Dr. Pierre Blais on retained capsules

[Guest guest]

Thanks Lea! This is valuable information!

>

> Pierre Blais Ph. D.

> Residual Capsule and Intercapsular Debris As

> Long Term Risk Factors.

> >

> Contamination of the space between the

> capsule and the implants by micro- organisms,

> silicone oils, degradation products and gel

> impurities constitutes a major problem which

> potentiates the risk of implants. Such problems

> include inflammation, infection, deposition of

> mineral debris, as well as certain auto-immune

> phenomena. These problems can be present when

> implants are in situ (in the body) and are often

> attributable to the implant. The logical expectation

> is that, upon removal of the implants, adverse

> effects will cease. This is an unjustifiably

> optimistic view. It is well documented from case

> histories that removal and or replacement of

> implants without exhaustive debridement of the

> prosthetic site leads to failure and post surgical

> complications.

>

> Plastic surgery procedures tend to favor

> speed and immediate cosmetic results. For these

> reasons, leaving or " reusing " tissue from an

> existing capsule may seem more " gratifying " However,

> adverse effects resulting from the practice are

> widespread but have not been well documented.

> Typically, patients who require removal of faulty

> implants and undergo immediate re-implantation in

> the same prosthetic site habitually relapse with the

> same problem which motivated the previous surgery;

> the most common example is exchange of implants

> and/or sectorizing or bisecting the capsule without

> removing it completely.

>

> Such patients rarely achieve a

> significant capsular correction and habitually

> return for more similar surgery. A more illustrative

> situation is that where patients do not receive

> replacement implants. They form the basis of

> knowledge for evaluating the risks that arise from

> remaining capsules. An example is described in a

> paper published in 1993 (Copeland, M., Kessel, A.,

> Spiera, H., Hermann, G., Bleiweiss, I. J.; Systemic

> Inflammatory Disorder Related To Fibrous Breast

> Capsules After Silicone Implant Removal; Plastic and

> Reconstructive Surgery: 92 (6), 1179-1181, 1993):

> reported problems derived primarily from immune

> phenomena and inflammatory syndromes with pain,

> swelling, serologic abnormaladies and alarming

> radiologic presentation.

>

> Numerous similar cases have been noted

> amongst implant patients but have not been theobject

> of publications. Some are cited in FDA Reaction

> Reports. Others appear in theU.S. Pharmacopoeia

> Reporting Programs.

>

> A residual capsule is not a stable

> entity. It may collapse upon completion of surgery

> and remain asymptomatic for some time, however, it

> will fill with extracellular fluid and remain as a

> fluid-filled space with added blood and prosthetic

> debris. As the wall matures and the breast remodels

> to accommodate the loss of the prostheses, the

> capsular tissue shrinks. Water as well as

> electrolytes are expelled gradually from the pocket

> or else the mixture is concentrated from leakage of

> water from the semi-permeable capsular membrane

> wall.

>

> In most cases, calcium salts precipitate

> during that stage and may render the capsule visible

> as a radiodense and speckled zone in radiographic

> projections. Prosthetic debris is also radiodense

> and may be imaged to further complicate the

> presentation. The average size of the residual

> capsules after 6-12 months is in the 2-7 cm range:

> most are compact, comparatively small and dense.

> Surgical removal should present no difficulty for

> most patients if adequate radiographic information

> is available.

>

> Later stages of maturation include the

> thickening of the capsule wall, sometimes reaching

> 0.5-1cm. Compression of the debris into a cluster of

> nodules which actually become calcified follows for

> some patients. A few mimic malignancies. Others

> appear as small " prostheses " during mammographic

> studies. They are alarming to onocologists and are

> habitually signalled for further studies or biopsies

> by oncologic radiologists.

>

> In light of the present knowledge and

> considering the probable content of the residual

> closed capsules, an open or needle biopsy is not

> advisable. The risks of releasing significant

> amounts of hazardous contamination and possibly

> spreading infective entities outweighs the advantage

> of the diagnostic. At any rate, such a capsule

> requires removal for mitigation of symptoms and a

> more direct surgical approach appears more

> economical and less risky.

>

> In summary, a capsule with a dense

> fibro-collagenous wall behaves as a bioreactor.

> Worse yet, it is fitted with a semi-permeable wall

> that may periodically open to release its content to

> the breast. The probability of finding the space

> colonized with atypical micro-organisms is elevated

> and the control of infective processes by classic

> pharmacologic approaches is difficult if not

> impossible.

