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FDA: Breast Implants Eventually Need To Be Removed Or Fixed

June 24, 2011 by  

FDA: Breast Implants Eventually Need To Be Removed Or Fixed

The Food and Drug Administration (FDA) issued an update Wednesday to its safety guidelines and recommendations regarding silicone breast implants.

“Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use,” the FDA said in a statement on its website.

However, the FDA also found that “the longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes. Women with breast implants will need to monitor their breasts for local complications for the rest of their lives… Recognize that breast implants are not lifetime devices. The longer you have your implants, the more likely it will be for you to have them removed.”

The FDA reached these conclusions after reviewing updated industry studies and literature.

The FDA recommended that women with breast implants receive regular checkups with their doctors to monitor the implants for damage, and to “notify your health care provider if you develop any unusual signs or symptoms including pain, asymmetry, hardness or swelling.”

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  • Cawmun Cents

    Vanity is a deadly sin.This nation has been taught through the media outlets and advertising,as well as Hollywood,that vanity is a good thing.The place where a woman puts on her mask everyday is actually called a vanity.What a shame.Beauty and perfection on the outside is seen as virtuous.But the inside can be a mess and it is all forgiven if the outside looks good.Can anyone here draw a parallel to the way our nation is being run today?Painting the face with an image that looks great in the mirror,but behind the flesh there is no substance?Live like there is no tommorow and leave a pretty corpse?That is what is being taught to our children.Have a surgeon fix the outside to look fabulous(just look at Joan Rivers)but leave the inside a brutal mess,and you will be okay!.Bolt on a large bustline and the world is your oyster Frankenstein.The world is watching your waistline and how you look in a bikini,but the fact that you whore yourself to the world has gone un-noticed,right?But the pharmaceutical companies will bail you out of this funk,right?Ron White said it best,”You cant fix stupid!”But you can dress it up to look smart,right?-CC.

    • coal miner

      Make the Right Choice of Herbal Product
      Breast Active:

      The Dangers of Breast Implants

      Just take a look at the statistics: about 35% of women experience transplant leakage in the first three years. What does it mean? It simply means that your breasts that suddenly started to look so great deflate.

      Eventually, any breast implant can leak or simply break – there is no insurance against that. The filling of the implant might be saline or gel. Saline will most probably adsorb into the body and have no negative effects. Implants that are a bit older and have silicon inside are also prone to leakage. There are several ways this might happen. If it happens so that the shell of the implant suddenly breaks, you might not even feel something is wrong, especially if a contracture scar is present. In case there is no contracture scar, the material that has been leaking accumulates in breast tissues and later can travel via your lymphatic system and get to another part of the body. So, of course, if gel from the implant managed to migrate to another area of your body, it’s clear that removing all the gel along with the implant is not possible. And this creates a serious problem as the silicone that leaked might cause harm to the body tissues.

      What are the most common causes for breakages and later leakages? These include a careless move with a metal object during the operation, putting too much or too little solution into the implant (especially if there is pure saline solution inside), a contraction of the capsule, a physical trauma as a result of injury, strenuous exercise, as well as just the age factor – as the implant is getting older it’s getting less and less reliable.

      The American Food and Drug Administration (FDA) carried out research that had the purpose of establishing the reason for the breakage of implants filled with silicone. The research involved examining women with breast implants put in before 1988 and finding out the condition of their implants. All in all, 55% of the examined women had some ruptures of implants, which means that most of them also had leakages of gel into the breast tissues. The factors that contributed to that were, among others, the age of the implants themselves, the company that manufactured them and their location. The study proved something that has been discussed for years but for some reason didn’t become public until then. It also proved that no matter what material is used in your breast implant, there is always a good chance it is not going to withstand certain things.

      Capsular contracture is one of the most frequent causes of problems with breast implants. The following thing happens: the scar tissue that grows around the implant as a natural reaction of your organism to the invasion of an extraneous body becomes tighter. There is nothing wrong with it as this is how the process of healing happens all the time. However, because implants are so vulnerable to any changes, sometimes another surgery might be required to eliminate the scar tissue or even replace the breast implant. There can be several of such operations – everything depends on how your body is going to take it. In another research study that was aimed at examining implants with saline solution it was discovered that the percentage of people suffering from such complications is quite big – 9% for augmentation patients and around 25-30% for reconstruction patients. This is something serious to think about before you make up your mind about having a breast implant surgically put inside your body.

  • C130 Gunship

    I for one, would greatly appreciate if you ladies would also remove your tramp stamp on the back of your ass while getting your fake tits fixed or removed. I’m just sayin’.

  • skippy

    LOL @ C130!!! never heard the expression ‘tramp stamp’…but I like it!! :D

  • Bus

    I’m disappointed, with an article like this you had a chance to put a real great picture up as your attention grabber. You failed, just as putting foreign objects in your body will probably fail eventually as well.

  • FlaJim

    Never understood why the wimmin folk thought they needed these things in the first place. If that’s all they’ve got to offer, that’s slim pickings.

