I propose to take Questions Nos. 320 to 322, inclusive, 324 and 325 together.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) is a new and emerging issue and while more specific to highly textured breast implants and tissue expanders, the risk exists for all types of textured breast implants and tissue expanders.
BIA-ALCL is not breast cancer, but a type of non-Hodgkin’s lymphoma – a cancer of the immune system.
BIA- ALCL is a relatively new form of cancer and was given provisional recognition as a type of ALCL by the World Health Organisation (WHO) in 2016. As research has developed, there has been more awareness of this condition over the past number of years. When diagnosed and treated early, it has a very good recovery rate. It has been diagnosed in only a small number of people worldwide.
Most cases of BIA-ALCL have been diagnosed in patients who have implants, or have had tissues expanders manufactured by Allergan, with a specific textured surface called "BIOCELL." These implants and expanders have not been used in Ireland since December 2018.
The Health Products Regulatory Authority (HPRA) has been updating my Department on this matter as further research is published and as evidence continues to emerge at both a European and international level and while the risk of developing BIA-ALCL has been shown to be more common than first thought, it still remains an uncommon condition.
The Health Service Executive (HSE) has decided to communicate publicly on this matter in order 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. My Department has been and continues to work alongside the HSE in this regard.
The 8 national cancer centres are writing directly to their patients who have had breast implants or tissue expanders, including those who received Allergan ‘BIOCELL’ and patients without Allergan ‘BIOCELL’ breast implants/ tissue expanders. The distribution of these letters is an ongoing process, with letters being sent directly by the 8 cancer centres to their patients. As this is an ongoing communication process, I cannot inform the Deputy how many letters have issued.
The letters and the information on the HSE’s website, advise all individuals to be breast aware; describing the signs and symptoms to be aware of and monitor for and what to do if a patient finds a swelling or lump. It is important to note that for patients without any symptoms- no further action is needed apart from routine follow-up.
Dedicated telephone lines have been set up in the 8 cancer centres to provide assurance, encourage women to be breast aware and when necessary allocate clinical review. The phone numbers are included in each patient’s letter.
In December 2018, a French medical device notified body (which evaluates the conformity of products) decided not to renew the CE Certificates for certain breast implants and tissue expanders produced by the company Allergan. The HPRA made information available publicly when the product was withdrawn. The HSE advisory was issued in response to increased understanding of the incidence of the condition based on International studies over the past year.
This current HSE patient advisory programme was initiated in August last based on the evolving understanding of the disease internationally. Since then, my Department has been engaging with a range of national stakeholders, including the HSE, HPRA, clinical representatives and the private hospital sector on this issue to ensure that appropriate action is been taken.