JALBCA celebrated its 2019 Awards Presentation Dinner on May 6, 2019 at The Ziegfeld Ballroom with over 650 friends and supporters. That evening JALBCA broke all prior fundraising records, thanks to our generous sponsors and other donors. At the dinner, JALBCA presented the Maite Aquino Memorial Grant Award to Lucy Fato, AIG’s Executive Vice President and General Counsel, and the AIG Global Legal, Regulatory and Compliance Department. JALBCA’s Honorary President and Chief Judge of the New York Court of Appeals, Hon. Janet DiFiore, presented the Leadership Achievement Award to the entire Appellate Division, First Judicial Department. Co-Presidents Vilia Hayes and Hon. Michael Katz participated in the program. Last year’s recipient of the Leadership Achievement Award, Hon. Paul Feinman, administered the oath of office to incoming Co-President Hon. Saliann Scarpulla.
At the dinner, JALBCA unveiled a new video showcasing the great work done by JALBCA and its grantees. Additionally, the dinner featured a beautiful video tribute to two prominent JALBCA members, Hon. Shirley Werner Kornreich and Edward Kornreich, both of whom are past JALBCA Co-Presidents. Justice Kornreich has also served in multiple other capacities since JALBCA’s formation, including as a longtime Co-Chair of the Symposium Committee (together with past Co-Presidents and Co-Chairs Mikki Golar and Barbara Ryan), Co-Captain of JALBCA’s Komen Race for the Cure team (together with Co-Captain Sandra Lespinasse), member of the Grants Committee and member of the JALBCA Hotline where, together with other members including Hon. Karla Moskowitz and Hon. Paula Omansky, she responded to calls from members of the legal community about their concerns about breast cancer. Edward Kornreich similarly has also served JALBCA in other capacities, with noteworthy contributions as Treasurer of JALBCA and Chair of the Audit/Finance Committee. Their combined service has spanned the decades of JALBCA’s existence and their contributions have been invaluable.
Both videos and photos of the event can be viewed on the JALBCA website at http://jalbca.info/events/annual-awards-presentation-dinner-2019/.
On March 26, 2019, JALBCA presented its annual Ellen P. Hermanson Memorial Symposium, “Mammograms on Trial”, at the Ceremonial Courtroom in the Daniel Patrick Moynihan U.S. Courthouse. In this “trial” of an imaging center director, esteemed legal and medical professionals explored whether, from a public health perspective, routine screening mammograms of otherwise healthy women are sufficiently “medically necessary” to permit reimbursement with public health dollars. Hon. Colleen McMahon, Chief Judge of the U.S. District Court, Southern District of New York, presided over the “trial.” Participating counsel included Rita M. Glavin, Esq. (Seward & Kissel LLP), Judith A. Livingston, Esq. (Kramer, Dillof, Livingston & Moore), Katherine Ginzburg Treistman, Esq. (Greenberg Traurig LLP) and Lauren J. Wachtler, Esq. (Phillips Nizer LLP). Participating as expert witnesses were Barry Kramer, MD, MPH (former Director, Division of Cancer Prevention, National Cancer Institute) and Laurie Margolies, MD, FACR, FSBI (System Chief of Breast Imaging, Mount Sinai Health System and Professor of Radiology, Icahn School of Medicine at Mount Sinai). Symposium sponsors included The Ellen Hermanson Foundation and The Bench and Bar of the SDNY. JALBCA also was joined by Supporting Organizations – The Federal Bar Council and The Women’s Bar Association of the State of New York. JALBCA’s Symposium Co-Chairs included Sandra Lespinasse, Esq., Hon. Saliann Scarpulla, Hon. Leslie A. Stroth, and Virginia K. Trunkes, Esq.
The litigants tested the limits to which screening mammograms are “medically necessary,” using as a backdrop the money reimbursement framework of the Medicaid program. Because that program is federally funded, false submissions are subject to the False Claims Act, 31 U.S.C. 3729-3733, pursuant to which any person who knowingly submits false claims to the government is liable for a multiple of the government’s damages plus a penalty of thousands of dollars for each false claim. In the “trial”, the director of the imaging center was being sued by the government for violating the False Claims Act based on his alleged practice of over-screening clients and seeking reimbursement.
New York defines the “medical assistance” to be provided under the Medicaid program to include payment for medically necessary medical, dental and remedial care, services and supplies, as authorized by this title or the regulations, which are necessary to prevent, diagnose, correct or cure conditions in the person that cause acute suffering, endanger life, result in illness or infirmity, interfere with such person’s capacity for normal activity, or threaten some significant handicap and which are furnished an eligible person in accordance with this title and the regulations of the department. N.Y. Soc. Serv. Law § 365-a(2).
The trial drew on relevant case law to address the issues presented and CLE materials were distributed to attendees. The event was thoroughly engaging and attendees were delighted to hear their fellow JALBCA members and colleagues argue the merits before Chief Judge McMahon. The program was followed by a delicious and lavish networking reception hosted by the Bench and Bar of the SDNY.
Worldwide Breast Implant Recall
On July 24, 2019, the FDA issued a safety communication reporting that it had requested Allergan to voluntarily recall Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients.
The FDA requested that Allergan recall these items marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of a rare cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market. These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan. A list of Allergan’s BIOCELL textured devices marketed in the U.S. that will be voluntarily recalled can be found at the FDA link, https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue.
