Defective implant death prompts review
UK Surgeons Reiterate Advice
London – 3 December, 2011 - A 53-year-old woman who had controversial PIP implants died last week in France from malignant lymphoma, developed in the breast’s capsular scar tissue, prompting a review of PIP explantation policy (removal of implant) by French regulatory authority AFSSAPS. It is thought that up to 50,000 women in the UK may have these defective devices, filled with a silicone meant for industrial rather than medical use. Tests in France showed there is no genotoxicity effect in the gel but AFSSAPS is investigating further whether other aspects, such as the irritant quality of the gel, could be an aggravating factor in this case. Today, the British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk) reiterates previous recommendations and urges UK patients not to worry.
The company producing Poly Implants Protheses (PIP), now defunct, used non-medical grade silicone believed by the manufacturers to be made for mattresses, and dispensed with the protective shells of the implant. This meant these low-cost devices were more likely to split – 10% of them within the first year (on average, implants should last 10 years). PIP sold over 300,000 implants around the world over the last 12 years, and at one time the firm was the world’s third-largest manufacturer of implants with 90% of their production going to Britain and Spain.
According to consultant plastic surgeon and BAAPS President Fazel Fatah;
“It is important to remember that the number of breast implant patients globally is considered to be higher than 10 million, yet these tumours are extremely rare. The risk of death is just 1 in 2 Million from it and cure available for 94% of sufferers, so women should continue to feel that their implants are safe. The cause is still unknown and is probably the result of a number of rare different factors, partly genetic, coming together in the afflicted women. In relation to PIPs we continue to reiterate our advice to UK patients in line with the French authorities: if you have, or suspect you have these implants, you should have a scan every six months. If there is any rupture or weakening, have both implants removed.”
Although a possible association in women with breast implants and Anaplastic Large Cell Lymphoma (ALCL) has been observed in a small number of reported cases worldwide, a direct link with the implants has not been established. Fazel Fatah adds;
“ALCL is normally slow to progress and not aggressive, with a good likelihood of recovery. Our members have been made aware of this extremely rare association for a while to make sure the right steps are taken if the condition is suspected in a woman with breast implant. Women with breast implants can be reassured of the very nature of the rare association and there is no need to remove their implants unless they develop sudden unexplained changes or swelling. Any further advice specific to PIPs will depend on the results of the new investigation carried out by the French Authorities.”
About the BAAPS
The British Association of Aesthetic Plastic Surgeons (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 web site, and further materials can be posted to members of the public seeking specialised information. Follow BAAPS on Twitter:www.twitter.com/BAAPSMedia or join us on Facebook:www.facebook.com/BritishAssociationofAestheticPlasticSurgeons
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