aNaLySIS | BREASTIMPlANTS | Saline implants, said to last 12–14 years,


have a semi-permeable silicone elastomer shell with a single valve to the front. Should they rupture, the saline would be absorbed by the body, but the rapid deflation is visible almost immediately.Meanwhile, hydrogel implants are said to offer the safety of saline, but the texture of silicone. like saline, the content of a ruptured shell would be absorbed safely by the body. Many companies, like the French-based


Eurosilicone, chose to specialise in one form. The company offers silicone implants in round and anatomical shapes. like all quality European manufacturers, it has to comply with ISO and EN requirements and CE marks its products in accordance with the EU Medical Device Directive 93/42/EEC. Allergan is the largest breast


implants company in the world. Its breast aesthetics division generated sales of saline and silicone implants totalling $319million in 2010. It sells some 1000 products under a range of names, including Natrelle, Inspira, CUI, BioCell, MicroCell and BioDimensional. The company notes a shift in the North


UK manufacturer — the only one to make silicone implants — is Nagor, which designs, develops and manufactures in FDA-compliant facilities that conform to US quality system requirements (21 CFR 820). They are also manufactured to ISO and EN requirements, and have CE mark certification.


allergan is the


Stem cells for breast augmentation A new technique, stem cell therapy, is beginning to be used in breast augmentation. Under a technique introduced to the market in 2007 by Viennese cosmetic surgeon Dr Karl-Georg Heinrich, stem cells are isolated in a lab from a small amount of liposuction fat


largest breast implants company in the world. Its breast aesthetics


division generated sales of saline and silicone implants totalling


$319million in 2010.


American market, following the 2006 approval of silicone gel breast implants by the Food and Drug Administration (FDA) and Health Canada. That ended a 14-year US and Canadian ban. The majority of breast implants Allergan now sells in that region are silicone gel. The US has long been a key


market and industry influence. The largest


cosmetic surgery may have when something goes wrong with the treatment,’ he says, probably expressing frustrations of an entire industry. Some 20 000 UK people travel abroad for cosmetic surgery every year.


and


reintroduced into the body, injected locally in a given organ or tissue. The procedure is performed


under local anaesthesia. The rejuvenating and regenerative effects are manifested within a few weeks, bringing about improvements in look, vitality, and organ function, it is


claimed. The therapy can be used either alone or in combination with bioidentical hormones (natural hormone therapy).


Worries over cosmetic surgery tourism


To maintain confidence in the sector and prevent its image from suffering, incidences of poor quality


surgery and low-cost procedures need to be exposed and weeded out. The industry takes this duty very seriously, as evidenced by its reaction to the PIP scandal as well as to isolated events, such as the recent case of the 20-year-old British student who travelled to the US for a buttock enhancement. She developed breathing problems shortly after receiving silicone injections at a budget hotel and later died. BAAPS President Fazel


Fatah recommends that women who have gone abroad for breast surgery contact their local clinic or regular GP to find out what type of implant they have been given. A breast scan may even


be necessary. ‘This demonstrates the difficulties 16 ❚ patients who travel abroad for cheaper May 2011 | prime-journal.com


A better regulated sector will buoy the market These cases may, on the surface, appear damaging to the industry, but the key is how the scandal is handled, and how the industry reacts. If anything, the PIP and Rofil cases look likely to increase uptake in the medium term, as the public has been able to observe a mature industry that has a responsible attitude to safe surgery. There is an increasing sense of an


industry becoming better regulated, as evinced by international guidelines for women with PIP implants recommending immediate examination of implant shells and regular checks and magnetic resonance imaging (MRI) scans for women concerned with their surgery. The regulated industry also polices itself


and communicates well. That was seen in January this year, when the US FDA released preliminary findings and analysis regarding recent reports in the scientific community that have suggested a possible association between saline and silicone gel- filled breast implants and the rare cancer, anaplastic large cell lymphoma (AlCl). Allergan reported in its latest 10K (1March


2011) that, based on its review of limited scientific data, the FDA believes that women with breast implants may have a very small but increased risk of developing AlCl in the scar capsule adjacent to the implant. Three in 100 million women per year are diagnosed with AlCl in the breast — including both women with implants and without implants. BAAPS President Fazel Fatah adds:


‘Reputable manufacturers are constantly researching and improving the quality of implants. For the long-term players, it’s not in their interest to [take] short cuts and produce inferior products.’ There can be no doubt that the attention


of the industry and regulators is firmly fixed on safety. With that in mind, users can be assured that a repeat performance of the recent European implant scandal is therefore highly unlikely.


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