Recall Alert:
Implant Associated Cancer

Since the "Get Checked Now!" project first launched its public Implant Safety awareness mission alongside several women's groups on Aug. 2018 to publish health alerts about BIA-ALCL /Breast Implant Associated cancers, (see: https://patch.com/new-york/huntington/growing-cancer-risks-certain-implants-survivors-take-action) recent news finally broke as of July of this year that ALLERGAN, the world's largest manufacturer/distributor of textured implants that they have finally bowed to the pressures of implementing a voluntary global recall of the BIOCELL® implant & tissue expander. Due to FDA's published evidence that these textured implants are being linked to a growing rate of non-Hodgkins lymphoma leading to potential death, the implant producer has undergone serious pressures and a battery of complaints worldwide causing the first government proposed BAN on the devices from Australia's Therapeutic Goods Administration. This and other public actions from the medical community and the millions of concerned implant recipients about the rising numbers of cancer cases have led to a going-forward RECALL of the BIOCELL® model (textured)- as the first major touchdown in the fight for public safety. The FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients and Allergan's recall does not affect any other breast implant products including the NATRELLE® smooth or the MICROCELL® implants. (see full FDA release: https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan)

 

"GET CHECKED NOW!" and the Public Access Program for Advanced Cancer Screening & Diagnostics (CSDS)

(BETA- This program is not officially active- please check back soon)

For New York residents who are having financial difficulties affording a second opinion outside of their current healthcare plan- or show income restrictions to pay out of pocket for advanced imaging or cancer diagnostic services, you may qualify for THE ANGIOFOUNDATION CSDS grant. The AngioFoundation partners with other cancer funding sources and research groups to bring full or partial financial aid to cancer-related emergencies. Our outreach program conducts outreach efforts and helps to complete the application process toward receiving screening & cancer scanning care. The "GET CHECKED NOW!" project was established in 2017 by the founders of NYCRA (The NY Cancer Resource Alliance) and was originally launched as a public awareness mission to bring vigilance and proactive attention to getting regular health checkups. This mission promotes early detection and prevention of cancer by raising the level of public health priority by identifying the many forms of cancer plaguing our society today.

Click HERE for more information on the IMPLANTSCAN FUND or POST-CANCERSCAN GRANTS

"Get Checked Now!" also stays current with all public emergencies, occupational hazards, geographic carcinogens, medical recalls and other widespread health concerns.

 BIA-ALCL IN THE NEWS

 

Recall Validates Health Crisis about "Killer Implants"
The official recall of the Biocell® model (textured implant) by Allergan on July 24, 2019 is seen as a landmark win for the many health & safety advocates who have always known about the risks of large cell non-hodgkins lymphomas from breast implants. "...I was grateful that the chance that future women will develop this lymphoma has been greatly reduced", states co-founder Jennifer Cook of BIAALCL.com. "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."

Throughout social media and the news, a significant outcry about this type of implant has been directly linked to cancer, but having the FDA statement instigated action on the side of the pharmaceutical company.

SYMPTOMS of BIA-ALCL

(Source: BIAALCL.COM)

Knowing the signs and symptoms of BIA-ALCL can help early diagnosis and saves lives.

BIA-ALCL involves the proliferation of lymphoma cells in or around a breast implant scar capsule. This proliferation will usually also involve the development of fluid around the implant and/or an increase in the thickness of the scar capsule surrounding the implant. As a result of these changes, the symptoms of BIA-ALCL can include but are not limited to the following:

• A change in breast shape or implant shape;
• An increase in breast size;
• The development of or an increase in breast asymmetry;
• A change in the way the breast feels such as an increase in firmness;
• Pain in or around the breast;
• The development of a lump or lumps in or around the breast or under the armpit;
• Swollen lymph nodes;
• Itching or redness of the skin on or near the breast;
• Lesions on the skin on or near the breast;
• Fluid around the implant seen on imaging such as ultrasound and/or MRI;
• Masses or areas of increased thickness of the scar capsule around the breast implant as seen on imaging;
• Fever;
• Severe fatigue; and
• Nightsweats.

It is important to know that some of the symptoms of BIA-ALCL are similar to other conditions, including those of other implant-related conditions such as capsular contracture. If such symptoms are present, BIA-ALCL can only be ruled out by having fluid and/or tissues examined by a pathologist following the NCCN guideline testing protocols.

