiology, health can deteriorate. Picture an engine with car oil and you can equate our lymphatic system to an oil filter. Imagine how sluggish and constrictive the engine would be if the oil were not constantly filtered. Sluggish lymph fluid is a breeding ground for infection and dysregulation.
Because lymph cleanses nearly every cell in the body, symptoms of chronic lymph blockage are diverse. These symptoms can make it challenging to identify the root cause, triggers and mediators that effect our health. There are signs and symptoms you can tell if your lymphatic system is impacted. There is also thermography that can show you where your body is being the most impacted by lymph stagnation. More clinical studies are needed to identify key treatments for Breast Implant Illness. We do know that removal of the implants helps many gain vitality and health.
Treatments that MAY help support your lymphatic system include: 1. Lymphatic drainage massage and/or visceral manipulation 2. Clean healthy diet 3. Deep breathing exercises 4. Simple body movements i.e. yoga, walking, rebounding 5. Tapping on key lymphatic points (collar bone, etc.) and dry brushing 6. Infra-red sauna (post-explant) 7. Supporting adrenals with electrolytes and hydration”