• FDA Warns of Increased Lymphoma Risk From Breast Implants

    Agency Offers Guidance for Health Care Professionals

    February 25, 2019, 08:12 am News Staff – On Feb. 6, the FDA issued a statement providing an update on the number of cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma and a known risk from breast implants. 

    The statement, provided by Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health, reported that as of Sept. 30, 2018, the agency had received a total of 660 global medical device reports (MDRs) regarding BIA-ALCL cases since 2010.

    Of the 660 MDRs, the FDA's analysis found 457 unique cases of BIA-ALCL, including nine patient deaths.

    Additionally, the FDA issued a letter to health care professionals that encourages those who regularly treat patients, including family physicians, to learn about the risk of BIA-ALCL in patients with breast implants.

    Radiology tech viewing mammogram

    "We want to ensure that all providers who treat patients with breast implants have information regarding identification, diagnosis and treatment," Ashar said in the statement. "Patients are more likely to seek routine care from primary care physicians, gynecologists and others besides their treating plastic surgeon. By providing information to health care providers, we believe more providers will be empowered with information to assist patients who may have BIA-ALCL."

    The FDA also encouraged health care professionals and patients to file MDRs with the FDA's MedWatch program.

    In its letter to health care professionals, the agency said, "We want all health care providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy."

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    BIA-ALCL Background

    The FDA's letter to health care professionals explained that BIA-ALCL is a type of lymphoma and not a cancer of the breast tissue. Breast implants are inserted behind the breast tissue or under the chest muscle, the agency said.

    As time passes, a fibrous capsule develops around the implant, separating it from the rest of the breast. In patients with breast implants, reported cases of BIA-ALCL were generally found adjacent to the implant itself and were contained within the fibrous capsule.

    According to the letter to physicians, "In most of the cases reported to the FDA, patients were diagnosed with BIA-ALCL when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling or asymmetry that developed after their initial surgical sites were fully healed."

    These symptoms were due to seroma or masses surrounding the breast implant, the agency noted, saying examination of the fluid and capsule surrounding the breast implant led to the BIA-ALCL diagnosis.

    A significant body of medical literature has been published since the agency's 2011 report on BIA-ALCL, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of BIA-ALCL.

    Current literature offers varying estimates on the incidence of BIA-ALCL, with estimated rates ranging from a high of one per 3,817 patients to a low of one in 30,000, the FDA said.

    Although most patients who develop BIA-ALCL have had textured implants, according to the letter, there have been reported cases of BIA-ALCL in patients with smooth-surfaced implants, and many of the reports haven't included surface texture of the implant at the time of diagnosis.

    "Recent journal articles explore possible risk factors for developing BIA-ALCL, including the methods used to create the textured surface and the role of biofilm," the letter said. "Additionally, most of the published information about treatment describes removal of the implant and the capsule surrounding the implant, and in some patients, treatment with chemotherapy and radiation."

    Finally, the agency noted that although the number of identified cases of BIA-ALCL remains small compared to the estimated 1.5 million patients who receive breast implants worldwide each year, "confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL."

    Recommendations for Family Physicians

    The FDA's letter to health care professionals included the following recommendations:

    • Before implantation, provide all patients with the breast implant manufacturer's labeling, including the patient-specific labeling, as well as other educational material, and ensure they are aware of 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 seroma or one who presents with a mass or masses adjacent to the breast implant. Refer patients with suspected BIA-ALCL to a multidisciplinary team for evaluation.
    • Collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid or mass with Wright Giemsa-stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation and anaplastic lymphoma kinase markers.
    • Develop an individualized treatment plan in coordination with the patient's multidisciplinary care team, considering current clinical practice guidelines when choosing a treatment approach.
    • 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 to contribute to a better understanding of the causes and treatments of BIA-ALCL.

    Additional Details

    Ashar noted in the FDA statement that the number of unique cases is lower than the total number of reports because the agency's medical device reporting system allows patients, clinicians and manufacturers to each file their own reports even if it's about the same case, which can lead to duplicative reports of BIA-ALCL.

    "Our analysis of these reports is better when there is a wide range of information provided concerning the breast implant texture and implant fill, and other helpful details like a patient's age, how long a patient has been implanted and time from implantation to diagnosis," Ashar said. "This information helps us understand how and why this lymphoma may be occurring."

    Ashar said BIA-ALCL will be discussed at the FDA's upcoming General and Plastic Surgery Devices Panel meeting on March 25-26.

    "The FDA continues to actively work alongside the American Society of Plastic Surgeons, international regulatory agencies and other experts in the clinical and scientific communities to evaluate all available information to understand the nature and possible factors contributing to BIA-ALCL in patients with breast implants," Ashar concluded.

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