 
INSURANCE COVERAGE INFORMATION FOR BREAST IMPLANT REMOVAL

The original reason for getting your breast implants matters to health insurance companies (as well as Medicare and Medicaid). If your implants were put in after a mastectomy and your doctor believes that removing your implants is “medically necessary,” then your health insurance is legally obligated to cover your breast implant removal under the Women’s Health and Cancer Rights Act of 1998 (WHCRA). If the original reason for getting breast implants was for augmentation of healthy breasts, then some health insurance companies will cover your explant surgery if they consider the services to be “medically necessary.”

WHAT ARE “MEDICALLY NECESSARY” SERVICES?
Insurance companies cover services that they determine to be “medically necessary” to treat a disease or illness. Although you or your doctor may believe a service is medically necessary, insurance companies don’t always agree. Most insurance companies will not cover any cosmetic procedures and some will not cover complications from previous cosmetic procedures. However, many companies consider removal of breast implants medically necessary for patients with a select list of conditions: (see complete article)

Additional topics:
• How do I know whether my insurance company will cover the cost of removal?
• What Do I Look For?
• File for Pre-Authorization
• After Your Surgery: Filing a Reimbursement Claim
• What if I have Medicare?
• What do I Need to Know about Breast Implant Removal Surgery?

 
 

Research results in APPLIED SCIENCE

IMAGING ASSISTS SURGICAL PLANNING OF INDICATED BIOPSIES

In my extensive career as the medical director of an advanced imaging diagnostics practice, I have provided great assistance to many surgeons with my work using advanced Doppler Scanning of Tumors and Cosmetic Disorders. I have uncovered countless dermal and subcutaneous issues that would have otherwise gone undetected with less effective technologies, leading to potential complications in the surgical procedure and patient recovery. The advancement in this innovation empowers upcoming surgical procedures with remarkable confidence of a safer end result. Where biopsies are becoming a thing of the past, our non-invasive 4D Digital imaging replaces weeks of lab work and radiologic tests and often provides more useful information. (see complete article)

DIGITAL BIOPSY CASES: WHAT ARE YOU ABOUT TO BIOPSY? WHAT HAPPENS AFTER THE NEEDLE INSERTS? Here we have 2 subdermal masses which are non tender and firm with no history of trauma. Case A: The oval mass (dark echoes=suspicious) with irregular vessels (red) was referred as a probable cyst or lipoma. The tumor is highly vascular and connected from the aorta by way of the subclavian feeding artery. Liposuction could result in massive hemorrhage and spread of tumor cells into the circulation.

 

Case B: The ovoid white region (bright echoes=benign) is ossified as confirmed by the CT scan of the coccyx. The sonogram allows you to reassure the patient it is NOT CANCER. It prompts one to avoid a standard needle that could bend, crack or dislodge into the soft tissues requiring further exploration to locate/retrieve the broken metal fragment.
 

Contributing to the evolution of SCIENCE

The study of medicine is an ongoing stream of new discoveries that continue to shape the very way we approach PROBLEM SOLVING. The Biofoundation for Angiogenesis Research and Development also known as The ANGIOFOUNDATION (501c3) funds and supports specialized clinical research projects that underscore the future of how physicians and scientists identify disorders and the resources that pave new heights in efficiency and performance with the least possible risk.

Since its official launch in Dec., 2001, the AngioFoundation was committed to conducting various disciplines of clinical research to support the advancement of technologies, treatment protocols and diagnostic science. Founder Dr. Robert L. Bard's research concept was establishing the exploratory study of minimally invasive modalities to treat cancer and inflammatory arthritis by analyzing "angiogenesis" or new blood vessel (angio) formation (genesis). Major international congresses* showed tumor blood vessel formation revealed by sonogram Doppler imaging was the best predictor of cancer aggression. Treatment success is validated when abnormal arteries decrease in number after therapy. Treatment failure may be demonstrated earlier with this test allowing alternate therapies to be applied. The AngioFoundation has also expanded its research work through collaboration with global technology developers or modern laser innovations, MRI's & ultrasound technologies to detect and treat prostate, breast, thyroid and skin cancers non-invasively. The AngioFoundation's public mission is to advance image guided diagnostic and therapeutic technologies worldwide and supports teaching programs for physicians on new modalities to diagnose and deliver therapies for cancer and allied diseases including inflammatory arthritis.

