Thursday, August 8, 2019

FROM CANCER LINK SUSPICION TO GLOBAL RECALL: BREAST IMPLANT ALCL REVIEW - THEN AND NOW


Introduction
The FDA (US Food & Drug Administration) first identified a possible association between certain breast implants and the development of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in 2011 [1]. On July 24, 2019,  ALCL advocacy groups and the global community of implant users finally achieved the long awaited recognition about this emergent disorder when the FDA announced Allergan's voluntary recall of their textured implants.  Such a recall raises a level of urgency about the public health risks behind BIA-ALCL with the hopes that other manufacturers would soon follow this lead.  "Whenever a company accepts responsibility to pull a risky product from the market, they usually aim to correct product flaws to eliminate public health risks. Recalls also set a great precedence for new research that can add to our scientific understanding about preventing the disorder and other paradigms like it", states implantscan.org.

Note that ALCL is not breast cancer - it is a type of non-Hodgkin’s lymphoma (cancer of the immune system) that in most cases is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body [1].  A significant number of cases are recorded to appear within 8-10 years after implantation but new reports are showing symptoms earlier.  A recent report from the American Society for Aesthetic Plastic Surgery states that the first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average of about 8 years after implantation.  A theory that the increased surface area of textured implants allows a higher number of bacteria around the implant, which forms a biofilm in some patients, and can result in chronic inflammation, ultimately leading to a proliferation of lymphocytes. [2]

A SURGEON'S REVIEW
Feat. Dr. Patricia Clark
PinkSmart News conducted an interview by late 2018 with Dr. Patricia Clark of Ironwood Women's Centers and the Ironwood Cancer and Research Centers in Scottsdale, AZ.  She provided great insight on various breast-related cancer topics, and she also helped clarify many areas of the BIA-ALCL associated Lymphoma crisis.  Dr Clark is a respected nationally recognized onco-plastic (reconstructive) surgeon. These surgeries plastic surgery techniques like breast lifts or breast reductions with cancer surgeries to conserve the breast and reconstruct the defects without implants.  Hence, if she performs a lumpectomy for breast cancer, rather than leave a lumpectomy defect or a deformity in the breast, she can modify techniques used during cosmetic breast lifts and reductions to fill the hole, repair the defect and prevent deformity. She might even operate on the other side so that the two match. She teams with leading board certified plastic surgeons to ensure patients have access to the full range of both mastectomy and partial mastectomy reconstructive options. 

Dr. Clark and others speculate the true number is of BIA-ALCL cases is likely under-reported to the FDA registry. Incidence estimates range from 1:3817 patients to 1:30,000. The treatment of BIA-ALCL that has not spread beyond the capsule of the implant is simply to remove the capsule and replace the implant. Because it forms in a different manner than other primary non-Hodgkin lymphomas that arise in lymph nodes, chemotherapy and radiation therapy are rarely necessary unless diagnosis is delayed and the disease has spread beyond the capsule. There are likely patients with implant problems who have had the implant and capsule removed, and for which a thorough pathologic examination may not have been done, but for whom the patient’s surgery was curative. Because of increased awareness, this is less likely to happen now than in early years.  A quick raise of hands to see who had treated a case by the hundreds of reconstructive plastic surgeons attending the 2018 BC3 meeting sponsored by Georgetown University resulted in more than 20 surgeons who had personally seen or worked with ALCL cases. At that time, records showed less than 500 cases being reported internationally with 16 deaths from over 30,000,000 implant placements. 



A capsule is tissue laid down around the implant that is part of the body's normal process of walling off any foreign body.  In addition, the formation or buildup of seroma fluid doesn't mean a patient is going to get cancer. That clear fluid that appears during injury or infection, or in the case if implants, is the body’s reaction to a foreign matter and to large, raw, cut areas of tissue.  Hence, every single breast implant, whether it's smooth or textured, forms this capsule. When capsule become too thick, contract, develop persistent seromas, or start to deform the implants, plastic surgeons remove and replace the implants and perform a capsulectomy- the surgical removal of scar tissue and capsule.  In doing so, this complete removal procedure inadvertently treats the disease successfully since the lymphoma is usually confined to just the capsule.