>

> Such closed capsular spaces may be

> comparable to " artificial organs " of unpredictable

> functions. Their behavior will depend on the content

> and the age of the structure, its maturity and the

> history of the patient. There is a high probability

> that these capsules will continue to evolve for many

> years, adding more layers of fibro-collagenous

> tissue and possibly granulomatous material. If

> bacterial entities are present within the capsule

> space, they can culminate in large breast abscesses

> with will resist conservative treatments.

>

> Even with less active capsules

> containing mostly oily and calcitic debris, the

> thickening of the wall leads eventually to solid

> " tumor-like structures " and are, by themselves,

> alarming on auscultation and self examination. At

> best, such structures are unique environments for

> protein denaturation and aberrant biochemical

> reactions with unknown long term consequences.

>

> Pierre Blais, Ph.D.

>

> Innoval 496 Westminster Ave.

>

> Ottawa, Ontario

>

> Canada KeA 2V1

>

> Phone: (613) 728-8688

>

> Fax: (613) 728-0687

>

> Pierre Blais, PhD received his

> undergraduate and graduate degrees in

> physical-organic polymer chemistry from McGill

> University in Montreal, Canada, and a Post-doctorate

> Fellowship in biomaterials engineering at Case

> Western University in Cleveland, Ohio. In 1976 he

> became one of the first scientists to join the

> medical devices and radiological health program of

> the Department of Health and Welfare in Canada. He

> left the department in 1989 as Senior Scientific

> Advisor and formed Innoval Consultants, a firm

> engaged in the design, testing and failure analysis

> of high risk medical systems. He has authored over

> 250 publications on medical materials and their

> interactions with living tissues.

>

>

>

>

>

[Guest guest]

This is for one of the ladies who wanted information on Dr. Blais:

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~````

> Dr. Pierre Blais on retained capsules

>

>

>> Thanks Lea! This is valuable information!

>>

>>>

>>> Pierre Blais Ph. D.

>>

>>> Residual Capsule and Intercapsular Debris As

>>> Long Term Risk Factors.

>>> >

>>> Contamination of the space between the

>>> capsule and the implants by micro- organisms,

>>> silicone oils, degradation products and gel

>>> impurities constitutes a major problem which

>>> potentiates the risk of implants. Such problems

>>> include inflammation, infection, deposition of

>>> mineral debris, as well as certain auto-immune

>>> phenomena. These problems can be present when

>>> implants are in situ (in the body) and are often

>>> attributable to the implant. The logical expectation

>>> is that, upon removal of the implants, adverse

>>> effects will cease. This is an unjustifiably

>>> optimistic view. It is well documented from case

>>> histories that removal and or replacement of

>>> implants without exhaustive debridement of the

>>> prosthetic site leads to failure and post surgical

>>> complications.

>>>

>>> Plastic surgery procedures tend to favor

>>> speed and immediate cosmetic results. For these

>>> reasons, leaving or " reusing " tissue from an

>>> existing capsule may seem more " gratifying " However,

>>> adverse effects resulting from the practice are

>>> widespread but have not been well documented.

>>> Typically, patients who require removal of faulty

>>> implants and undergo immediate re-implantation in

>>> the same prosthetic site habitually relapse with the

>>> same problem which motivated the previous surgery;

>>> the most common example is exchange of implants

>>> and/or sectorizing or bisecting the capsule without

>>> removing it completely.

>>>

>>> Such patients rarely achieve a

>>> significant capsular correction and habitually

>>> return for more similar surgery. A more illustrative

>>> situation is that where patients do not receive

>>> replacement implants. They form the basis of

>>> knowledge for evaluating the risks that arise from

>>> remaining capsules. An example is described in a

>>> paper published in 1993 (Copeland, M., Kessel, A.,

>>> Spiera, H., Hermann, G., Bleiweiss, I. J.; Systemic

>>> Inflammatory Disorder Related To Fibrous Breast

>>> Capsules After Silicone Implant Removal; Plastic and

>>> Reconstructive Surgery: 92 (6), 1179-1181, 1993):

>>> reported problems derived primarily from immune

>>> phenomena and inflammatory syndromes with pain,

>>> swelling, serologic abnormaladies and alarming

>>> radiologic presentation.

>>>

>>> Numerous similar cases have been noted

>>> amongst implant patients but have not been theobject

>>> of publications. Some are cited in FDA Reaction

>>> Reports. Others appear in theU.S. Pharmacopoeia

>>> Reporting Programs.