* (AIUM2019 ICIS2018, ASLMS2019 and RSNA2018)
 

AngioFoundation Health & Safety PROGRAMS
(BETA- This program is scheduled to launch by the fall of 2020)

The AngioFoundation is committed to philanthropic efforts and health/safety services pertaining to ALL CANCER ALERTS in our community.We are founded on the principles of front-line response to environmental emergencies, health epidemics and product hazards and recalls that affect a widespread group of victims. We support the community at large through the following key programs:

• PUBLIC ACCESS TO ADVANCED CANCER SCREENING & DIAGNOSTICS

• FUNDRAISING FOR CLINICAL RESEARCH, TRIALS & SCREENINGS & SCREENINGS

• CANCER EDUCATION, PUBLIC OUTREACH & AWARENESS PROJECTS

• SCHOLARSHIPS, GRANTS & DONOR CONTRIBUTIONS

• CAREGIVER NETWORK SUPPORT FOR PROFESSIONALS MANAGING CHRONIC DISORDERS

 
 

Since its official launch in Dec., 2001, the Biofoundation for Angiogenesis Research and Development (aka AngioFoundation - 501C3) was established to conduct various disciplines of clinical research to support the advancement of technologies, treatment protocols and diagnostic science. The AngioFoundation has since been recognized worldwide by official medical organizations and peer reviews for its work in various cancer diagnostic focal studies and class divisions. We continually maintain and update research work in these categories to support the advancement of these disciplines as part of The AngioFoundation's commitment to the scientific community. In addition, the AngioFoundation's public mission also pursues education and awareness efforts pertaining to cancer topics as they affect our community at large. https://angiofoundation.org/

 
  CLINICAL ADVISORS & TECHNICAL CONTRIBUTORS
 
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.
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. (See Dr. Clark's interview on PinkSmart News)
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)
Jennifer Hunt is one of Long Island's top patient advocates and fundraisers for cancer research through her group "Fight Cancer like a Girl" (a partner of LI2DAY Foundation). She is a breast cancer survivor since having been diagnosed in 2010. After having undergone reconstructive surgery with textured implants, Jennifer discovered herself to be at risk for BIA-ALCL. She used this as a platform to raise public awareness through the media to alert all women about this possible health hazard by joining NYCRA as a voice for "Getting Checked Now!" and maintaining a strong public presence for education and a proactive lifestyle which includes PREVENTION and regular EARLY DETECTION scans. (More about Jennifer's survivor story)
Constantine Kaniklidis is an oncology researcher specializing in breast cancer, with focus on the most challenging advanced/metastatic disease including visceral (lung, liver) disease, triple negative breast cancer (TNBC), and CNS (brain and leptomeningeal) metastases, and a published author of papers in breast oncology, currently serving as the Director of Medical Research for the No Surrender Breast Cancer Foundation (NSBCF). He is presently engaged in extensive evidence-based medicine (EBM) research in oncology for prevention & therapeutics while in pursuit of epigenetic reprogramming, drug interactions and resistance, and evidence-based integrative oncology. (See his latest article in PinkSmart news)
Jesse A. Stoff, MD, MDH, FAAFP is a highly-credentialed medical expert studying all medical remedies in pursuit of resolving the most challenging health issues of our time. In many circles, he is recognized for his 35+ years of dedicated work in immunology and advanced clinical research in modern CANCER treatments. He has spoken worldwide in some of the most sought-after medical conferences about his experiences and analyses on the study of human disease. His integrative practice INTEGRATIVE MEDICINE OF NY, Westbury, NY) has been continually providing all patients with the many comprehensive clinical options and modalities available- including "ONCO-IMMUNOLOGY". (See Breast Implant news feature)
Stephen Chagares, MD, FACS is a seasoned breast cancer surgeon in Tinton Falls, New Jersey and a global pioneer in advanced robotic procedures. He is a major supporter of post-surgical health maintenance for all patients especially cancer survivors who underwent reconstructive surgeries. His commitment to the continued evolution of modern medicine supports the development of protocols to use advanced ultrasonic screening solutions for all mastectomy patients and implant users. - (see complete feature article)
Jessica A. Glynn is a psychotherapist and professional coach. Jessica works with individuals and their loved ones suffering from debilitating anxiety that arises from the trauma of receiving a life altering medical diagnosis. She has seen clients with extreme feelings of being out of control after their body has seemingly betrayed them and have had to largely lean on others for support and help. Jessica believes there are effective ways to be vigilante in prevention of disease like seeing Dr. Bard, whom is so very dedicated to his exploration of the latest diagnostic technologies and work toward preventive care. However, she recognizes that there are also areas of limitation for our vigilance.She understands that the fear may never fully dissipate, but the hours and days that one can be present and focused on now are the hours and days that individuals are truly living.
 

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