On Feb. 6, 2019 the FDA issued an update on the number of cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALSC is a type of non-Hodgkin’s lymphoma (NHL) and is a known risk from breast implants. Unfortunately, the news was not good for women, especially for women with textured implants, in particular those sold by Mentor.
The update, 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 FDA had received a total of 660 medical device reports since 2010 and that 457 of those reports included a diagnosis of BIA-ALCL. Nine patient deaths were also reported.
As a result of these findings, the FDA sent communications to healthcare professionals explaining that BIA-ALCL is a type of lymphoma and not a cancer of the breast tissue, but that this is something that must be considered when evaluating the symptoms of women with implants.
According to the FDA letter to the treating community, “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.” The FDA felt the warning was needed because those presenting symptoms are all too often misdiagnosed with issues such as mastitis and are treated with antibiotics. Therefore, women risk delayed diagnosis unless they and their doctors are aware of the unusual symptoms associated with textured implants and BIA-ACSC.
There are varying estimates on the incidence of BIA-ALCL in women with implants, with estimated rates ranging from a high of one per 3,817 patients to a low of one in 30,000, the FDA said.
Regardless of how a woman came to have breast implants, either as a result of breast cancer or an expectation to look a certain way, we are concerned for every woman and one diagnosis of BIA-ALCL is too many.
If you are experiencing symptoms such as pain, swelling or asymmetry that developed after the initial surgical sites were fully healed, please contact your doctor as soon as possible.
If you would like to learn more about possibly taking powerful legal action that can help send a message to Mentor about this issue, contact A Case for Women for more information.