Guest guest Posted June 4, 2009 Report Share Posted June 4, 2009 This is a repost from one of our former group members.Vasey, B. M.D.; Mills, R. M.D.; Wells, Alvin F. M.D. > > Plastic & Reconstructive Surgery, Issue: > > Volume 108(7), December 2001, pp 2165-2166 > > > > Plastic and Reconstructive Surgery has recently published three > > important studies on the relationship of constitutional symptoms to > > silicone gel-filled breast implants. > > > > The first study, by Fryzek et al., showed that 20 of 28 symptoms > were > > statistically significantly increased in women with local implant > > complications compared with those without such complications. 1 > > > > The second study, by Fryzek et al., showed that all 28 symptoms were > > increased, and 16 were statistically significantly increased in > women > > with gel-filled silicone breast implants in comparison with women > who > > underwent reduction mammaplasty. (Mika: the reduction mammaplasty is > > just a control group against which they measured the women with > > implants. Both groups had surgeries on their breasts which makes > them > > equivalent on some factors, making their findings stronger) > > > > The third study, by Rohrich et al., showed improvement in a number > of > > musculoskeletal symptoms, general health, and feelings of depression > > after a relatively short follow-up of 6 months after implant > removal. > > 3 However, Rohrich et al. state that 50 percent of the explanted > women > > eventually chose to have their implants replaced. Any data concluded > > from these women will be biased because of their continued exposure > to > > silicone in the envelope of the saline-filled implants. Should these > > women continue to be included in the explanted group, the power of > the > > study to prove a statistically significant difference between groups > > is weakened. Therefore, women who have their implants replaced > should > > form a new category to be studied separately from those who remain > > explanted. The authors also questioned whether the improvement > > observed at 6 months would continue. > > > > We have performed a similar prospective study using a Likert scale > > (Mika: Scale which asks readers to rate something from 1 to 5 with > > 1-labeled 'very much' and 5 labeled 'not at all' or similar) with 36 > > signs and symptoms comparing symptomatic women who removed and did > not > > replace silicone gel-filled implants (n = 43) with those who decided > > to leave the implants in place despite being advised to consider > > removal (n = 52). 4 Six women who exchanged gel-filled for > > saline-filled implants were deleted from the study. Our average > > follow-up was 18 months, with slow steady improvement in the scores > > noted in the implant removal group. In addition, our study showed > > steady worsening in the women who left their implants in place. > > > > Additionally, just published is a Food and Drug Administration > study 5 > > offering magnetic resonance imaging of the breast to women with > > silicone gel breast implants. The study correlated fibromyalgia with > > extracapsular ruptures. The relative risk was 2.8. The absolute > > comparison was that 24.7 percent of women with extracapsular > ruptures > > had fibromyalgia, whereas 11 percent had fibromyalgia with either > > contained rupture or no rupture. There was no control group, but a > > house-to-house survey in Kansas showed a baseline fibromyalgia rate > of > > 2 percent. 6 > > > > Together, these studies provide further evidence that silicone > causes > > a new rheumatic syndrome that rheumatologists have named > > silicone-related disorder. > > > > After seeing approximately 1500 affected women over the past 15 > years, > > several clinical observations (Mika: aka women seen by medical > > practitioners, rather than women in studies) have been helpful in > > making the diagnosis of silicone-related disorder. These women also > > have both local and diffuse musculoskeletal complaints. The diffuse > > symptoms of the disorder are similar to those of fibromyalgia > > including muscle pain, chronic fatigue, and multiple trigger points. > > However, unlike naturally occurring fibromyalgia, exercise > aggravates > > the muscle pain. Most symptomatic women will have bladder > dysfunction. > > Symptoms include frequency, dysuria, urgency, nocturia, and even > > hematuria. These symptoms are similar to those seen with urinary > tract > > infections but with sterile cultures. We suspect that the > > disintegration and spread and ultimate excretion of silica debris > > through the urinary system cause local bladder irritation even to > the > > point of interstitial cystitis. > > > > Once a diagnosis of silicone-related disorder is established, the > > patient should be told to consider removal of the implants. Most > women > > with this disorder stabilize after implant removal but have variable > > rates of recovery. Most women tend to improve very slowly over time. > > We have identified three adverse events that predict a longer > recovery > > and a more severe illness: women with prompt onset of constitutional > > symptoms in the first 2 years after implant placement; delayed > removal > > of implants despite worsening symptoms; and gross extracapsular > > rupture with spread of silicone debris in the chest wall. > > > > Epidemiological studies have focused on rare or unusual rheumatic > > disorders such as scleroderma, systemic lupus erythematosus, and > > undifferentiated connective tissue diseases. Fibromyalgia and > chronic > > fatigue syndrome have been systematically excluded from > > epidemiological study with the exception of Scandinavian studies of > > hospital records. Fibromyalgia and chronic fatigue patients are not > > usually hospitalized, limiting the usefulness of these studies as > well. > > > > Very few data are available to guide physicians in advising women > with > > silicone-related disorder for or against replacement with > > saline-filled breast implants. In a cross-sectional study of 32 > > symptomatic women who replaced their gel-filled implants with > > saline-filled (silicone envelope) implants, only 30 percent improved > > over 18 months. 7 In comparison, our original series showed that 70 > > percent of the women who removed their implants and left them out > for > > years had significant improvement. 8 We have also seen women relapse > > after replacement with saline-filled implants. We believe the > silicone > > envelope is enough to aggravate the already silicone-sensitized > immune > > system in some women. Larger-scale long-term studies are needed to > > give women adequate information about the risks of replacement of > > silicone gel-filled implants with saline implants. Until then, women > > should be cautioned about the potential for adverse consequences. > > > > As always, women need to weigh the cosmetic benefits of having > breast > > implants against the gradually improving understanding of the risks. > > We believe the incidence of a silicone immune sensitization syndrome > > will be lower with a smaller amount of silicone exposure in > > saline-filled implants in comparison with the gel-filled implants. > > Some women's immune systems will not tolerate even saline-filled > > silicone envelope implants. > > > > The silicone breast implant controversy continues. All four recent > > studies support our concern that not all women's bodies will > tolerate > > silicone implants. Women who develop an unexplained chronic > > fatigue/fibromyalgi a-like illness after augmentation with either > > silicone gel-filled or saline-filled implants should strongly > consider > > implant removal. > > > > B. Vasey, M.D. > > > > R. Mills, M.D. > > > > Alvin F. Wells, M.D. Quote Link to comment Share on other sites More sharing options...
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