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Implants - Regulation of Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA), News & Updates

BBC Radio 4 report: PiP implants, the cosmetic industry and criticism of the European regulatory system

In this BBC Radio 4 report aired on 6th September 2012, Melanie Abbott reports on the aftermath of the PiP breast implant scandal, and reveals how two leading cosmetic surgery companies have blamed the European regulatory system for the scandal.

PiP implants sold by a French company were found to contain industrial grade silicone filler and to be more likely to rupture.  These implants were approved by a German Notifying Body and allowed to be sold throughout Europe and accepted by the UK’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), for sale in the UK.

A government review into the defective PiP breast implant deemed the MHRA to have acted appropriately when investigating the implants.  However, it found room for improvement in the way the MHRA monitors and gathers information about implants.

The defective PiP implants have cost the UK National Health Service £1.2 million in England alone in removal surgery.  Some private firms have been criticised for refusing to remove the implants and for using the implants in the first place.

Harley Medical Group and Transform are blaming failures in the European regulatory systemfor not spotting the defective implants.  The implants were CE marked which is supposed to verify that they are safe and effective.  A spokesperson from the Harley Group says they are trying their best to help their patients and discharge their duty of care.  They have operated on many patients without charging them but the financial costs to their business have been in the order of hundreds of thousands of pounds.

Transform think that more powers should be given to the MHRA, such as the levy of a tax on implant manufacturers which should be put into a fund to pay out in similar cases of device failure.  The devices should be checked to ensure they conform to regulations.  It has also called for a compulsory national register of breast implants.

The cosmetic surgery industry is now undergoing a review following the breast implant scandal.  The review is being led by NHS Medical Director, Sir Bruce Keogh, and the findings are to be published in March 2013.

To read more and listen to programme, click on image below:

Bruce Keogh, NHS Medical Director



2 thoughts on “BBC Radio 4 report: PiP implants, the cosmetic industry and criticism of the European regulatory system

  1. Well done! Brilliant additions from around the world. IH.

    Posted by I H | September 7, 2012, 10:13 pm
  2. Agree with the call for levy on implant manufacturers and there should be a national database for ALL implants not just breast implants. But I don’t know whether this would solve the issue because if the database is not carefully done, and doctors still don’t report complications, then it would still not give an accurate picture of what’s happening. Meanwhile women are being harmed while doctors carry on implanting this stuff and the regulatory authorities continue dithering.

    Posted by tvtinfo | September 8, 2012, 8:11 am

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