UK authorities review their response to the PIP breast implant crisis

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had previously stated quite categorically that the removal of breast implants from women affected by the Poly Implant Prothese (PIP) scandal was unnecessary.

In the most up-to-date statement on its website, published on 23 December 2011, the MHRA stated as follows:

“Following the announcement in France today, the Medicines and Healthcare products Regulatory Agency (MHRA) is not recommending routine removal of PIP silicone gel breast implants in the UK.

We recognise the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France.

We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence…

In the absence of strong clear evidence to the contrary, we see no reason to alter our current advice that there is no need to routinely remove these PIP breast implants…”

However, the MHRA has since confirmed that “doubts” have emerged about the information which it had received from cosmetic surgeons.  It was on this information that it has based its previous decisions as to how to respond to the crisis surrounding PIP breast implants.

The MHRA had previously understood that rupture rates in the UK were around 1%.  However, anectodal evidence from clinics which used the implants would now suggest that this figure is closer to 8%.

This has spurred the Health Secretary Andrew Lansley to order an urgent inquiry to enable the review of the information provided by private clinics with a view to ascertaining the true rate at which these implants have been failing after implantation in patients.

Speaking to the BBC, Tim Goodacre, a member of the Government-commissioned panel investigating the scandal stated:

“If you believe a device is faulty in your car or any other object you buy you would want to have that replaced on a staged basis…[G]iven the fact there is a degree of uncertainty and a lack of knowledge, we’re recommending all implants come out.”

While this review is welcome, the UK authorities have not been as admirably proactive as their French counterparts, with the latter having recommended that all affected women should have their implants removed and confirming that the French health system would pick up the tab.

As yet there has been no formal change in the position being adopted by the Irish Medicines Board (IMB) which last made a statement on 23 December 2011, in which it again restated its advice that there is no current evidence of health risks associated with PIP implants.

Irish women affected by this scandal will no doubt await with interest whether these recent developments in the UK will prompt the IMB to vary its position.

John McCarthy presently acts for clients nationwide in pursuing compensation for the injuries which they have sustained from defective medical devices.

If you have been affected by the PIP recall or you believe that you have been the victim of negligent cosmetic surgery and you would like to arrange a free initial consultation with John, feel free to call him on 023 883 3348 or email him at john@mccarthy.ie to discuss your case in complete confidence and without commitment.

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John specialises in personal injury and medical negligence claims. His practice focuses on high value compensation cases. He has extensive experience in this area of litigation for over 10 years. Read more