THE TEXTURED IMPLANT DILLEMMA
Manufacturers developed textured implants as an upgrade to the smoother counterpart.  Smooth implants would result in the shrinking of collagen and the fibers, leading to shrinkage and eventually causing the implants to become hard as a rock and painful. Textured implants were designed to prevent this while accommodating many shaped implants from rotating or shifting over time. Some shapes are thicker on the bottom, thinner on the top, and more teardrop-shaped like a breast. With textured implants, one Because of the texture, a leading theory of cause of BIA- ALCL is the high amount of surface area with more little nooks and crannies can trap more bacteria, which causes more immune cells to move in (lymphocytes) which are subjected to prolonged inflammation and can become cancerous. Other theories include allergic reactions associated with textured implants, and genetic factors.

BIA-ALCL may occur in all implants, smooth as well as textured, but most are associated with Allergan Biocell textured implants. These have now been recalled from the market. Since the risk of development of BIA-ALCL is so low, the FDA does not recommend removal of these implants if there is no swelling or pain. If a patient develops a seroma or fluid around the implant, this should be sampled and sent for pathology evaluation.

A current update of an estimated 1 in 30,000 textured implant risk has been reported and 573 unique and pathologically confirmed BIA-ALCL cases worldwide related to breast implants [3]- according to Dr. Clemens at the July 2019 review with the American Society of Plastic Surgeons.  But prior to this year’s recall, the use of textured implants remained prevalent and the risk figures showed an inconclusively low number and did not warrant any public safety action or manufacturer’s recall. 

“BIA-ALCL is not the same disease as the lymphomas that you see spontaneously arise in lymph nodes in the general public. It's not a disease that you treat with chemotherapy or radiation. This is somewhat limited to the implant capsule in most cases. Proportionately speaking, it is very rare … it can invade the local tissues you can have wide-spread disseminated disease or, but that's stunningly rare.”

Dr. Clark’s most recent experience with an ALCL case emphasizes the multidisciplinary care patients receive. This included radiology, pathology, medical and radiation oncology and plastic surgery. Capsules must be completely removed and are often densely adherent to the chest wall and even the periosteum (lining) of the bone of the rib. This increases complexity and difficulty in removing every single piece of it.  She recently collaborated with Scottsdale plastic surgeon Dr. Joe Berardi due to his previous experience with BIA-ALCL and meticulous approach to capsulectomies.

In summary, it is believed that the two strongest factors that provoke breast implant related lymphomas included formation of a BIOFILM; an infectious coating of bacteria embedding themselves in the surface of the implant. This biofilm recruits the immune cells, which develop the cancer.  Also, research have found immune-mediated or allergy-like eosinophils, indicating there could be an allergic component to development of ALCL.   

Biofilms are not penetrated by antibiotics and are poorly penetrated by immune cells which can result in chronic, sub-clinical infection that the body and antibiotics can’t clear.  The capsule is a physical barrier between the implant and the normal breast tissue within which it has been inserted.



THE RECALL: LANDMARKING A GAME-CHANGER
Each time a product is recalled, it reflects upon the manufacturer’s aim to rectify a known issue that could cause eventual harm to the consumer. The community of implant users and medical professionals have viewed enough cases (and fatalities) of BIA-ALCL historically that the July 24 recall marks a significant touchdown toward the industry’s recognition and global restitution of the possible disaster that this product has yet to face. “It validates the seriousness of the situation, because the layperson can understand that a company doesn't do that… (unless) there's a serious problem”, says Jennifer Cook of BIAALCL.com.

