aNaLySIS | BREASTIMPlANTS |


shows no sIgn of slowIng


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ASHLEY YEO, Principal Analyst, Informa Business Information


email ashley.yeo@ informa.com


14 ❚ May 2011 | prime-journal.com


verONe year agO,ON 1 april 2010, the French healthcare products safety regulator, afssaps (agence Française de Sécurité Sanitaire des


Produits de Santé), ordered a ban on the use of silicone gel-filled implants made by the Poly Implant Prothèse (PIP) company, after reports that an unauthorised filler was being used. This was discovered after some of the implants had ruptured. The gel, since banned at European


Union (EU) level, had been used by PIP for 9 years, and is currently in some 6% of the half a million French women who are recipients of breast implants. Their low cost made them popular with the larger domestic chains and commercial clinics, but now all PIP implantees have been advised to undergo medical checks. Meanwhile, Afssaps ordered genotoxicity


and chemical safety tests. They found no acute toxicity (cytotoxicity) effect on tissue. However, tests for genotoxicity (effect of the gel on DNA of cells) did not give conclusive results, and further extensive testing was requested. Fast-forward 10 months to February 2011,


and another company, Dutch manufacturer Rofil, also came under the spotlight as a


InterestIn breast Implant surgery


Investigations into faulty silicone-filled breast implants threw the breast implant industry into disarray last year. Not since the early 2000s and scandals over soya-filled implants has the industry been in the media spotlight so intensely


result of its association with PIP and the suspicion that its branded hydrogel implants may also contain the illegal filler. The Dutch healthcare inspectorate


(Inspectie voor de Gezondheidszorg; IGZ) issued a warning about Rofil in April 2010, but not all countries reacted quickly. It has since emerged that rebranded PIP implants have been used widely in health tourism clinics around the world. The global extent is unknown, but by way of example, 5000 British women travel abroad for breast augmentation every year. So much for the latest scandal, the effects


of which are yet to play out fully in international markets. But it is worth noting that the regulators’ warnings came quickly, for the most part, with the possible exception of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and the case centres on a defined number of European manufacturers. Although the effects of the PIP affair


have been felt in many parts of the world, touching Belgium, Spain, Italy, Portugal, the Czech Republic, Australia and South America, as well as those listed previously (although Brazil and Argentina reported no failures), the scare seems have scored fewer mainstream news column inches than those of the early 2000s.


LEADING


10 NATIONS IN THE ISAPS


GLOBAL SURVEY FOR BREAST


AUGMENTATION PROCEDURES


1 China 2 US


3 Brazil 4 India 5 Mexico 6 Japan


7 South Korea 8 Turkey 9 Germany 10 Italy


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