The FDA’s analysis followed a worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of these 573 cases, 481 were reported to have Allergan breast implants at the time of diagnosis. Further, 12 of 13 deaths occurring in patients with BIA-ALCL, where the manufacturer was known, occurred in patients with an Allergan breast implant at the time of their BIA-ALCL diagnosis. As to the remaining 20 reported deaths from BIA-ALCL, the manufacturer and/or texture is unknown. BIA-ALCL is not breast cancer but, rather, is a type of non-Hodgkin’s lymphoma (cancer of the immune system).
The FDA concluded, based on the data then available, that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. They further concluded that continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.
The FDA announced that it would continue to evaluate any new information. This may lead it to take action as to other breast implants, if warranted. Although most cases of BIA-ALCL are associated with the use of textured breast implants, particularly macro-textured implants – such as those made by Allergan – the FDA plans to continue its assessment in order to determine whether the risk of developing BIA-ALCL is limited to only specific models of textured breast implants. At the time of its announcement, the FDA advised that it believes all individuals who are considering a breast implant of any type should be informed of the risk of developing BIA-ALCL.
In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant. In some cases, it can spread throughout the body. At this time, while the overall incidence of developing BIA-ALCL is considered to be low, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. Reportedly, in most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant. Some patients, however, may require treatment with chemotherapy and/or radiation therapy.
The FDA offered recommendations to those who have Allergan BIOCEL breast implants, as follows:
- If you have no symptoms, the FDA does not recommend removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. Questions should be raised with your health care provider.
- Know the symptoms of BIA-ALCL – primarily persistent swelling or pain near the breast implant – and monitor the area around your breast implants for any changes.
- If you experience any of these symptoms or other changes, talk to your health care provider about the need for further evaluation. This likely involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. A confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.
- Based on discussions with your health care provider, patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule. This is a more extensive operation than only implant removal.
- Any implant patient should keep a record of the device manufacturer, unique device identifier, and implant model name. This information can be found on a patient device card from your surgeon. If you do not have that card, consider asking your surgeon or obtaining the record of your surgery (operative notes) from the facility where it was performed.
- Discuss your risk of developing BIS-ALCL with your surgeon. Most cases of BIA-ALCL occur many years after breast implant placement.
In addition, the FDA provided recommendations for health care providers, as follows:
- Immediately stop using (implanting) Allergan BIOCELL breast implants; and work with your facility to return existing inventory.
- At this time, the FDA does not recommend removal of these or other types of breast implants in patients who have no symptoms, due to the low risk of developing BIA-ALCL.
- Inform your patients about the risk of developing BIA-ALCL and what to look for.
- Prior to implantation of any breast implant, provide your patients with the manufacturer’s patient labeling, as well as any other educational materials, and discuss the benefits and risks of the different types of implants.
- Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant changes. In some cases, patients presented with a seroma, mass, hardening adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, ensure an evaluation is conducted by experts familiar with the diagnosis and treatment of BIA-ALCL.
- Collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Additional details about the diagnostic evaluation were provided by the FDA.
- Develop an individualized treatment plan considering current clinical practice guidelines, such as those from the Plastic Surgery Foundation of the National Comprehensive Cancer Network (NCCN) External Link Disclaimer when choosing your treatment approach.
- Report all cases of BIA-ALCL in individuals with breast implants to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
- Submit case reports of BIA-ALCL to the Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology (PROFILE) Registry External Link Disclaimer to contribute to a better understanding of the causes and treatments of BIA-ALCL.
In addressing patients’ concerns, the FDA noted that the macro-textured implants, such as the BIOCELL ones, represent less than 5% of breast implants sold in the U.S. Textured implants, in total, account for only 10% of all breast implants sold in the U.S. The FDA’s action is similar to other actions initiated by France, Canada and Australia, where the use of textured implants is much higher, sometimes as high as 80% of their market share. These countries have also initiated or taken actions to prompt the recall or removal of certain textured breast implants (including certain breast implants sold by Allergan) from the market. In 2011, the FDA first identified a possible association between breast implants and the development of BIA-ALCL.
Reporting Problems with a Medical Device
If you suspect or experience a problem with a medical device, the FDA encourages you to use the MedWatch Voluntary Reporting Form to report the problem. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
The FDA Addressed Questions
Patients with questions were urged by the FDA to take the following actions:
- Talk to your health care provider about questions regarding BIA-ALCL.
- Ask your surgeon or obtain the record of your surgery (operative notes) from the facility where it was performed to find out if you have the affected products.
- For specific questions about the recalled products, contact the manufacturer, Allergan, at IR-Medcom@nullallergan.com or call 1-800-678-1605 option #2.
- For general questions about the recall, contact the Division of Industry and Consumer Education (DICE) at DICE@nullFDA.HHS.GOV or call 800-638-2041 or 301-796-7100
Numbers of Patients Affected
Hundreds of thousands of women are estimated to have these implants, according to Dr. Binita Ashar, director of the office of surgical and infection control devices at the FDA. Breast augmentation was the most popular cosmetic surgical procedure performed last year, according to statistics from the American Society of Plastic Surgeons. However, while most women have breast implants with no serious complications, the FDA advises that as many as 20% of women who receive implants for augmentation have to have their implants removed within eight to 10 years, due to complications.
The Ellen Hermanson Foundation celebrated the 24th annual Ellen’s Run on August 18, 2019. Ellen’s Run is an annual 5K (3.1-mile) race/walk that benefits breast cancer patient support services in the East End community of Long Island. Proceeds from Ellen’s Run enable the Foundation to continue Ellen’s work by funding projects that provide educational outreach and early detection for underserved communities and psychosocial support for breast cancer patients and their families.