FDA Updates Analysis of Adverse Events for Breast Implant Illness and Implant-Associated Lymphoma

The FDA announced updates to an analysis on adverse events pertaining to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to by patients as breast implant illness (BII), according to a news release from the FDA.

More, the FDA qualified the BREAST-Q Reconstruction Module as a medical device development tool (MDDT) to aid in their assessment of specific medical devices such as breast implants. These qualifications included physical well-being, psychosocial well-being, sexual well-being, and satisfaction with breasts scales.

“The FDA has been diligently monitoring adverse events 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 Center for Devices and Radiological Health, said 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.”

The updated analysis included reports received through January 5, 2020, showing a total of 733 unique cases and 36 patient deaths globally, an increase of 160 new cases and 3 deaths since the July 2019 update.

Of the 733 cases of BIA-ALCL reported, 620 cases were reported for Allergan implants with 47 cases involving implants from an unknown manufacturer. For the implant surface, 496 cases had textured implants, while 209 cases did not specify surface type.

In regard to the 36 patient deaths, 16 cases reported textured implants while 19 cases did not contain information on the implant surface. More, 15 of 16 patients with implants from an unknown manufacturer were reported to have had an Allergan breast implant at the time of diagnosis.

“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,” Ashar said.

As for the BREAST-Q Reconstruction Module, the self-administered questionnaire is used to quantify aspects of a woman’s quality of life and satisfaction with breast reconstruction surgery. The scale can be used 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 meaningfulness of the scale to support the proposed indication.”

While BIA-ALCL is not breast cancer, the form of non-Hodgkin's lymphoma is found in the scar tissue and fluid near the implant. Many BIA-ALCL diagnoses are serious and can potentially lead to death if not diagnosed early enough or properly treated. Most patients are successfully treated for the disease with a surgery to remove the implant and scar tissue.

Reference:

FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma [news release]. Published August 20, 2020. https://www.fda.gov/news-events/press-announcements/fda-updates-analysis-medical-device-reports-breast-implant-illness-and-breast-implant-associated. Accessed August 21, 2020.