Tuesday, 10 December 2019

Ceisteanna (447, 448, 460, 461, 462, 463, 464, 465)

Louise O'Reilly

Ceist:

447. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question Nos. 320, 321, 322, 324 and 325 of 26 November 2019, the reason implants which caused breast implant associated anaplastic large cell lymphoma were used here up until December 2018 in view of the fact that the condition was recognised as a type of ALCL by the World Health Organisation in 2016 [51761/19]

Amharc ar fhreagra

Louise O'Reilly

Ceist:

448. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question Nos. 320, 321, 322, 324 and 325 of 26 November 2019, the reason it took until November and December 2019 for women that were given implants associated with breast implant associated anaplastic large cell lymphoma to be notified of their risk of the condition in view of the fact the condition was recognised as a type of ALCL by the World Health Organisation in 2016 and the use of the implants was ceased here in December 2018 [51762/19]

Amharc ar fhreagra

Louise O'Reilly

Ceist:

460. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question Nos. 320, 321, 322, 324 and 325 of 26 November 2019, if the breast implants which are now known to cause breast implant associated anaplastic large cell lymphoma were centrally purchased; the number in stock when it was withdrawn; if products left in stock have been returned to the company (details supplied) and credited as not fit-for-purpose products; and if they have been destroyed [51881/19]

Amharc ar fhreagra

Louise O'Reilly

Ceist:

461. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question Nos. 320, 321, 322, 324 and 325 of 26 November 2019, if a company (details supplied) or its insurers have met with his Department, the HSE, the Health Products Regulatory Authority or other Departments, offices or statutory bodies in relation to the breast implants which are now known to cause breast implant associated anaplastic large cell lymphoma to discuss their possible ill effect on those that received them [51882/19]

Amharc ar fhreagra

Louise O'Reilly

Ceist:

462. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question Nos. 320, 321, 322, 324 and 325 of 26 November 2019, if he, the HSE or the Health Products Regulatory Authority secured an undertaking from a company (details supplied) that it will fund the removal of implants provided to women in hospitals here which are now known to cause breast implant associated anaplastic large cell lymphoma [51883/19]

Amharc ar fhreagra

Louise O'Reilly

Ceist:

463. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question Nos. 320, 321, 322, 324 and 325 of 26 November 2019, the reason a freephone number was not provided on the correspondence sent to women that received breast implants known to cause breast implant associated anaplastic large cell lymphoma; and the specific training provided to the personnel manning the call lines for the number provided [51884/19]

Amharc ar fhreagra

Louise O'Reilly

Ceist:

464. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question Nos. 320, 321, 322, 324 and 325 of 26 November 2019, the reason the Health Products Regulatory Authority, the HSE or his Department did not as a precautionary measure cease ordering and distributing to participating cancer centres the textured implants of the company (details supplied) in view of the fact there were already significant numbers of reported instances of breast implant associated anaplastic large cell lymphoma attributed to the product [51885/19]

Amharc ar fhreagra

Louise O'Reilly

Ceist:

465. Deputy Louise O'Reilly asked the Minister for Health further to Parliamentary Question Nos. 320, 321, 322, 324 and 325 of 26 November 2019, if women seeking to have the surgical removal of an implant that was provided by the State will have such a procedure provided for in a public or voluntary hospital and that there will not be a cost or charge to the woman in such an event [51886/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

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.