“I’m grateful for the chance that future women will develop this lymphoma has been greatly reduced. Its not only Allergan implants that create the risk, but it does appear from current data that their implants create the highest risk, and so with those implants being removed from the market, its going to greatly reduce the number of new cases of this disease being created. There's obviously a lot more work to be done but it is the first step, and an additional part of that equation for me was just awareness because all the women out there with this lymphoma, or the implants that can create it, still in their bodies right now, may have no idea about this lymphoma because no one is obligated to warn them. So any immediate attention potentially can reach them and so the withdrawal created more media attention and then hopefully, more awareness.”


BREAKING NEWS!
By: Jennifer Cook (BIAALCL.com)

August 8, 2019 – A new article has been published out of MD ANDERSON in a Modern Pathology Journal addressing the proper way to evaluate and sample an implant capsule that has been removed from a patient suspected of Breast Implant Associated ALCL.  The article indicates that the disease can often be missed if proper and thorough evaluation of the capsule is not done.  Not only can the disease be missed but often positive margins of lymphoma on the implant capsule can be missed and this can create a risk of incomplete resection of the disease w/c increases the risk of recurrence and worsens the patient's prognosis.  Therefore, a person who is suspected of having BIA-ALCL should have their surgeon and pathologist become aware of these latest new recommendations on proper pathology protocols so they can benefit from the state of the art information on how to diagnose and treat this disease.  (See complete report: https://www.nature.com/articles/s41379-019-0337-2)

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CONTRIBUTORS / TECHNICAL ADVISORS
Patricia Clark, MD, FACS is a board-certified general surgeon with a passion for treating breast cancer and for using oncoplastic surgery to improve outcomes. Additional plastic surgery training led her to become nationally recognized as a teacher of oncoplastic surgery at national and international conferences. These techniques reduce the need for mastectomy in patients with complex breast disease and they minimize deformity. She is an active member of the American Society of Breast Surgeons, the Society of Surgical Oncology, the American College of Surgeons, the National Consortium of Breast Centers and the American Society of Breast Disease. She currently practices at the Ironwood Women's Centers in Avondale AZ. (www.ironwoodwomenscenters.com)

Jennifer Cook was diagnosed with Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in August of 2017- which started her on a road to major research to collect all information about the disorder as well as seek out an international social media group of fellow survivors and a supportive community (www.BIAALCL.com). Today, Jennifer stands as one of the top advocates of the group, conducting outreach efforts to seek out other victims of this health issue. She is also an active voice in many leadership circles dedicated in the fight to bring public recognition and corporate accountability to this crisis. (See Jennifer's interview on Survivor Stories)

EDITORIAL TEAM 
Robert Bard, MD, PC, DABR, FASLMS has paved the way for the diagnostic study of various cancers both clinically and academically. His main practice in midtown, NYC (Bard Diagnostic Imaging) uses the latest in digital Imaging technology which has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered Sonograms, Spectral Doppler, sonofluoroscopy, 3D/4D Image Reconstruction and the Spectral Doppler are safe, noninvasive, and does not use ionizing radiation. His commitment to lead the community of cancer imaging and diagnostic experts has led to the establishment of the "Get Checked Now!" campaign.

Cheri Ambrose is a co-editor for various publications such as PinkSmart News, the Journal for Modern Healing and First Responders Cancer News.  She is a patient advocate for many cancer-related programs and often contributes her time in cancer research fundraising events.  As the communications director for the NY Cancer Resource Alliance, she manages community outreach, partnership missions with other cancer foundations and research organizations and attends educational functions for cancer awareness. Her latest public projects include the launch of ImmunologyFirst.org and ImplantScan.org.  She stands as the current President of the male Breast Cancer Coalition (MaleBreastCancerCoalition.org).

3) American Society of Plastic Surgeons: BIA-ALCL Resources | By the numbers, and what they mean. By Mark Clemens, MD https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/by-the-numbers
4) Modern Pathology:  https://www.nature.com/articles/s41379-019-0337-2

FROM CANCER LINK SUSPICION TO GLOBAL RECALL: BREAST IMPLANT ALCL REVIEW - THEN AND NOW

Edited by: Dr. Robert Bard & Cheri Ambrose Introduction The FDA (US Food & Drug Administration) first identified a possibl...