Commercial risk will be a critical catalyst of progress – it’s complicated, but is it possible? We think so.


February 11, 2019

Hundreds of cancer cases likely linked to breast implants, FDA warns

Daily Briefing

    FDA on Wednesday warned that there have been hundreds of confirmed cases of a rare cancer linked to breast implants, and at least nine patients have died from the disease since 2010.

    Access the Breast Cancer Tumor Site Dashboard


    FDA first reported an association between the cancer, called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implants in 2011. BIA-ALCL is not a breast cancer, but rather a type of non-Hodgkin's lymphoma found in scar tissue and fluid near implants.

    FDA explained, "When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a 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 contained within the fibrous capsule."

    FDA says hundreds of BIA-ALCL cases have been confirmed

    FDA in a letter sent Wednesday to health care providers wrote that the agency has confirmed 457 of the 660 unique cases of BIA-ALCL reported worldwide. The agency wrote, "Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL."

    FDA wrote that, in most BIA-ALCL cases reported to the agency, "patients were diagnosed … 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." As such, the agency said "all health care providers [should] be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy."

    FDA wrote that the collection of fluids or masses near the breast implants can cause the symptoms and lead to exams, which can diagnose BIA-ALCL. The agency said individuals with breast implants do not need "to change [their] routine medical care and follow-up."

    What FDA knows about BIA-ALCL

    FDA in the letter noted that a lack of data on the number of individuals who receive breast implants in the United States and internationally has made it difficult to determine the risks associated with breast implants. FDA said it is working with health care agencies and researchers to develop a better understanding of BIA-ALCL, but noted that most research demonstrates BIA-ALCL occurs in patients who have breast implants with textured surfaces, rather than smooth surfaces. However, FDA said BIA-ALCL cases have been reported among patients who have breast implants with smooth surfaces, as well. According to FDA, most medical device reports of BIA-ALCL do not indicate the implants' texture.

    FDA in the letter asked health care providers to continue reporting cases of BIA-ALCL to the agency. Binita Ashar, a general surgeon and director of the Division of Surgical Devices at FDA's Center for Devices and Radiological Health, in a statement said, FDA "want[s] to provide patients with the most up-to-date information about the variety of breast implants available so that patients and providers can have thorough and thoughtful discussions weighing the benefits and risks of different products."

    Ashar said FDA's General and Plastic Surgery Devices Panel plans to discuss BIA-ALCL during a public meeting in March (Miller, USA Today, 2/7; Gstalter, The Hill, 2/7; Shoot, Forbes, 2/7; Stahl, CBS Philly, 2/7).

    Webconference Thursday: Learn what trends are shaping the oncology market in 2019

    Demographic shifts, new treatment technologies, and reimbursement and regulatory changes have set the stage for a complex strategic planning process for your oncology service line. Join us on Feb. 14 to learn more about these trends, the key implications for providers, and how your organization can best respond.

    Register Now

    Have a Question?


    Ask our experts a question on any topic in health care by visiting our member portal, AskAdvisory.