| BREASTIMPlANTS | aNaLySIS
Last year in the UK, breast augmentation
showed an impressive growth of over 10%, says the Britishassociation ofaesthetic Plastic Surgeons.
One decade ago, the UK — and then
France — banned hydrogel implants (while France concurrently lifted its ban on silicone implants). And we also witnessed the soya oil-filled Trilucent cases, for which criminal negligence hearings in Europe heard that materials used in the implants, manufactured by Swiss company lipoMatrix (renamed AEI), had not been properly tested, leading to some instances of rupture. These incidences prompted French and
UK authorities — the the prime movers on the European regulatory scene for implants — to persuade the EU to classify breast implants high-risk (class III) medical devices, and thereby subject to a notified body review of the design dossier. Since then, it has gone quiet on the breast
implant scandal front. Until one year ago, that is. But how have the latest incidents affected uptake? Confidence has actually remained high.
last year in the UK, for instance, breast augmentation showed an impressive growth of over 10%, according to the British Association of Aesthetic Plastic Surgeons (BAAPS). Its members carried out over 9400 procedures in 2010. ‘The industry was not hit noticeably by the economic recession and confidence
remains high,’ said a BAAPS spokeswoman. As a rule, breast augmentation procedures tend to rise by 10–12% every year in the UK. Growth was, however, much lower in 2009 — the year before the PIP scandal broke. This was likely a result of caution as the economic problems took hold. It remains the most popular cosmetic surgery procedure in the UK. ‘In many ways, the PIP scandal was an
aberration,’ BAAPS President Fazel Fatah told PRIME. ‘The industry standard for silicone implants is very high, and the vast majority of companies adhere rigidly to medical grade silicone.’
Worldwide procedures The same is true worldwide. Globally, breast augmentation is the leading cosmetic surgery procedure. In the 2009 worldwide survey conducted by International Society of Aesthetic and Plastic Surgery (ISAPS), 1.45 million breast augmentation procedures were performed by board-certified plastic surgeons that year. China leads with 222 000 procedures,
followed by the US with 205 000 and Brazil with 172 000; India and Mexico also perform over 100 000 procedures every year. Japan, South Korea, Turkey, Germany
and Italy, in descending order of importance, complete the leading ten nations.
Product range The market offering consists of smooth or textured implant shells, filled with silicone, saline or hydrogel. The textured surface was introduced in response to the contention that it would reduce capsular contracture, which occurs when the scar or capsule around the implant tightens, squeezing the implant, and causing the breast to harden. However, there has been no solid evidence to support this theory. The life of a silicone-gel implant averages
18 years. Next year, the product will have been in commercial use for 50 years. Its soft and pliable texture allows for natural movement. There have been worries over silicone leakage, but no studies have provided evidence to suggest that silicone implants are associated with an increased incidence of breast cancer (see below) or connective tissue diseases. Cohesive gel implants have a durable
silicone shell comprising a number of layers to prevent leakage, and the gel filler has a thick, cohesive consistency, meaning that a rupture would not cause the silicone to spill out. They have a shape memory, reducing the risk that the shell will ripple or fold.
prime-journal.com | May2011 ❚ 15
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