The FDA today reported that it has received nearly 2,500 new reports globally of “breast implant illness” or BII. Reports of new breast implant-related cancer were also up.
BII is not cancer, nor is it a term often found in medical literature, the agency said. But it is frequently used by patients and healthcare providers when reporting adverse events related to breast implants.
The new total of 2,497 new BII reports that the FDA collected globally dates from November 2018 to October 2019. That’s in addition to the 1,080 BII case reports received from January 2008 through October 2018. The agency attributed the increase to heightened awareness from press, social media and its General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.
The top 10 most common BII symptoms reported to the agency include fatigue (49%), brain fog (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (18%), autoimmune diseases (18 %), inflammation (18%) and/or weight problems (18%). Researchers are investigating these symptoms to better understand their origins and connection to breast implants, the agency said.
The FDA also reported a global increase of 160 new cancer cases related to breast implants since July 2019, for a total of 733 as of Jan. 5, 2020. The number of deaths attributed to these cases rose by 3 to 36.
The FDA began reporting on cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma and a known risk from breast implants, in 2011. The majority of BIA-ALCL cases — 620 — were linked to implants made by Allergan (now part of AbbVie). Forty-seven cases were attributed to an unknown manufacturer, the FDA noted. Of the total number of cases, 496 were related to textured implants, and 209 did not specify the implant surface.
Of the 36 patient deaths reported to the FDA, 15 of the 16 patients for whom the manufacturer of the implant is known were reported to have had an Allergan breast implant at the time of their BIA-ALCL diagnosis. Sixteen deaths were linked to textured implants and 19 reports did not have information on the implant surface.
For device manufacturers, the FDA today announced the qualification of a validated, self-administered questionnaire — the BREAST-Q Reconstruction Module — through the agency’s Medical Device Development Tools program.
“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. 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,” said Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “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.”
