French Implants Test 'inconclusive'
Implants ‘Sweat’ Irritant Silicone Even Without Rupture
29 September 2010 (Last updated: 26 Mar 2019 14:21)
London – 29 September, 2010 – As new test results from the French Competent Authority (AFSSAPS) into controversial PIP breast implants cannot entirely rule out genotoxicity (DNA cell disruption), the British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk), re-issues safety recommendations for women in the UK who have PIPs. In line with AFSSAPS, the BAAPS, the not-for-profit organisation established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit, recommends all women who have these implants undergo an ultrasound within the next six months to determine rupture or weakening. Should this be encountered even in one implant, the advice is unequivocal: both should be removed.
The findings of the study include:
The rate of rupture is higher than with other implants, in particular relating to the first five years
Clinical observations indicate a ‘sweating’ aspect, even without rupture
Cases of adenomegaly (enlargement of lymph glands due to accumulation of silicone) were noted even without rupture of the implants
The gel was in fact silicone but not of the level of quality required for breast implants
Tests of mechanical strength revealed a higher-than-average fragility of the shells
No acute toxicity (cytotoxicity) effect on tissue but intradermal tests show an irritant behaviour of the PIP gel not found in other implants. Contact with the gel caused by rupture or leakage can cause inflammatory reactions in patients
Tests for genotoxicity (effect of the gel on DNA of cells) were carried out both in vitro and in vivo – on mice – and the latter indicated a possible disruption of cell division. This does not allow for a conclusive result and further extensive testing will need to take place over the next 3-4 months. Final conclusions are expected in 2011.
Tests also demonstrated a significant difference in the quality from one implant to another, so not all have the same levels of weakness
Despite proving unpopular with the majority of BAAPS members, it has been estimated that roughly 50,000 women in the UK could have these breast implants, as they were the product of choice for large chains and commercial clinics because of their low cost.
According to consultant plastic surgeon and former BAAPS President Nigel Mercer;
“The BAAPS continues to recommend that women who’ve undergone breast augmentation contact their surgeons to find out what type of implant was used. If it’s PIP they should have an ultrasound in the next six months to establish whether there is any weakening or rupture. Removal of both implants is recommended in these cases.”
According to consultant plastic surgeon and former BAAPS President Douglas McGeorge;
“In line with AFSSAPS, we recommend that concerned women discuss their options with their surgeon, including possible removal even without deterioration of the implant - if this should be right for their personal situation or preferences.”
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
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