I propose to take Questions Nos. 447, 448 and 460 to 465, inclusive, together.
The HSE has recently initiated an information and service plan in respect of an uncommon form of cancer called “breast implant associated anaplastic large cell lymphoma” (BIA-ALCL). This condition is not a breast cancer; it is a cancer of the immune system. BIA- ALCL is an uncommon condition and when diagnosed and treated early it has a very good recovery rate. To date, it has been diagnosed in only a small number of people worldwide. Most cases of BIA-ALCL have been in patients with implants or who have had tissues expanders manufactured by Allergan with a surface texture called BIOCELL. These implants and expanders have not been used in Ireland since December 2018.
The HSE has issued letters to public patients who have received a breast implant and placed information on its website, advising all individuals to be breast aware; describing the signs and symptoms to monitor for and what to do if a patient finds a swelling or lump. If patients are concerned that they have a breast lump or swelling, they are advised to make contact with the hospital in which they had their implant surgery or their GP.
There is currently no international evidence to support the removal of the Allergan BIOCELL implants in asymptomatic women at this time and international medical experts recommend that people should not have their implants removed unless the condition has been diagnosed.
Following the European wide recall of Allergan BIOCELL breast implants and tissue expanders in December 2018, the HPRA made this information publicly available via their website where they provided additional background information and advice. Following the commencement of this recall in December 2018, all non-implanted Allergan BIOCELL breast implants and tissue expanders in Ireland were quarantined and returned to the manufacturer.
The HSE advisory programme was initiated in response to an increased understanding of the incidence of the condition and emerging evidence based on international studies over the past year. The advisory aimed to increase general awareness of BIA ALCL, ensure that women in Ireland are fully informed on this issue and are given the appropriate advice and follow up as required.
The HSE's advisory letter to patients included a helpline number, so as to provide assurance, encourage women to be breast aware and when necessary allocate clinical review. The personnel manning the telephone lines received specific training by the HSE.
My Department continues to engage with the HSE, the HPRA and private hospital sector on this issue.