>>>

>>> A residual capsule is not a stable

>>> entity. It may collapse upon completion of surgery

>>> and remain asymptomatic for some time, however, it

>>> will fill with extracellular fluid and remain as a

>>> fluid-filled space with added blood and prosthetic

>>> debris. As the wall matures and the breast remodels

>>> to accommodate the loss of the prostheses, the

>>> capsular tissue shrinks. Water as well as

>>> electrolytes are expelled gradually from the pocket

>>> or else the mixture is concentrated from leakage of

>>> water from the semi-permeable capsular membrane

>>> wall.

>>>

>>> In most cases, calcium salts precipitate

>>> during that stage and may render the capsule visible

>>> as a radiodense and speckled zone in radiographic

>>> projections. Prosthetic debris is also radiodense

>>> and may be imaged to further complicate the

>>> presentation. The average size of the residual

>>> capsules after 6-12 months is in the 2-7 cm range:

>>> most are compact, comparatively small and dense.

>>> Surgical removal should present no difficulty for

>>> most patients if adequate radiographic information

>>> is available.

>>>

>>> Later stages of maturation include the

>>> thickening of the capsule wall, sometimes reaching

>>> 0.5-1cm. Compression of the debris into a cluster of

>>> nodules which actually become calcified follows for

>>> some patients. A few mimic malignancies. Others

>>> appear as small " prostheses " during mammographic

>>> studies. They are alarming to onocologists and are

>>> habitually signalled for further studies or biopsies

>>> by oncologic radiologists.

>>>

>>> In light of the present knowledge and

>>> considering the probable content of the residual

>>> closed capsules, an open or needle biopsy is not

>>> advisable. The risks of releasing significant

>>> amounts of hazardous contamination and possibly

>>> spreading infective entities outweighs the advantage

>>> of the diagnostic. At any rate, such a capsule

>>> requires removal for mitigation of symptoms and a

>>> more direct surgical approach appears more

>>> economical and less risky.

>>>

>>> In summary, a capsule with a dense

>>> fibro-collagenous wall behaves as a bioreactor.

>>> Worse yet, it is fitted with a semi-permeable wall

>>> that may periodically open to release its content to

>>> the breast. The probability of finding the space

>>> colonized with atypical micro-organisms is elevated

>>> and the control of infective processes by classic

>>> pharmacologic approaches is difficult if not

>>> impossible.

>>>

>>> Such closed capsular spaces may be

>>> comparable to " artificial organs " of unpredictable

>>> functions. Their behavior will depend on the content

>>> and the age of the structure, its maturity and the

>>> history of the patient. There is a high probability

>>> that these capsules will continue to evolve for many

>>> years, adding more layers of fibro-collagenous

>>> tissue and possibly granulomatous material. If

>>> bacterial entities are present within the capsule

>>> space, they can culminate in large breast abscesses

>>> with will resist conservative treatments.

>>>

>>> Even with less active capsules

>>> containing mostly oily and calcitic debris, the

>>> thickening of the wall leads eventually to solid

>>> " tumor-like structures " and are, by themselves,

>>> alarming on auscultation and self examination. At

>>> best, such structures are unique environments for

>>> protein denaturation and aberrant biochemical

>>> reactions with unknown long term consequences.

>>>

>>> Pierre Blais, Ph.D.

>>>

>>> Innoval 496 Westminster Ave.

>>>

>>> Ottawa, Ontario

>>>

>>> Canada KeA 2V1

>>>

>>> Phone: (613) 728-8688

>>>

>>> Fax: (613) 728-0687

>>>

>>> Pierre Blais, PhD received his

>>> undergraduate and graduate degrees in

>>> physical-organic polymer chemistry from McGill

>>> University in Montreal, Canada, and a Post-doctorate

>>> Fellowship in biomaterials engineering at Case

>>> Western University in Cleveland, Ohio. In 1976 he

>>> became one of the first scientists to join the

>>> medical devices and radiological health program of

>>> the Department of Health and Welfare in Canada. He

>>> left the department in 1989 as Senior Scientific

>>> Advisor and formed Innoval Consultants, a firm

>>> engaged in the design, testing and failure analysis

>>> of high risk medical systems. He has authored over

>>> 250 publications on medical materials and their

>>> interactions with living tissues.

>>>

>>>

>>>

>>>

>>>

>>

>>

>>

>>

>> Opinions expressed are NOT meant to take the place of advice given by

>> licensed health care professionals. Consult your physician or licensed

>> health care professional before commencing any medical treatment.

