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ABOUT RANDALL FEINGOLD, MD

Dr. Feingold, a renowned expert in breast reconstruction and microsurgery, was an early leader in offering and refining natural tissue techniques including DIEP, SIEA, TUG, PAP, and GAP flaps in breast cancer and risk-reducing patients. He utilizes flap reconstruction to transform outcomes for patients suffering from unsatisfactory attempts with implants. He has 28 years’ experience with enbloc total capsulectomies for ruptured implants, capsular contracture, textured implants and symptoms of breast implant related illnesses. He is a member of the ASPS Patient Safety Subcommittee and its Breast Implant Safety workgroup investigating breast implant illnesses.

Dr. Feingold brings scientific principles and extensive experience in breast reconstruction to his management of explant patients. Consultations focus on listening to his patients’ symptoms and determining together the desired goals for surgical outcomes. He has a detailed protocol for the performance of capsulectomies and en bloc explant including:

• Total enbloc/intact capsulectomy (never partial)
• Pain management with nerve block to the rib cage
• Repair of the pectoralis muscle to restore normal function
• Placement of surgical drain tube to prevent fluid accumulation and new capsule formation 
• Breast lift/mastopexy to improve breast shape and position when desired
• Fat graft/transfers to minimize asymmetry, deformity and improve volume as needed 
• Photo documentation of capsules and implants provided to patients for reassurance
• Pathology evaluation of capsules to assess degree of inflammation and rule out malignancy (particularly for textured implants)
• Microbiology testing of capsule lining to investigate for colonies of bacteria and fungus/mold
• Long term antibiotic or antifungal therapy for positive cultures

 Great attention is paid to aesthetic outcomes. He appreciates the difficult decision women are faced with in choosing explant surgery for the purposes of health and peace of mind. This dedication has attracted women from around the country seeking his opinion and treatment. 

Randall S. Feingold, M.D. is a founding partner of NYBRA Plastic Surgery. He has been practicing on Long Island, New York since 1994. Certified by the American Board of Plastic Surgery, he specializes in aesthetic surgery of the face, breast and body as well as state-of-the-art post-mastectomy breast reconstruction. Dr. Feingold graduated Magna Cum Laude from the Albany Medical College of Union University where he was elected to the Alpha Omega Alpha honor society. He completed residencies in Surgery at NYU Medical Center/Bellevue Hospital Center, and Plastic Surgery at Montefiore Medical Center where he was awarded the Leo M. Davidoff Society Certificate of Distinction. He is a Clinical Associate Professor of Surgery in the Zucker School of Medicine at Hofstra/Northwell and a member of its Admissions Committee. He has held many leadership positions at numerous hospitals and is the Director of Plastic Surgery at St. Francis Hospital in Roslyn, NY.

EXplant surgery Explained by Randall Feingold, MD

Join our posts, news and events with Dr. Randall Feingold dedicated to answering your questions about Breast implant illness, Explant surgery, en bloc capsulectomy, ruptured silicone implants, Breast lift and fat grafting.

We created this series to help you make informed decisions.

What is Breast Implant Illness?

This is the 1st installment in my 10-part series “EXplant EXplained”. It cannot be denied that many women experience unfavorable changes in their body after breast implants. These include fatigue, brain fog, joint pain, skin rashes and hair loss amongst other symptoms. The relationship between implants and symptoms has been the subject of debate over many decades. The FDA has acknowledged not only that these symptoms occur, but that they resolve in many women after explant surgery. This is required language on implant labeling and in mandatory preoperative patient decision checklists. The cause of these symptoms is under investigation and may include autoimmune responses, bacterial and fungal contamination (biofilm) and elements from the silicone gel filler (toxins).

Improvement or resolution from symptoms of BII in many patients follow surgical management which is customized to each person’s surgical history, body type and goals. Details will follow in the next installment: The Difference between Explant and Capsulectomy

Capsulectomy vs. Explant, what is the difference?

Removing a breast implant is considered explant surgery, and it may only require a small incision, no drains, and a quick recovery.

What is a capsule?

A capsule is your body’s response to a foreign object. It essentially walls off the breast implant in a layer of fibrous tissue, isolating it from the rest of the body. Some capsules are thin, some thick. Some may contain silicone gel droplets, calcifications, particulates from the surface of textured implants, bacteria or fungal colonies. Inflammatory cells are often present and in rare cases a lymphoma may be present.

What is en bloc?

The decision to remove the capsule needs to be thoroughly reviewed with your surgeon. The procedure itself may take an hour or more per side, involves a longer incision, the placement of a temporary drain tube and a 2-week recovery period to manage the pain and minimize the risk of bleeding after surgery. “En bloc” capsulectomy is the removal of the entire capsule with the implant contained within. I do not actually see the implants until I open the capsules on the back table.

Do not confuse the term en bloc capsulectomy with en bloc resection of cancer. In that scenario, normal tissues are intentionally removed widely around a cancer to ensure its complete removal.

In en bloc capsulectomy only the capsule is removed to contain the implant, and there should be little normal breast tissue, body fat or muscle fiber on the surface of the removed capsule. Some people use the term “total” capsulectomy, but that does not clarify whether the capsule was removed in one or more pieces, so the term “total intact” capsulectomy would be a better alternative to the term en bloc capsulectomy. I photo-document my capsule specimens so that my patients can feel comfortable that they were indeed removed. I also send my capsule specimens to pathology, as well as for bacterial and fungal cultures.

