15 May 2012

A report reviewing how the MHRA and the Department of Health handled the concerns raised regarding PIP implants has been published. This report, prepared on behalf of the Department of Health by the health minister Lord Howe, indicates that individual surgeons raised concerns that they were encountering an increased rupture rate in PIP implants back in 2006. These surgeons offered to conduct audits to support their view but instead the MHRA decided to contact the German firm which provided the quality mark for PIP implants to seek assurances. The report concludes that while data gathering and communication could be improved, both the Department of Health and the MHRA acted appropriately both in 2006 and in 2010, when PIP implants were finally banned, given the information available to them.

The BBC article on this report can be found here, and a link to the report itself can be found here.

26 April 2012

An academic paper has come to light indicating that up to one in three women with PIP implants who took part in the study suffered from a rupture, whether they were suffering from the symptoms of rupture or not. Previous research has suggested a rupture rate of 5 per cent. However, doctors have urged caution in reading too much into a single study.

The academic paper is the subject of a newspaper article reported here.

Meanwhile, the EU has passed a resolution supporting more stringent controls of medical devices in the wake of the PIP scandal. Among the planned measures are, a breast implant register, a pre-market authorisation system, product traceability, better coordination when problems arise and more stringent checks.

Further detail can be found here.

16 March 2012

The Medicine and Healthcare products Regulatory Agency (MHRA) has issued advice to surgeons and doctors in the UK that women who had silicone gel implants manufactured Poly Implant Prothèses before 2001 should be treated the same as women who had the implants more recently. Previously it had been thought that only implants put in on 2001 or later contained the potentially harmful silicone gel said to be suitable for mattress filler rather than medical use. However, French medical authorities have shared new evidence with the MRHA indicating that Poly Implant Prothèses potentially used the substandard gel before 2001. It is estimated that this means another 7000 women will now be affected by the PIP implant scandal.

Read the MHRA’s press release on its latest advice here, and a news article on the subject here.

If you are worried about any of the issues discussed within this post do not hesitate to contact the PIP Implant Team directly on 01923 223 324, 0800 731 5821 or at charkness@collinslaw.co.uk.

8 March 2012

The European Commission has ordered the EU’s scientific committee to conduct a detailed investigation into the safety of PIP implants. This decision follows the scientific committee raising concerns during an initial inquiry into the matter.

Read the story here.

If you are worried about any of the issues discussed within this post do not hesitate to contact the PIP Implant Team directly on 01923 223 324, 0800 731 5821 or at charkness@collinslaw.co.uk.