PIP Breast Implants

Monday 18th June 2012 Written Statements

[The Secretary of State for Health (Mr Andrew Lansley)]

The Department is today publishing the final report of the expert group chaired by Sir Bruce Keogh, the NHS medical director, on the silicone breast implants manufactured by the firm Poly Implant Prothese (PIP). I am very grateful to Sir Bruce and to all the members of the expert group for the expertise and commitment they have brought to this task.

The expert group had available considerably more information than when they published their interim report in January. The new information includes the results of a major collection of data on explantation of PIP and other breast implants over the period 2001-11, as well as chemical analyses of a representative sample of batches of PIP and other implants. This makes it possible for the first time to make a valid comparison of the rates of rupture between PIP and other brands of breast implant, as well as to comment on the clinical significance of ruptures and silicone bleeds.

The group have concluded that:

rigorous chemical and toxicological analyses of a wide variety of PIP implants have not shown any evidence of significant risk to human health;

PIP implants are significantly more likely to rupture or leak silicone than other implants;

in a proportion of cases, failure of the PIP implant results in local reactions but these are readily detected by outward clinical signs—“silent” ruptures (ruptures which came to light only on explantation) are not generally associated with these local reactions; and

there remains no evidence of any longer-term, systemic adverse effects from breast silicone implants.

The group have reiterated and amplified their earlier advice that:

all providers of breast implant surgery should contact any women who have or may have PIP implants—if they have not already done so—and offer them a specialist consultation and any appropriate investigation to determine if the implants are still intact;

if the original provider is unable or unwilling to do this, a woman should seek referral through her GP to an appropriate specialist;

if there is any sign of rupture, she should be offered an explantation;

if the implants still appear to be intact she should be offered the opportunity to discuss with her specialist the best way forward, taking into account the factors listed in the report;

if in the light of this advice a woman decides with her doctor that, in her individual circumstances, she wishes to have her implants removed her healthcare provider should support her in carrying out this surgery; and

if a woman decides not to seek early explantation, she should be offered annual follow up in line with the advice issued by the specialist surgical associations in January 2012. Women who make this choice should be encouraged to consult their doctor if they notice any signs of tenderness or pain, or swollen lymph glands in or around their breasts or armpits, which may indicate a rupture. At the first signs of rupture, they should be offered removal of the implants.

We recognise that this remains a very worrying time for all women who have received PIP implants. This report should give them some reassurance that they will not suffer long-term ill effects from their implants and, in particular, that the silicone gel used in PIP implants is not in itself harmful. Nevertheless, our advice remains that if any woman with PIP implants remains concerned she should seek a consultation with her specialist and discuss, in the light of these findings, the best way forward for her. As we made clear in January, the NHS is ready to help and support women in these circumstances. If the implant was originally provided on the NHS, the NHS will remove and replace the implants if a woman and her doctor decide that this is the right course. If the original operation was carried out in the private sector, and the private provider is unwilling or unable to help, the NHS will remove (but not normally replace) the implants.

The report has been placed in the Library. Copies are available to hon. Members from the Vote Office and to noble Lords from the Printed paper Office.