Latest developments on PIP Implants controversy
Studies to be carried out in UK following delays– samples impounded in France
09 June 2010 (Last updated: 26 Mar 2019 14:17)
London – 9 July, 2010 – The British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk), welcomes today the decision by the Medicine and Healthcare Regulatory Agency (MHRA) to conduct their own toxicology studies into the gel within controversial PIP implants - in view of further delays from the French authorities. The BAAPS, the not-for-profit organisation established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit, have previously issued a call for all women who have this type of implants to undergo an ultrasound scan in the next six months, to determine whether there is any rupture or weakening.
The removal of funding from the Breast Implant Registry some years ago means that it is impossible to know exactly how many women in the UK have these implants, which were not generally popular with BAAPS members, but it has been estimated that up to 50,000 women in the UK could have these low-cost breast implants. Results of biocompatibility tests were expected this month from France, but due to criminal charges, the samples were impounded by the Court and studies were therefore delayed. The French Competent Authority (AFSSAPS) advises that results are now expected in September, spurring the MHRA into conducting their own tests, which should be completed in mid-August.
According to consultant plastic surgeon and BAAPS President Nigel Mercer:
“We would like to praise the MHRA for their proactive response in conducting their own tests in this country, so results can be obtained more quickly. Understandably, British women are very concerned and the sooner they can be fully informed the better.”
The study by SOFCPRE found that the company making PIP implants, which has now gone into administration, not only dispensed with the protective barrier from 2005 but was also using a gel (within the implant) which had not been the one tested originally and CE marked. To determine how the altered version might react with the human body, SOFCPRE contacted the manufacturer of the gel, which was supplied to PIP for any studies – however none were available.
Nigel Mercer adds:
"Whilst tests are conducted into the gel, BAAPS recommendation remains that women who've undergone breast augmentation find out what type of implant was used. If it's PIP they should have an ultrasound to establish whether there is any rupture or weakening. Removal is only recommended in these cases, but if there is one ruptured implant, the one on the other side should be taken out as well, as a precautionary measure."
Surgeons who remove any ruptured PIP implants are advised to contact the MHRA.
ENDS
The BAAPS (www.baaps.org.uk), based at the Royal College of Surgeons, is a not-for-profit organisation, established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit. Members undergo thorough background screening before they can join. Information about specific procedures and surgeons’ contact details can be found on the website, or by contacting their office at 020 7430 1840. Further materials can be posted to members of the public seeking specialised information. BAAPS is also on Twitter: www.twitter.com/BAAPSMedia and Facebook: www.facebook.com/BritishAssociationofAestheticPlasticSurgeons
For all media enquiries, please contact pr@baaps.org.uk
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