Textured Breast Implants Appear to Increase Risk of Anaplastic Large Cell Lymphoma
As far back as 2011, the U.S. Food and Drug Administration (FDA) began to discover a potential tie between breast implants and the development of a rare type of non-Hodgkin’s lymphoma known as anaplastic large cell lymphoma (ALCL).
In 2011, the federal regulators were aware of such a small amount of ALCL cases that the agency was unable to determine the factors that increased the lymphoma risks with breast implants. A report that summarized the agency’s findings focused on the need to collect additional information on how to better characterize ALCL in women with breast implants. The FDA indicated that it has bolstered its understanding of ALCL since 2011 and agrees with the World Health Organization’s (WHO) designation of breast implant-associated (BIA) anaplastic large cell lymphoma, also known as BIA-ALCL as a rare T-cell lymphoma that may develop following breast implants.
Unfortunately, the exact number of cases continues to be challenging to determine because of significant limitations in global reporting and a lack of global implant sales data. Currently, most data suggest that BIA-ALCL occurs most typically following implantation of breast implants with textured surfaces rather than smooth surface implants.
The FDA also noted that it will continue to collect and evaluate information about ALCL in women with breast implants and that on an ongoing basis it will receive and review medical device reports (MDRs) and current medical literature, exchange information with other international regulators and scientific experts, review data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE Registry) and the Plastic Surgery Foundation (PSF), and review information that breast implant manufacturers include concerning BIA-ALCL in their patient and health care professional labeling. The PROFILE Registry is a collaborative effort with the American Society of Plastic Surgeons (ASPS).
In 2016, a number of advances in the description of the disease and treatment recommendations were made. The first was that WHO recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants, according to the FDA. Also, professional organizations such as NCCN published data to assist doctors to understand BIA-ALCL, providing diagnosis and treatment. Also, regulatory bodies outside of the United States issued communications on BIA-ALCL. Specifically, the Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of 46 confirmed cases of BIA-ALCL that took place in Australia. Of these 46 women, three died. TGA estimated that the risk of developing BIA-ALCL to be between one-in-1000 and one-in-10,000 women with breast implants, noted the FDA. The French National Agency for Medicines and Health Products Safety (ANSM) sought to have the manufacturers of textured breast implants conduct biocompatibility testing and to report findings within one year. Biocompatibility testing determines how living tissue reacts to textured implants.
Parker Waichman LLP has spent decades representing clients in drug and medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a breast implant-associated ALCL lawsuit.
Medical Device Reports, Medical Literature
The agency indicated that it received 359 medical device reports (MDRs) as of February 1, 2017 involving BIA-ALCL. Of these, there were nine deaths, 231 reports that included information on the implant surface; 203 were reported to be textured implants and 28 were reported to be smooth implants. Most reports contained no information concerning the surface textures of any prior implants. Also, of the 359 reports, 312 reports included information on implant fill types and revealed that 186 reported implants were filled with silicone gel and 126 were filled with saline.
Currently, details on breast implant surface and fill type are limited and, although the MDR system is a critical source of data, the system may contain incomplete, inaccurate, untimely, unverified, or biased data, according to the FDA. The agency is confident that, going forward, it will accumulate more information about reports. Also, the incidence or prevalence of an event cannot be determined from the MDR reporting system because of the potential of under-reporting, duplicate reporting, and a lack of information concerning the total number of breast implants.
The FDA notes that much medical literature has been published since its 2011 report, including additional case histories and inclusive reviews of the natural history and long-term outcomes of BIA-ACLC. Most cases in medical literature describe a history of the use of textured implants associated with BIA-ACLC. Several recent journal articles have reviewed risk factors for BIA-ALCL, which have included the methods used to create implant surface texture and how biofilm may cause disease, among other issues. The information, to date, suggests that women with breast implants have a low but greater risk of developing BIA-ALCL when compared to women who do not have breast implants. Most cases of BIA-ALCL have been treated by removing the breast implant, as well as the capsule that surrounded the implant; some cases required chemotherapy and radiation.
FDA Recommendations to Health Care Providers and Patients
Health care providers are advised, in part, that if they have patients with breast implants, they should continue to provide them with routine care. BIA-ALCL has been identified most often in patients who are undergoing implant revision operations for late onset, persistent seroma or in patients with late onset of symptoms, including pain, lumps, swelling, or asymmetry. According to MedicalNewsToday, a seroma is buildup of fluids in a place in the body where tissue has been removed. The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.
The FDA advises patients to educate themselves about breast implants before undergoing breast implant surgery and to note that breast implants approved in the United States may be filled with either saline or with silicone gel, come in various sizes and shapes, and have either smooth or textured surfaces (shells). For patients with breast implants, the FDA does not recommend changing routine medical care and follow-up. The FDA also recommends to continue following physician instructions and to contact their physicians if there is a change. Routine mammography is recommended, as usual and, also as usual, patients with breast implants should receive a mammography from a technologist specifically trained in performing mammograms on patients with breast implants. Patients with silicone, gel-filled breast implants should undergo periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by their physicians. The FDA-approved product labeling for silicone gel-filled breast implants indicates that the first MRI should occur three years after implant surgery and every two years thereafter.
Filing a Breast Implant Lymphoma Lawsuit
If you or someone you know is interested in filing a personal injury lawsuit over breast implant lymphoma, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).