An update on PIP implants

By Andrew McConnell

In 1997, French company Poly Implant Prothèse (PIP) gained CE mark approval to produce breast implants using medical-grade silicone. CE marking is intended to be a key indicator of a product’s compliance with European legislation.

ln March 2010, the French government’s regulatory body for healthcare products — often abbreviated to AFSSAPS — conducted an inspection of PIP’s manufacturing site and discovered the use of an unapproved, industrial-grade silicone in the implants. In response, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a recall notice for all remaining stocks of PIP implants in the UK.

The UK government commissioned an expert investigation group, under the chairmanship of Sir Bruce Keogh (NHS medical director). The report, published in June 2012, concluded that exhaustive testing of PIP implants did not indicate anything that could cause a long-term health threat. However, it was noted that anxiety over possible health risks is a form of health risk in itself and the inferior strength of the implants led to them being considered a substandard product…

Click on the link below to read the rest of the Mills & Reeve briefing.

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