Regulatory Focus™ > News Articles > UK Publishes Review of PIP Breast Implant Scandal, Calls for Improvements

UK Publishes Review of PIP Breast Implant Scandal, Calls for Improvements

Posted 14 May 2012 | By Alexander Gaffney, RAC 

The UK's Department of Health (DOH) has released the result of a review into the Poly Implant Prothese (PIP) Scandal, finding the Medicines and Healthcare product Regulatory Agency (MHRA) to have "room for improvement" and in need of learning "serious lessons."

The report, undertaken by Health Minister Lord Howe, was done in response to the failings of breast implant products manufactured by PIP, whose former executives have since been arrested by French investigators for allegedly using industrial-grade silicone in their implant products.

An inquiry into the regulation of PIP's product in the UK was launched by Health Secretary Andrew Lansley in January 2012 after MHRA was bombarded with withering criticism, including from the medical journal The Lancet.

The released report is the result of a separate review by Howe, and makes a number of recommendations to MHRA.

Those recommendations include the review and development of its communications capacity to better communicate to patients regarding defective devices, the ability to gather evidence from a more diverse population of sources using "sophisticated and rich sources of data," and the ability to routinely review the sum total of the information about specific higher-risk devices" to identify any problems rapidly.

While Lord Howe insisted this was a case of "deliberate fraud" beyond the exclusive scope of regulatory authorities, he admitted "serious lessons must be learned from this scandal."

"It is clear that problems occurred that weren't reported to the regulator," said Howe in a press statement. "A vigilance system is only as good as the information that is reported to it. More needs to be done to ensure that problems with medical devices are reported, so problems can be identified and action taken to address them."

Howe's report also calls for additional coordination between EU regulatory authorities to ensure the early detection and removal of unsafe medical devices.

"The Government will work to ensure that the ongoing revision of the European regulation of devices ensures the system works robustly and that information sharing across international boundaries is made much easier," said DOH in a statement.

Lansley's report into the PIP scandal, being investigated by National Health Service Director Sir Bruce Keough, is still under development.

Read more:

DOH - Review into PiP implant scandal published

Regulatory Focus - PIP Executive Arrested in France, Could be Charged With Manslaughter

Regulatory Focus - Lansley Seeks Additional Data Collection, Looks to Improve UK & EMA Regulations

Regulatory Focus - Lancet: US FDA's Approach to Silicone-Gel Regulation a Model for Others

Regulatory Focus - MHRA Fires Back at The Lancet, Says Critics Lack "Clear Analysis of the Facts"

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