Article on silicone implants/saline and fibromyalgia

April 18, 2008

Hey All,

I found this article very enlightening. It's a bit old (2001) but I'm

still catching up on my research :-) I added some comments (in

brackets with my name included to elaborate on some of the scientific

jargon).

Mika

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/fibromyalgia-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.

April 18, 2008

This is an excellent article. I'm so glad you posted it.

Here's the info I found important to know:

We have identified three adverse events that predict a longer recovery

and a more severe illness:

1)women with prompt onset of constitutional

symptoms in the first 2 years after implant placement;

2) delayed removal of implants despite worsening symptoms; and

3)gross extracapsular rupture with spread of silicone debris in the

chest wall.

I certainly experienced a longer recovery and a more severe illness

after I got sick within 8 months of implantation.

For those who are ill now, don't delay in getting those implants out

ASAP!!!

Patty

>

> Hey All,

>

> I found this article very enlightening. It's a bit old (2001) but

I'm

> still catching up on my research :-) I added some comments (in

> brackets with my name included to elaborate on some of the

scientific

> jargon).

>

> Mika

>

> 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/fibromyalgia-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.

>

April 18, 2008

Hi Patty,

Thank you for extracting the key info from that article. I also found

the addition of 'silicone related disorder' to be medical

practitioners discourse refreshing. No more of them telling us its all

in our heads.

Unfortunately I'm also in the category of women that might take a

while to recover. My symptoms came on a year after surgery. I got very

sick then with non-stop pain. It turns out that my implant was

raptured from the start and I guess the silicone shell might have been

in a poor shape. 5 years later the implant became fully deflated and

only then did my plastic surgeon agree that I did have a leak all this

time. I got better after they replaced that 1 implant and have been

so-so since then. Recently I was worse again, but I have only 2 more

months till the en-bloc explantation.

For all of you ladies from Canada, I found it very easy to have health

insurance cover my explant surgery (in full) at least in case where

you are in pain and/or sick. If you see a doctor who specializes in

performing explants, he/she will know what to do and will apply on

your behalf. I'm being explanted by Dr Kuusk (Vancouver) and she

certainly knows the process.

Mika.

> >

> > Hey All,

> >

> > I found this article very enlightening. It's a bit old (2001) but

> I'm

> > still catching up on my research :-) I added some comments (in

> > brackets with my name included to elaborate on some of the

> scientific

> > jargon).

> >

> > Mika

> >

> > 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/fibromyalgia-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.

> >

>

April 18, 2008

Mika,I wonder, with Canadian health care paying for explant, and doctor becoming aware that breast implants can lead to serious issues, how long it will be before Canada starts banning breast implants? . .. If ever.I'm certainly glad to hear you're getting your implants out, and that you have an excellent doctor.Hugs and prayers,Rogene

Re: Article on silicone implants/saline and fibromyalgia