If you had breast implants and developed anaplastic large-cell lymphoma of the breast, contact our lawyers today for a free, confidential consultation. Several medical studies have linked breast implants, particularly textured breast implants like Allergan Natrelle, to an increased risk of developing anaplastic large-cell lymphoma (ALCL), a type of non-Hodgkin lymphoma. This page answers several frequently asked questions about the breast implant lymphoma lawsuits.
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What Do The Breast Implant Lawsuits Allege?
The current lawsuits are entirely different from the lawsuits in the 1980s and 1990s that alleged autoimmune and rheumatological complications from silicon breast implants. These new lawsuits allege that textured breast implants are contribuing to a rare type of lymphoma known as anaplastic large-cell lymphoma, and that the manufacturers knew or should have known of the risk. Most of the current lawsuits involve Allergan’s Natrelle products, particularly the Biocell Textured Breast Implants and Tissue Expanders. Some lawsuits involve textured breast implants made by Mentor and sold under the MemoryGel or MemoryShape lines.
Most ALCL diagnoses occur between 5 and 11 years after the implant, but some diagnoses have been reported as early as 2 years later and some 44 years later. Because Allergan Natrelle and Mentor MemoryGel were both approved in November 2006, and because Allergan Biocell sales weren’t stopped until 2019, we expect the number of breast implant ALCL lawsuits to continue rising over the next few years.
What Is The Status Of The Lawsuits? Have There Been Any Settlements? What About The FDA?
The breast implant ALCL litigation is still in early stages. None of the lawsuits filed have gone to a jury trial, and there are no publicly-disclosed settlements. Currently, a handful of cases are in the initial stage of briefing, with the plaintiffs’ lawyers and the company’s lawyers arguing over the legal issue of “preemption,” which is discussed in response to another question below.
Health organizations have recently taken action. In 2016, the World Health Organization updated its classification of lymphoid neoplasms, adding “breast implant–associated anaplastic large cell lymphoma,” also know has BIA ALCL, and that is the most common terminology used today. In March of 2019, the FDA held a public advisory meeting (a summary is available here) to discuss the risks of breast implants, including BIA ALCL. Soon after, the FDA issued a public safety communication warning about the risk of ALCL with breast implants, and request Allergan recall its BIOCELL products, which Allergan did. Then, in October, the FDA published a questions & answers document explaining its concerns about breast implants and anaplastic large-cell lymphoma.
What Is The Legal Issue With “Preemption?”
All of the textured breast implants are considered “Class III” or “PMA” devices, which means that the FDA pre-approved the device before it was sold. That’s not a guarantee of safety, but it means that the federal Medical Devices Act applies to them. Under section 360k of the federal Medical Devices Act, state law—which courts have said includes the state tort law that plaintiffs use to file lawsuits for damages—cannot be “different from, or in addition to, any requirement” from the FDA. As a result, for an injured plaintiff to bring a lawsuit, they must show that their claim is “parallel” to the federal requirements. That issue is complicated, and typically results in extensive briefing and arguments in court.
The preemption issue is still being litigated in breast implant cases. That is how I came to be involved in these lawsuits, and to take a closer look at the science and the facts. I’ve dealt with preemption several times in my career and so am often contacted by other lawyers for advice (and for speaking on panels, like this one in 2016 and this one in 2019). Another lawyer representing women with BIA ALCL asked me for some thoughts on the preemption issue, and I am still working with them today to help their clients, too, get their day in court.
Is There Scientific Evidence That Breast Implants Can Cause Anaplastic Breast Lymphoma?
Yes. More than 20 years ago, in 1997, oncologist Jack Keech, Jr., published an article describing a woman who had developed “anaplastic T-cell lymphoma in proximity to a saline-filled breast implant.” As Dr. Keech noted, there were numerous medical journal articles about saline implants and rheumatologic disorders, but “very little discussion in the literature regarding possible associations of inflammatory or neoplastic disease associated with saline-filled breast implants.” Up to that point, there had been scattered reports of T-cell lymphoma, but nothing as specific as Dr. Keech’s findings.
In 2008, pathologists in the Netherlands noticed two cases of ALK-negative anaplastic large T-cell lymphoma in the breast of patients with implants. The Netherlands has a database which tracks all histological and cytological diagnoses, so the researchers searched the database for “all patients with biopsy-proven primary non-Hodgkin lymphoma of the breast diagnosed between 1990 and 2006 in the Netherlands.” They found 11 cases in total, 5 of which had a breast implant. As they wrote, because ALCL is so rare, and because “primary lymphoma of the breast is mostly of B-cell type with 49% diffuse large B-cell lymphoma,” “the unusual distribution of this lymphoma type in case reports supports an association between ALCL and breast implants.” By their calculations, women with breast implants were 18 times more likely to develop ALCL. (Notably, this study included all breast implants, not just textured implants, and so the real increase in risk among women with textured implants is likely much higher, as discussed in this 2019 article.)
