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  1. #1
    Thailand Expat HermantheGerman's Avatar
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    The Boom & Bust trend

    Just want to warn you guys ! Be careful what you are sucking on and don't over do it.



    The breast implants scandal affects us too

    I am one of thousands of women who had reconstructive surgery after treatment for cancer although I am one of the lucky ones

    To read some of our tabloid newspapers which are not adverse to showing the odd bare breast you might be seduced into thinking that the still-unfolding scandal of faulty breast implants made by the French firm Poly Implant Prothese (PIP) was just about vain women seeking Barbie Doll-style boob jobs. Serve them right if their treatment at dodgy cosmetic clinics all goes horribly wrong. Why should the NHS have to pay for them to have faulty implants removed?
    So much for sisterhood. Or indeed for the many women, including me, who have had breast reconstruction using implants after surgery to treat breast cancer.
    Four years ago in the blurry haze following my diagnosis I had to make a swift decision about whether to have a breast reconstruction at the same time as my mastectomy. I decided to go ahead and was told that, because of my slim build, my only option was a procedure involving a silicone implant. The last thing on my mind as I was led down to the operating theatre was to check which company had made the implant, let alone in which country.
    When the scare about the PIP implants erupted just before Christmas, I was one of the lucky ones: I already knew that the alien beast nestling under my pectoral major muscle is not made by PIP. My knowledge had nothing to do with any incisive questioning on my part, but because my consultant sent me all the details in a letter prior to my operation.
    But many other women who have been treated for breast cancer and fitted with PIP implants before the 2010 ban on their use in the UK may not have had such reassurances. Indeed, treatment solely on the NHS rarely comes with such information.
    Of the suspected implants fitted into more than 40,000 UK patients in 2000-2010, the Department of Health says that 2,000 to 3,000 were provided by the NHS 5-7% of the total which by implication means they were for breast reconstruction, as the NHS does not perform cosmetic sugery.
    Some commentators have conveniently used this to emphasise that the overwhelming majority of implant operations in the UK involve cosmetic procedures entered into voluntarily and privately. So does that mean that the minority do not count? Or indeed that any of these women are less deserving of concern?
    Emma Pennery, clinical director of the Breast Cancer Care charity (BCC), says she believes the impact of the scandal for women with breast cancer has been buried as a result of the media using it as a stick with which to beat women opting for aesthetic enhancement. "If there are 2,000 to 3,000 women affected in the UK then that is not an insignificant number. These are women who will have to make decisions about having their implants removed. And it's more complicated than in a case of cosmetic surgery when women would still have their original breast as well as the implant allowing an 'envelope' in which to place the replacement implant. After a mastectomy there may be little or even no tissue, which can be more restrictive for the surgeon."
    Another issue is whether the French scandal could undermine women's confidence in implants generally. Around 50,000 women in the UK are diagnosed with breast cancer every year. The most recent All Breast Cancer Report, using data from 2007, reported that 43% of women diagnosed had surgery to remove their breasts with 11% opting for immediate reconstruction while a national audit for the Royal College of Surgeons put the latter figure higher at 21%. Medical evidence suggests that women faced with the trauma of losing a breast will cope better if they have a reconstructed one. An alternative to implants is to use skin, fat and sometimes muscle taken from another part of the body to make a new breast, but this type of operation is longer and more complex than using an implant.
    Today, an expert advisory group headed by Professor Sir Bruce Keogh, the NHS's medical director, is due to publish its findings on how the UK authorities can avert a similar scandal in the future. It is expected to recommend a new register to ensure that reliable and consistent data is logged by all private clinics and providers. Unless pressure builds for change and the women who are the victims of misconduct stop being seen as in the wrong, this new register will not be enough.
    The breast implants scandal affects us too | World news | The Guardian


