Fresh Safety Recommendation Issued On PIP Breast Implants

Poly Implant Prosthesis (PIP)


The British Association of Aesthetic Plastic Surgeons has issued a new safety recommendation regarding breast implants manufactured by the French firm Poly Implant Prosthesis (PIP). Any women in the UK who have had breast implants manufactured by PIP are being advised to undertake an ultrasound scan in the next six months to ascertain whether there are any weaknesses in their implants. If there are any signs of damage the implants will have to be removed.

On the 31st March 2010 the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a Medical Device Alert in relation to all silicone gel filled breast implants manufactured by PIP, recalling all devices to the UK supplier.

The MHRA acted upon receiving information from the French medical device regulatory authority (AFSSAPS) that they have taken similar steps in France following a recent inspection of the PIP manufacturing plant which revealed that most breast implants manufactured by the company since 2001 have been filled with an unapproved silicone gel.  The AFSSAPS inspection was prompted by an increase in reported incidents (mainly ruptures) involving the implants over the past three years.

The fresh warnings have been given after it emerged that PIP may have dispensed with the protective barrier supposed to be included on the implants which was designed to prevent splitting and leaking on implants being produced from as early as 2005.

Following an investigation by SOFCPRE, the French Society of Reconstructive and Aesthetic Plastic Surgeons, it is clear that the gel being used by PIP was different from the gel which the regulator had authorised for use. In the course of the investigation the manufacturer of the gel was contacted and it became clear that they believed the substance was to be used in manufacturing mattresses. It is unclear how this gel affects human tissue in cases of the implants leaking or rupturing.

It is estimated that 50,000 women in the United Kingdom may have breast implants made by PIP.

PIP has gone into liquidation and it appears they are without insurance.  Following a number of enquiries by women affected by these implant specialist product liability solicitors at Irwin Mitchell have been evaluating the situation. and are alternative routes to compensation for women affected by the latest recall.

If you or someone you know has been affected by these implants, our experts may be able to help. Fill in our online claims form for free legal advice.