Removal of breast implants & Capsulectomy

Textured Implants

In 2011, the FDA announced a POSSIBLE association between textured implants and a rare 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 ALCL associated with only SMOOTH implants. Patients with smooth implants who developed 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 to found to have an incidence of 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 ALCL. The classic presentation of 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 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 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 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 ALCL. But for patients with a 1 in 2800, I cannot in good conscience simply tell them to watch for the signs of 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 ALCL come primarily from Dr. Mark Clemens at MD Anderson in Texas, where they have been collecting all the cases of ALCL. And the basis for the recommendations are the following: 1) ALCL is still not well understood. 2) There has been at least one case of 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 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. 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 proven. Given this FAILURE on the part of Plastic Surgery to identify-acknowledge BII over a 60-year period, Dr. Nicolaidis has made BII the focus of his practice now.

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: Conflict of interest continues to be a huge problem. Previous studies that demonstrated breast implant safety (and contributed  to their acceptance by the FDA) were all either funded by breast implant companies or performed by consultants that were paid by breast implant companies. Such data can no longer be recognized. Multiple RETROSPECTIVE studies have now shown an improvement in symptoms following explantation, such that even the plastic surgeon nonbelievers acknowledge this improvement. One of the new debates involves what type of capsulectomy is necessary in order to achieve symptom improvement. For patients who develop established autoimmune disease, symptom improvement seems to require not only capsulectomy but additional medical treatment as well.

Dr. Nicolaidis has presented the first PROSPECTIVE study of 182 consecutive explant patients (The ASPS Meeting 2020), showing that the symptoms that improve the most following explantation are 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, 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. Placebo effects can NOT explain these improvements!


Objectives

Explantation involves not only the removal of the implant but its surrounding capsule, given 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 and 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 stuck to the underlying ribs as well, requiring careful dissection without entering the lung cavity. 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 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. However, it must be understood that a capsulectomy en bloc requires an incision length longer than the diameter of the implant.

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.

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 another ongoing 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. So the results of the study are already 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. “You’re better off just following for the signs of ALCL then.”

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 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. 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. If a breast lift is desired, removal of breast implants and capsulectomy can be done at the same time but these are done in a private center in Montreal, in which case there is a minimal to no wait.

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.

Anesthesia

Dr. Nicolaidis always performs explantation under general anesthesia.


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 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 5 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 which 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 because of the danger of nipple necrosis.

Other complications are those seen with any surgeries under general anesthesia, that is infection, reaction to anesthesia, etc.