Statement from the Chief Medical Officer in relation to PIP Breast Implants
I would like to update interested parties on the current position regarding the PIP Breast Implant issue. As Chief Medical Officer my priority at all times has been to ensure the safety and quality of services for the women concerned and I fully appreciate the anxiety and concern which this issue has generated.
The Department’s and the IMB’s advice to women – which is based on the available scientific evidence – remains consistent that;
- there is no evidence of increased risk of cancer for women with this implant;
- the risk of rupture is within expected norms
- routine explantation (removal) is not recommended;
- and, anyone with a concern about their breast implants should discuss the matter with their GP or surgeon.
The Department and the IMB continue to monitor the emerging scientific research evidence worldwide and will continue to advise based on this evidence.
Since early 2012, on the basis of information made available to me by recipients of PIP implants and contact from representatives of the women concerned, I became aware that women were finding it difficult to receive appropriate follow-up care through their service providers. For that reason, I met with each of the three providers concerned.
In the case of two of the providers it was shown that my expectations that all women would receive professional and appropriate aftercare, have been reasonable in that they have largely been met by these providers without incurring costs to the State and without excessive delay for the women concerned.
However, the third provider’s response has been unsatisfactory, both in terms of its delay in responding to initial correspondence from the Irish Medicines Board (IMB) (instructing all providers to contact their clients about emerging information regarding the quality of implant filling used by the PIP company) and difficulties experienced by patients in accessing their clinical information and provision of appropriate clinical follow-up. Over the course of the last number of weeks, I have had very serious discussions with this provider to ensure a better quality of response and clinical care for the women concerned. During these discussions, I have continuously emphasised the Department’s belief that the company has an obligation to discharge its duties to its clients as the other providers have done.
I have now been advised by the relevant provider that:
- It recognises the shortfall in the service it has provided to date,
- Accepts that it has a duty of care to the women concerned and is fully dedicated to helping its PIP patients as much as it can.
- It is now developing a new care plan to provide for an early surgical consultation for all women who have received PIP breast implants.
- It will offer an early face to face consultation with a surgeon with the option of breast implant removal and
- It will arrange for appropriate surgical treatment where the attending surgeon considers it necessary.
While the proposed care plan is to be welcomed as an improvement on the service offered to date, I must stress that significant detail remains to be clarified and the Department is continuing to discuss the matter with the provider. I will follow up with this provider to ensure that it comes through on its commitment. As always, my concern is that the women affected receive the service they require and that secondly, the providers – not the taxpayer – meet the costs that arise.
Finally, it must be reiterated that the resolution of the implants issue has to be between provider and client and an appropriate solution found between the parties; the Department will continue to encourage all parties to reach an acceptable solution for all concerned.