Pathologic abnormalities

Pathologic abnormalities such as inflammation are common, but malignancy is very rare. On the other hand, bacterial cultures are often positive for a variety of microorganisms, and less commonly fungi. In these cases, I discuss prolonged treatment with my patients. Why do a capsulectomy? There are many situations in which a capsulectomy will appeal to my patients. These include ruptured silicone gel implants, contractures of the capsule, textured implant and systemic symptoms of breast implant illness. The rationale behind capsulectomy in these scenarios are different and I will dive deeper into each of these 4 entities in upcoming posts.

Capsulectomy for Ruptured Implants

Implants are not lifetime devices; they are machine-made and will fail at some time in your life. For those who want to maintain a breast implant you will likely need more surgeries in your lifetime depending on your age. This is similarly true for joint replacements, heart valves and pacemakers. No one knows for sure when a breast implant will leak, the FDA recommends imaging gel implants after 4 or 5 years and every few years thereafter. I have seen saline and silicone implant ruptures at 3 years and intact implants after 20 years.

How would you know if your implant has leaked?

Saline implants will flatten after just a few days as the saline is absorbed through the capsule into your body. You do not need to go to medical school to figure that one out. Silicone gel implants may leak with no symptoms (silent rupture), or with pain, or with tightening (contracture) of the capsule causing deformity and elevation of the implant on the chest wall. If the silicone gel is contained within the capsule, it is called an intracapsular rupture. But if the silicone travels through the capsule and has moved into the breast tissues it is called an extracapsular rupture. Ultrasound and non-contrast MRI can verify implant integrity and determine the spread of silicone gel. I have seen extracapsular silicone reach into the axillary (armpit) lymph nodes which I can sometimes retrieve at surgery. I have even seen extracapsular silicone travel into the neck (supraclavicular and cervical) lymph nodes which I cannot retrieve at surgery.

Removing a ruptured breast implant alone will still leave behind the scar capsule that has been exposed to and coated with the contents of the leaked implant. Removing the free silicone gel (without the capsule to contain it) is a messy operation, smearing the gel on the surgical instruments and gloves as well as your skin in the process. It is virtually impossible to get all the gel out even with extensive irrigation. The advantages of performing an en bloc/total capsulectomy in the case of ruptured implants is that it allows removal of all the implant remnants and leaked gel without spillage of contents, and removal of the coated capsule tissues as well. It is very gratifying at surgery to remove the intact capsule and then open it on the back table to reveal the disintegrated implant shell and free silicone gel knowing that it was a clean removal. And occasionally I will open the capsule and discover that an implant has ruptured when it was not suspected to be that way prior to surgery, another bonus for routinely performing total capsulectomies. The breast is then irrigated with antibiotics, and a drain tube left in place for a few days. This does not preclude breast lift or fat grafting at the same time.

One more thing, I consider removal of ruptured implants a medical necessity and so do many insurance carriers (if the implants were silicone gel), so insurance coverage for capsulectomies may be possible in certain cases.

Abnormalities

Women who undergo explant surgery are faced with having to make overwhelming decisions before and after this procedure. Awareness and exposure to dedicated social media groups often helps to understand what needs to be done in order to avoid unnecessary health complications in the future. One specific topic is related to screening for abnormalities in the capsule.

Women are mostly concerned with their safety. They need to know that their doctor not only removed the implants and the capsules entirely,  but also ran all the necessary tests to rule out pathological findings. 

Questions such as what are the standardized exams,  and did their specific doctor provide them with all the necessary ones. Many shared posts on social media validate that at the present time not all plastic surgeons include pathology evaluation of the removed capsules.

College of American Pathologists requirements

One of the reasons is that The last revised recommendations by the College of American Pathologists, which include breast implants, have no requirements for microscopic analysis of implant capsules.

Furthermore, the recommendations for processing specimens by pathologists are not defined and appear to vary according to particular institutional bylaws. 

Recommendations in textbooks are still for random sampling, 

No standardized pathologic processing of the capsules exists

Further sampling or analysis may be triggered by pathologists when neoplastic or atypical cells are unexpectedly found upon microscopic examination. This would include immunohistochemically stains such as CD30 and ALK. But no standardized exams of the capsules associated with breast implants illness are in place.

Breast implant capsules abnormalities

In reality Breast Implant Associated- Anaplastic Large Cell Lymphoma occurs rarely while inflammation, fungus and bacteria in the capsules are common. According to Dr. Feingold 30-40% of the capsules return positive with some kind of pathogens, for which he recommends further treatment. 

Mold or Fungus

Randall Feingold, MD performs en bloc explant surgery regularly and has developed a safety protocol based on his clinical training and many years of experience that provides a panel of pathology evaluation of the capsules to rule out certain abnormalities. 

Taking Bacterial cultures

He photo-documents the capsule specimens so that his patients can feel comfortable that they were indeed removed. He also sends the capsules specimens to pathology, as well as for bacterial and fungal cultures. These tests are done during the explant surgery and typically the results are ready within 7-28 days. 

Randall Feingold, MD uses the following protocol to thoroughly evaluate and treat his patients

Randal Feingold’s list

• Photo documentation of capsules and implants provided to patients for reassurance
• Pathology evaluation of capsules to assess degree of inflammation and rule out malignancy (particularly for textured implants)
• Microbiology testing of capsule lining to investigate for colonies of bacteria and fungus/mold
• Long term antibiotic or antifungal therapy for positive cultures

Final Note

To summarize, different pathology labs may study capsule specimens differently. Discuss this with your plastic surgeon before surgery to ensure that useful studies such as pathology and microbiology are performed to increase the likelihood of finding the underlying cause of symptoms and allow selection of proper treatments.