FDA Provides Updated Analysis of Breast Implant-Associated Lymphoma, Breast Implant Illness

The Food and Drug Administration (FDA) provided an update on breast-implant associated side effects that have been reported to the agency, including breast implant-associated anaplastic large cell lymphoma (BI-ALCL) and symptoms that are commonly referred to by patients as breast implant illness (BII).

In addition to the breast implant-associated side effect update, the agency also approved a validated, self-administered questionnaire to quantify different aspects of a woman’s quality of life and satisfaction with breast reconstruction surgery. Known as the Breast-Q Reconstruction Module, there is a paper and electronic questionnaire that assess a patient’s psychosocial, sexual and physical (chest) well-being, as well as their satisfaction with their breasts.

“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,” said Dr. Binita Ashar, director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, 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. 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.”

Updated Report of Breast Implant-Associated Anaplastic Large Cell Lymphoma

The FDA has updated its last public report involving BIA-ALCL with new information from July 7, 2019 to January 5, 2020. There have now been 733 unique cases of BIA-ALCL reported to the agency and 36 deaths around the world. Those totals reflect an increase of 160 new cases and three deaths since the most recent report.

If not diagnosed early and treated immediatey, a BIA-ALCL diagnosis can lead to death, according to the agency. The implant-associated disease is often treated with surgery to remove the implant and surrounding scar tissue. However, the agency notes, that there are instances where patients may require chemotherapy and/or radiation therapy to treat the BIA-ALCL.

More Patients Report Breast Implant Illness

The FDA has also updated a table on its website that summarizes medical device reports attributed to breast implant illness. The new information shows that the agency received 2,497 reports associated with symptoms consistent with breast implant illness from November 2018 to October 2019. As a reference, the available data the agency received in a previous 10-year period (Jan. 2008 to Oct. 2018) identified 1,080 reports associated with breast implant illness.

The FDA attributes the increase in reports of conditions considered breast implant illnesses to more awareness from the press and social media, as well as the agency’s General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.

Some of the common symptoms considered to be associated with breast implant illness reported to the agency include, but are not limited to, fatigue (49%), brain fog (25%) and joint pain (25%).

The FDA does note that although the agency lacks definitive evidence associated breast implants these symptoms, evidence suggests that some patient’s symptoms are resolved when the implants are removed.

Information on What Patients Should Know

The FDA also released a video for patients that details seven things they should know about breast implants, including information about BIA-ALCL and systemic symptoms.

The agency noted in the release that it will continue to provide information regarding the risks associated with breast implants, as well as routinely update the BIA-ALCL and breast implant illness analysis published on its website.