12 reports of potential ‘breast implant illness’ received by HPRA

The Health Products Regulatory Authority (HPRA) has received 34 incident reports related to breast implants and three incident reports related to breast tissue expanders since January 2017, a spokesperson for the Authority has told the Medical Independent (MI).  These figures include 12 reports which may potentially relate to breast implant illness (BII).

“Some health researchers and patients have used the term ‘BII’ to refer to systemic symptoms such as joint pain, rashes, memory loss, ‘brain fog’ or other symptoms,” the spokesperson told MI.

“These symptoms, and what causes them, are not well understood at this time. There is ongoing research to try to understand these symptoms and their origin. The HPRA encourages reporting of any concerns in relation to breast implants, by patients or healthcare professionals, via our online portal, details of which can be found on our website.”

However, the HPRA said it has not received any reports of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) occurring in individuals in Ireland.

The risk of BIA-ALCL in specific individuals appears to vary, depending on the degree of surface texturing present on breast implants from different manufacturers, according to the Authority.

In reports made to a number of medical device regulators worldwide, the majority of cases of BIA-ALCL have been seen in implants manufactured by Allergan with an implant surface called BIOCELL. A recent journal article estimated there is one case of BIA-ALCL for every 3,345 of these specific implants used.

“Allergan implants with a BIOCELL surface had been commonly used in Ireland prior to a European recall of these implants in December 2018,” according to the HPRA.