    [comment removed] I’m in agreement with Bus, above, though. Brings to mind an old sign in china shops: Lovely to see, lovely to hold; if you break it, consider it sold.

    Got lots more but better quit while I’m ahead.

  • Mason

    We’re getting too obsessed with how we look over what actually ticks inside a person. I value intellegence and personal value over beauty. I’m not saying I’ll date someone who looks like they’ve taken one too many axes to the face, but there’s no way in hell I’m dating an absoloute airhead

  • coal miner

    close Loading Image…
    Science News Share Blog Cite Print Bookmark Email
    Common Drugs Linked to Cognitive Impairment and Possibly to Increased Risk of Death, Study Suggests
    ScienceDaily (June 24, 2011) — A large, long-term study confirms that medications with anticholinergic activity, which include many drugs frequently taken by older adults, cause cognitive impairment. The research is also the first to identify a possible link between these drugs — which include over-the-counter and prescription sleep aids and incontinence treatments — and risk of death.
    The two-year study of the impact of these medications on 13,000 men and women aged 65 and older is part of the Medical Research Council (UK) Cognitive Function and Ageing Studies (CFAS), a large UK-based longitudinal multi-center study initiative looking at health and cognitive function in older adults. Results of the study of anticholinergics appear June 24, 2011 in an advanced online publication of the Journal of the American Geriatrics Society.

    Anticholinergics affect the brain by blocking acetylcholine, a nervous system neurotransmitter. Over-the-counter products containing diphenhydramine, sold under various brand names such as Benadryl®, Dramamine®, Excedrin PM®, Nytol®, Sominex®, Tylenol PM®, and Unisom®, have anticolinergic activity. Other anticholinergic drugs, such as Paxil®, Detrol®, Demerol® and Elavil® are available by prescription.

    “Our findings make it clear that clinicians need to review the cumulative anticholinergic burden in people presenting with cognitive impairment to determine if the drugs are causing decline in mental status,” said co-author Malaz Boustani, M.D., Regenstrief Institute investigator, Indiana University School of Medicine associate professor of medicine, and research scientist with the IU Center for Aging Research.

    “Physicians should review with older patients all the over-the-counter and prescription drugs they are taking to determine exposure,” said Dr. Boustani a geriatrician who sees patients at Wishard Health Services’ Healthy Aging Brain Center in Indianapolis.

    The researchers, led by Chris Fox, M.D., of the University of East Anglia and Carol Brayne, M.D. of the University of Cambridge, used the Anticholinergic Cognitive Burden Scale developed by Dr. Boustani and colleagues at the Regenstrief Institute, Indiana University and in the United Kingdom to evaluate the link between anticholinergic activity and cognitive decline.

    Medications with anticholinergic effects are used for many diseases including hypertension and congestive heart failure. The study found that older age, lower income, and greater number of health conditions increased use of medications with anticholinergic activity. Women were more likely to report taking anticholinergic medications, due to the greater number of health conditions reported by women than by men. Participants living in institutions were more likely to report taking anticholinergic medications.

    “We looked at drugs with either moderate and severe anticholinergic activity. After adjusting for age, sex, baseline mental status, education, income level, number of non-anticholinergic medications and health conditions, we found that taking anticholinergic medications was linked to cognitive impairment and for the first time to death,” said study corresponding author Dr. Fox, a psychiatrist. “We need follow-up to determine the degree to which anticholinergics are being prescribed for diseases with significant risk of death and the impact of that on our findings.”

    Authors of the study are Chris Fox, M.D., University of East Anglia; Carol Brayne, M.D., Kathryn Richardson, M.Sc. and George M. Savva, Ph.D, University of Cambridge; Ian D. Maidment, M.A., Kent and Medway NHS and Social Care Partnership Trust; Fiona E. Matthews, Ph.D., Medical Research Council Biostatistics Unit; David Smithard, M.D., Kent Community Health NHS Trust; Simon Coulton M.Sc., University of Kent; Cornelius Katona, M.D., University College London and Malaz Boustani, M.D., M.P.H., Regenstrief Institute, Indiana University School of Medicine and IU Center for Aging Research.

    “The Anticholinergic Medication Use and Cognitive Impairment in the Older Population: The Medical Research Council Cognitive Function and Ageing Study (CFAS)” was funded by the Medical Research Council.

    “The Medical Research Council invests in cohort studies like CFAS because they provide vital clinical information through observation. Such projects require long-term commitment to fulfill their potential but having supported cohort studies for well over half a century, MRC funding and collaborations have made us an international leader in this field,” said Chris Kennard, MBBS, Ph.D., chairman of the MRC’s Neuroscience and Mental Health Board.

    Dr. Boustani’s development of the Anticholinergic Burden Scale was supported by the U.S. National Institute on Aging.

  • James

    Installing some manmade device, for whatever reason, into the human body, should be made a capital offense. They have violated the laws of nature and its God.


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