PIP breast implants

The Government disagrees with the Committee on two principal points:

• The Committee concluded that action taken by the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA) to communicate with women with PIP implants after the fraud was detected in March 2010 was inadequate. The  Government has responded that actions by the Department and the Agency were ‘reasonable and proportionate’.
• The Committee welcomed the Government's undertaking that the NHS would remove non-NHS implants in circumstances where the woman was unable to obtain treatment from her original provider, but urged the Government to agree a protocol under which a replacement implant could be inserted in the same operation if that is the wish of the woman, with the support of her clinicians. The Government does not accept this recommendation.       

"We remain broadly supportive of the immediate actions taken by the Government in response to the events of December 2011. Our report was intended to contribute to the Earl Howe and Keogh reviews of Government action taken in respect of the PIP breast implant issue. 

We are pleased to see many of our recommendations accepted by the Government and covered in Earl Howe’s review. We look forward to the final report of Sir Bruce Keogh’s review of the regulation of cosmetic interventions, where we expect more of our concerns will be addressed. 

Although we are disappointed that the Government does not agree with our conclusion that more creative approaches should have been used as soon as the fraud was discovered to raise public awareness of the potential danger to patients (both NHS and private) from the use of PIP breast implants, we welcome Earl Howe’s recommendation that ‘the MHRA should review the processes and governance it uses to ensure that timely and appropriate action is taken in pursuing responses from manufacturers, notified bodies and others, and in ensuring appropriate regulatory actions take place in a timely manner’. Health Committee intends to ask the MHRA to provide the Committee with evidence about how it intends to implement this recommendation.  

We are also disappointed that the Government has not accepted our recommendation that women whose PIP implants are removed by the NHS should be able to have their implants replaced under private arrangements but in the same operation. Women in this position will struggle to understand why an NHS which has undertaken to support them finds it necessary to put them through two operations.  

We are encouraged by the number of participants in the web forum which we set up to monitor the experience of women who have received PIP breast implants.  

We invite more women in this position to join the web forum to share their experience and explain what they think the Government should do. 

The issues raised in our report, and the experiences described on the web forum, also deserve a wider hearing. The Committee will therefore be seeking an early opportunity for a Commons debate once the forum has closed."

Notes to editors

1.    The announcement of the Committee’s report on PIP Breast implants and cosmetic interventions, published on 22 March 2012.

2.    The Health Committee report: PIP Breast Implants and regulation of cosmetic interventions

3.    The Government Response of 14 May to the Health Committee report on PIP Breast implants and regulation of cosmetic interventions

4.    The Health Committee’s web forum on PIP breast implants will run until 31 May 2012. It can be accessed at http://forums.parliament.uk/pip-implants and via the Committee’s homepage at www.parliament.uk/healthcom.

5.    It is estimated that over 40,000 women have received PIP breast implants provided by private clinics or the NHS. The Committee invites all such women to participate in the web forum to give their personal views of their experiences with the implants and their care both before and after the revelations about the safety of PIP implants.

6.    Registered users of the forum are able to post messages without identifying themselves. The forum is pre-moderated to ensure no potentially defamatory comments are made and no private information about named individuals is revealed.

7.    The Committee expects that the information it will gather through the forum will indicate how the PIP issue is affecting women and how the issue is being handled by the NHS and private clinics nationwide.

8.    The Government has set up two reviews: one, led by the Health Minister Earl Howe, which will examine what has happened in the UK in relation to PIP implants; and another, led by the NHS Medical Director, Sir Bruce Keogh, which will look at the wider issues of clinical safety and regulation. The report of Earl Howe’s review was published on 15 May and was announced by the Department of Health. The Health Committee will consider the reports of both reviews: the evidence from the web forum will be instrumental in this consideration.