Breast Implants - Implants filled with silicone gel recalled by manufacturer PIP
Alert
The Medicines and Healthcare products Regulatory Agency (MHRA), issued an alert on 31st March 2010 recalling all silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). The alert stated that the implants should not be implanted, and all implants should be returned to the distributor.
Problem
The problem was advised to the MHRA by the French medical device regulatory authority (AFSSAPS) on 30th March 2010. The French authority has withdrawn the marketing, distribution, export and use of these implants. They found that the composition of the implants is different from that approved to make its use legal, and further tests are being carried out. At this stage there is no evidence that the gel is harmful. Once information as to the safety of these implants is known the MHRA will issue advice on management.
Manufacturer
The breast implants affected by this problem are: silicone gel filled implants manufactured by PIP between 2001 and 2009 with model numbers: IMGHC-TX, IMGHC-MX, IMGHC-LS.
What you need to do
If you are concerned about your PIP implants or need advice as to the type of implants you have, then contact the surgeon who implanted them, your GP, or the centre where you had them implanted.
Further Information
The MHRA have a useful website containing an information booklet on breast implants: www.mhra.gov.uk/mhra/breastimplants.
The British Association of Aesthetic Plastic Surgeons (BAAPS) has stated that there is no evidence that the gel [they] contain is harmful or that the implants will leak into the body. They endorse the recommendation of the MHRA to seek advice from the implanting surgeon. www.baaps.org.uk.
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