Check out our PIP Breast Implants Timeline for a summary of the Key Events leading up to the PIP crisis…and some issues which are still ongoing!
- 1997 – PIP gain CE Mark approval from Notified Body TUV Rheinland to produce implants using supposedly medical-grade silicone
- 2000 – Regulatory responsibility for PIP silicone implants passes between TUV and the national regulator: Agence Francaise de Securite Sanitaire des Produits de Sante
- March 2000 – The FDA refuse to approve PIP’s saline implants range
- June 2000 – FDA warns of 11 “good manufacturing deviations” at the PIP plant
- Dec 2000 – PIP involved in minor scandal over Hydrogel implants safety. The product is recalled but women not advised to have checks or compulsory removals
- 2001 – The year it was originally believed PIP began fraudulently using industrial-grade silicone. The later DoH report of 15th March admits this could have begun at any time!
- 2006-2007 – Surgeons Brook Berry and Ruth Waters both write articles for The British Journal of Plastic Surgeons, independently alerting the industry to their concerns over PIP implants based on experiences with patients. Little notice is taken
- 2009 – increasing numbers of complaints from medical professionals about PIP implants (particularly in France). The MHRA (UK regulatory agency) warned by Hugh James solicitors of a potential crisis following unusual numbers of filed complaints
- End of 2009 – PIP goes into liquidisation. Unwilling or unable to pay court awards of compensation for all these filed complaints, PIP go into administration then bankruptcy.
- Spring 2010 – former PIP chief engineer reports his concerns about skimping on production processes to the French authorities. Mentions the concept of a ‘higher end’ range using the approved medical-grade silicone and a cheaper ‘budget’ range using non-approved industrial substances
- 2010 – PIP implants banned. First in France, then the UK MHRA follows suit advising doctors against using
- Oct 2010 – MHRA admits to ongoing testing on PIP implants but says no link to cancer
- April 2011 – French regulators claim no evidence of increased cancer risk or toxicity in PIP implants
- 23rd December 2011 – news breaks that France describe PIP implants as ‘faulty’ and recommend their ‘precautionary’ removal. UK accused of playing down the problem with a “Keep Calm and Carry On” message insisting there is no need for removals and no evidence of any health issues or increased rupture rate
- Jan 2012 – The UK Government acknowledge that Anxiety caused by PIP implants is sufficient reason to have them removed. NHS-provided PIP implants to be replaced for free: private clinics urged to offer the same service. The MHRA still maintain no definite health risks linked to PIP implants but BAAPS (British Association of Aesthetic Plastic Surgeons) agree with France that the risks and symptoms are too great to leave these implants insitu
- 15th March 2012 – the UK Government admits that an extra 7000 women than previously thought are likely to have PIPs as the previous line of thought that PIP only began using substandard silicone post-2001 was incorrect. This takes the UK total up to 47,000
- March 2012 – the NHS agree to perform removals (but not replacements) for private patients in cases of ‘medical need’, including distress. If replacement is required, this will involve two separate operations
- March 2012 – The High Court advise solicitors to join together to produce a Group Litigation representing all PIPettes filing Personal Injury and Clinical Negligence claims relating to PIP implants
From this sequence of events, it is pretty clear that problems with PIP as a company in general were raised long before the current “PIPgate” crisis.