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The FDA has provided an update on breast implant-associated adverse effects, such as breast implant-associated anaplastic large cell lymphoma and breast implant illness.
The FDA has provided an update on breast implant-associated adverse effects (AEs), such as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII) that have been reported to the agency.1
The regulatory agency also cleared the BREAST-Q Reconstruction Module as a tool that can be used to assess certain medical devices, such as breast implants. The paper and electronic questionnaire can be used to evaluate a patient’s psychosocial, sexual, and physical well-being, in addition to satisfaction with their breasts.
“The FDA has been diligently monitoring AEs associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience in order to refine our evaluation of breast implant benefits and risks,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, stated in a press release.
“Our qualification of the BREAST-Q Reconstruction Module as a validated tool to assess outcomes of breast reconstruction surgery in terms of quality of life and satisfaction helps accomplish this,” added Ashar. “In addition, we continue to increase our scientific knowledge regarding BIA-ALCL, and systemic symptoms referred to as BII, and remain committed to keeping the public informed.”
The update includes global medical device reports for BIA-ALCL that were received through January 5, 2020. In this update, the FDA reported a total of 733 unique cases of BIA-ALCL with 36 related deaths globally, translating to an increase of 160 new cases and 3 deaths since a previous update issued by the agency in July 2019.
Of the 733 cases of BIA-ALCL reported to the regulatory agency, 620 cases involved Allergan implants and an additional 47 cases involved implants with an unknown manufacturer. Additionally, 496 cases had textured implants, while 209 cases did not specify the implant surface.
Of the 36 total deaths reported to the agency, 16 patients had information regarding the manufacturer of their implants. Moreover, 15 of those 16 patients were reported to have had an Allergan breast implant at the time of their diagnosis with BIA-ALCL. Additionally, of the 36 reported deaths, 16 cases had textured implants, while 19 cases did not have implant surface information available.
A type of non-Hodgkin lymphoma, BIA-ALCL is found in the scar tissue and fluid near the breast implant in most cases, although the disease is capable of metastasizing and spreading throughout the body. The overall incidence of developing this complication is low, but a diagnosis of BIA-ALCL is considered to be serious as this condition can result in death if not identified early and treated swiftly, according to the FDA.
“BIA-ALCL is a relatively new entity, so treatment modalities are evolving,” Lloyd B. Gayle, MD, told OncLive in a recent interview. “The cornerstone to this is understanding that with early diagnosis, specifically in patients with stage I/II disease where there is no spread beyond the breast, the capsule, and the surrounding soft tissue, treatment is best rendered with a total capsulectomy. This is now defined as an unblocked resection, which is to say the removal of the implant, the surrounding capsule, and any surrounding mass within the soft tissue.”
The majority of patients with BIA-ALCL can be successfully treated through the surgical removal of the implant and the surrounding scar tissue, but some patients may need chemotherapy and/or radiation therapy, according to the FDA update.
Of the 733 unique BIA-ALCL cases that were reported, the median age at the time of diagnosis was 53 years, with a median time from last implant to diagnosis of 8 years.2 The reason for implantation included augmentation (16%), reconstruction (17%), and not specified (67%). In terms of clinical presentation in the breast, it was found that 50% of patients had seroma, 26% had breast swelling/pain, 13% had capsular contracture, and 14% of patients had a peri-implant mass/lump; an additional 9% had another type of presentation and 28% were unspecified.
The FDA also shared data from unique BII medical device reports received between January 1, 2008 and October 31, 2019 in the United States and worldwide. The regulatory agency received a total of 2,497 medical reports that contained symptoms that proved to be consistent with BII between November 2018 and October 2019 alone. Additionally, data from January 2008 and October 2018 showed 1080 reports that contained symptoms of BII.
Although literature focused on BII is limited, symptoms that are often associated with breast implants include fatigue, memory loss, rash, “brain fog,” and joint pain. The symptoms most commonly reported to the FDA’s database for those with breast implants included fatigue (49%), brain fog (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (18%) autoimmune diseases (18%), inflammation (18%), and weight issues (18%). Although no clear evidence has indicated that breast implants cause these symptoms, current data indicate a resolution of symptoms following removal of the implants.
Through the regulatory agency’s Medical Device Development Tools program, an effort that was launched to quantify tools that medical device sponsors can utilize in the creation and assessment of medical devices, a self-administered questionnaire has received qualification.
The BREAST-Q Reconstruction Module was developed to assess a patient’s psychosocial, sexual, and physical well-being, along with satisfaction with their breasts; these questionnaires will be used to quantify different aspects of a patient’s quality of life and satisfaction with breast reconstruction surgery.
“These scales may be used by medical device sponsors and sponsor-investigators in feasibility, pivotal, and post-approval studies to support the effectiveness of breast reconstruction–related medical devices, such as an implant or mesh, befitting the clinical benefit meaningfulness of the scale to support the proposed indication,” the regulatory agency wrote in the release.