    Exclusive - EU medicines head urges tougher implant rules

    (Reuters) - The new head of Europe's drugs watchdog said on Friday there was an acute need to tighten regulations on medical devices, adding to pressure for radical change in the wake of a global scandal over French-made breast implants.
    "I see an urgent need to regulate devices at the same level of science and attention as with drugs," Guido Rasi, executive director of the European Medicines Agency (EMA), told Reuters.
    Medical devices are regulated in the European Union not by the EMA, but under the "CE mark" scheme, which is also used for household appliances such as electric toasters, a notably relaxed regime that has been criticised by doctors.
    In contrast to prescription medicines, devices need only a simple quality certification before being sold to the public.
    In his first published interview since taking office in November, Rasi added the bar for medicines was set to rise as new treatments were increasingly tested against active comparator drugs rather than placebos, or dummy products.
    Growing concerns about breast implants made by now-defunct French company Poly Implant Prothese (PIP) have focused attention on devices regulation, and could accelerate changes to rules governing the medical technology sector.
    "This might speed up some decisions," Rasi said.
    New proposals from the European Commission on regulating devices, including measures for more pre-market testing and post-marketing surveillance, are set to go before EU ministers this year.
    Unlike the U.S. Food and Drug Administration (FDA), the London-based EMA only has a mandate to regulate drugs, not devices.
    But Rasi said medicines and devices were increasingly converging as some products, such as coronary stents, are used to deliver drugs, so the EMA would in future need to look closely at the "borderline" area between the two fields.
    Whether the EMA should eventually have a full remit for devices as well as drugs is up to politicians. "We are civil servants; we will do what we are told to do," Rasi said.
    French Health Minister Xavier Bertrand also highlighted Europe's regulatory shortcomings on Thursday, arguing devices should go through the same rigorous review as medicines, with approval given either by national regulators or the EMA.
    Rasi cautioned, however, that overhauling the regulatory system could be a slow process.
    "There is resistance from sectors of the industry and resistance from some national authorities, so I don't expect anything fast, but we need something for public health protection," he said.
    Major makers of medical devices -- which range from stents and artificial heart valves to replacement hips and knees, as well as breast implants -- include Johnson & Johnson, Medtronic, Boston Scientific, Abbott Laboratories, Allergan and Smith & Nephew.
    NEW STANDARDS FOR DRUG TESTING
    A challenge for the EMA in future will be to work closely with national health technology assessment (HTA) agencies to ensure patients get access to new medicines at a time of cutbacks in government spending, Rasi said.
    This would include providing scientific advice on clinical trial design to drugmakers that need to satisfy the EMA their medicines are safe and effective and prove to agencies such as Britain's National Institute for Health and Clinical Excellence (NICE) that they offer value for money.
    The result, Rasi predicted, would be an increasing shift towards clinical trials that compare new drugs with existing treatments before approval.
    "I think, at the end of the day, we will see everyone moving to increasing use of comparative trials," Rasi said.
    The EMA has long encouraged such trials but has not made them compulsory. In future, comparative studies could become the default option, with the exception of treatments for rare diseases where there may be no alternatives.
    Commenting on the flow of new products coming out of drug company laboratories, Rasi said there were signs of a pick-up, with the EMA issuing a total of 87 "positive opinions" in 2011, up from 51 in 2010, including recommendations for generics.
    But many of the new medicines target relatively small sub-groups of patients, and may never become blockbusters.
    "There is a slight increase, but I don't know if that means we are back to the golden age of new drugs," he said.


    Exclusive - EU medicines head urges tougher implant rules | Reuters


  2. #2
    Thailand Expat
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    Presumably the surgeons who undertook the implants knew what they where implanting and took the decision to go ahead with the operation.

    These took money and should offer free extraction and replacement, with a new caveat in their contracts.

  3. #3
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    ^Exactly. No problem with women who have had mastectomies and had surgery to correct it getting free replacments, but any tart who got a tit-job out of vanity shouldn't expect the tax payer to bail them out.

    After all, they must have signed a consent form acknowledging the potential dangers and complications...fuck em, if they can afford the tits in the first place they can afford to take them out.

    BTW, I fucking hate fake tits-they look wrong, they feel wrong, and there is no knob stiffening jiggle to 'em, whats the point? I'd rather have a pert pair of small tits than some massive rock hard ones!

  4. #4
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    Unfortunately the poor suckers who had them implanted were probably not at well informed as the surgeons who installed them.

    if you had a hip replacement or a heart valve installed which the surgeon knew was suspect would you not sue for malpractice? Or do you thing the recipients were offer a cheap insert and knew about it?
    A tray full of GOLD is not worth a moment in time.

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