Some epidemiologists disputed the results, arguing that non-Hodgkin’s lymphoma in the breast was no more common in women with implants. But even they admitted other studies had looked at all forms of non-Hodgkin’s lymphoma and weren’t large enough to detect an increase in ALCL, and thus the study had shown “that among women with breast lymphomas in The Netherlands, those whose lymphoma is of the anaplastic, large cell type may be more likely to have received saline implants.”
In 2010, surgeons at the University of South California reviewed all of the “T-cell anaplastic non Hodgkins Lymphomas presenting as late seromas around breast implants” cases in the literature and found “[i]mplant information was available in 25 cases and 23 had the same textured shell characteristics, (McGhan-Allergan 18, Nagor 2: PIP 1,) which have a specific textured surface created by the lost salt method.” Later that year, a group of doctors from multiple specialties concluded “primary ALCL arising in close proximity to breast implants represents a distinct clinico-pathological entity,” and suggested that it should be considered a specific type of disease. Like the pathologists in the Netherlands, they were alarmed by how common this very specific type of lymphoma was in women with breast implants:
[Non-Hodgkin’s lymphoma] of the breast is very rare, with lymphoma involving the breast accounting for approximately 0.04–0.5% of malignant breast tumors and 2.2% of extra-nodal lymphomas. Furthermore, more than 90% of these are of B-cell lineage. Of the less than 10% which are of T-lineage, most are peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS). If the association between lymphoma and breast implants were purely co-incidental, one would expect the ratio of B-cell to T-cell lymphomas to be similar to that observed in women without implants, namely greater than nine to one. In fact, the ratio is reversed; of the more than 31 reported cases of primary breast lymphoma in close proximity to breast implants, only 3 are of B-cell origin.
By 2011, the FDA had received reports of 60 cases of ALCL in women with breast implants, and the FDA said it would collaborate “with the American Society of Plastic Surgeons (ASPS) and other experts in the clinical and scientific community to develop a registry of women with breast implants and anaplastic large cell lymphoma (ALCL) to better understand the nature and possible factors contributing to their association.” That same year, an FDA Advisory Committee recommended (1) expanding ongoing studies of breast implants to better understand rare side effects and (2) establishing “the National Breast Implant Registry (NBIR) and the PROFILE Registry (established to collect data on potential cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL)).”
But, apparently due to intervention from the implant manufacturers and the plastic surgery trade groups, neither effort got anywhere for several years. Instead, a literature review was conducted, and that review shockingly did not even attempt to review the evidence connecting breast implants with ALCL: “on the basis of discussions with our advisory panel, we did not evaluate anaplastic large cell lymphoma (ALCL).”
Other medical researchers continued to find that breast implants were causing ALCL, and in studies mapped out the course of the disease (in 2012) and the cell signaling (also in 2012). In 2013, a review of 103 ALCL cases in women with breast implants found “the type of implant is not always known, but where known is almost always a silicone-based implant with the surface textured,” and made specific recommendations for the types of tests to evaluate after a biopsy: “Upon encountering anaplastic lesions in patients with breast implants, the possibility of implant-associated ALCL should be a prime consideration justifying an initial panel of [pathology slides] that includes CD30, selected T-cell markers (eg, CD3, CD43, TIA-1), MIB1, and Alk-1.”
In 2018, the same team in the Netherlands that conducted the 2008 study updated their data, and incorporated data about the sales of breast implants. Although only 3-4% of women aged 20-to-70 in the Netherlands had a breast implant, 74% of the women who developed breast ALCL had implants. By their calculations, a woman with breast implants was 421 times more likely to develop ALCL of the breast. The researchers also noted that ALCL was even more common in women with macrotextured breast implants, such as those made by Allergan.
In March of 2019, and the first results from the “Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology” PROFILE registry were published. There were 186 cases, and “[a]ll patients had a history of a textured device; there were no patients who had a smooth-only device history.” Medical researchers are now pursuing information about the precise biological mechanism that causes ALCL in women with breast implants. Theories include friction triggering inflammation or an immune response, shell particulates or components leaching into the tissue, and the textured surfaces creating a haven for bacteria.
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