There have been 325 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the EU, of which 288 are confirmed cases, according to the European Commission (EC). The statistics were supplied to the Medical Independent (MI) by the EC on 27 February.
As reported in the last issue of MI, BIA-ALCL has been identified in Ireland. However, the Health Products Regulatory Authority (HPRA) said no figures were being released due to the low number of case(s) confirmed to date.
According to the HSE, BIA-ALCL is “rare, with a low risk to people with breast implants”.
Internationally, most cases have been in patients with implants or tissue expanders manufactured by Allergan, with a surface texture called BIOCELL. These devices were commonly used in Ireland prior to a European recall in December 2018.
The EC’s scientific committee on health, environmental and emerging risks (SCHEER) is developing a scientific opinion on the safety of breast implants in relation to ALCL.
“Given the increase in confirmed and unconfirmed reports of BIA-ALCL, we may be confronted with an emerging health risk and SCHEER should provide an opinion on the safety of breast implants in relation to anaplastic large cell lymphoma,” according to a SCHEER document. The deadline for its opinion paper is 31 August next.
A HPRA spokesperson said it will continue to work closely with the EC “and, as a matter of priority, will ensure the introduction of evidence-based actions as appropriate”.
Last October, the HSE published an information notice on its website on BIA-ALCL and stated that letters would be sent to patients providing guidance on the issue.
According to a HSE spokesperson, hospitals at which patients received implants since 1997 were asked to generate and check a breast implant patient list and issue patient letters.
“Dedicated telephone lines were opened to provide assurance and appropriate onward advice/management to all patients who received letters. Each letter detailed the telephone number.”
The HSE “does not have authority” to either direct or collate any actions to, or from, private hospitals.