>>

>> " Do not let either the medical authorities or the politicians mislead

you.

>> Find out what the facts are, and make your own decisions about how to

live

>> a happy life and how to work for a better world. " - Linus ing,

>> two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

>>

>>

[Guest guest]

Lea, that's an incredible bunch of info!

I'm seeing my family doctor on Wednesday for my latest x-ray

results. Do capsules show up in an x-ray? MRI? I got a copy of my

surgery results, however my level of trust is such that I have to see

with my own eyes that they ARE out.

Dr. Blais is absolutely AWESOME! I still haven't contacted his

office to make sure my implants actually made it there. I also want

to know who manufactured my implants.

Love & Constant Prayer,

Sunny

>

> This is for one of the ladies who wanted information on Dr. Blais:

> > ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~````

> > Dr. Pierre Blais on retained capsules

> >

> >

> >> Thanks Lea! This is valuable information!

> >>

> >>>

> >>> Pierre Blais Ph. D.

> >>

> >>> Residual Capsule and Intercapsular Debris As

> >>> Long Term Risk Factors.

> >>> >

> >>> Contamination of the space between the

> >>> capsule and the implants by micro- organisms,

> >>> silicone oils, degradation products and gel

> >>> impurities constitutes a major problem which

> >>> potentiates the risk of implants. Such problems

> >>> include inflammation, infection, deposition of

> >>> mineral debris, as well as certain auto-immune

> >>> phenomena. These problems can be present when

> >>> implants are in situ (in the body) and are often

> >>> attributable to the implant. The logical expectation

> >>> is that, upon removal of the implants, adverse

> >>> effects will cease. This is an unjustifiably

> >>> optimistic view. It is well documented from case

> >>> histories that removal and or replacement of

> >>> implants without exhaustive debridement of the

> >>> prosthetic site leads to failure and post surgical

> >>> complications.

> >>>

> >>> Plastic surgery procedures tend to favor

> >>> speed and immediate cosmetic results. For these

> >>> reasons, leaving or " reusing " tissue from an

> >>> existing capsule may seem more " gratifying " However,

> >>> adverse effects resulting from the practice are

> >>> widespread but have not been well documented.

> >>> Typically, patients who require removal of faulty

> >>> implants and undergo immediate re-implantation in

> >>> the same prosthetic site habitually relapse with the

> >>> same problem which motivated the previous surgery;

> >>> the most common example is exchange of implants

> >>> and/or sectorizing or bisecting the capsule without

> >>> removing it completely.

> >>>

> >>> Such patients rarely achieve a

> >>> significant capsular correction and habitually

> >>> return for more similar surgery. A more illustrative

> >>> situation is that where patients do not receive

> >>> replacement implants. They form the basis of

> >>> knowledge for evaluating the risks that arise from

> >>> remaining capsules. An example is described in a

> >>> paper published in 1993 (Copeland, M., Kessel, A.,

> >>> Spiera, H., Hermann, G., Bleiweiss, I. J.; Systemic

> >>> Inflammatory Disorder Related To Fibrous Breast

> >>> Capsules After Silicone Implant Removal; Plastic and

> >>> Reconstructive Surgery: 92 (6), 1179-1181, 1993):

> >>> reported problems derived primarily from immune

> >>> phenomena and inflammatory syndromes with pain,

> >>> swelling, serologic abnormaladies and alarming

> >>> radiologic presentation.

> >>>

> >>> Numerous similar cases have been noted

> >>> amongst implant patients but have not been theobject

> >>> of publications. Some are cited in FDA Reaction

> >>> Reports. Others appear in theU.S. Pharmacopoeia

> >>> Reporting Programs.

> >>>

> >>> A residual capsule is not a stable

> >>> entity. It may collapse upon completion of surgery

> >>> and remain asymptomatic for some time, however, it

> >>> will fill with extracellular fluid and remain as a

> >>> fluid-filled space with added blood and prosthetic

> >>> debris. As the wall matures and the breast remodels

> >>> to accommodate the loss of the prostheses, the

> >>> capsular tissue shrinks. Water as well as

> >>> electrolytes are expelled gradually from the pocket

> >>> or else the mixture is concentrated from leakage of

> >>> water from the semi-permeable capsular membrane

> >>> wall.

> >>>

> >>> In most cases, calcium salts precipitate

> >>> during that stage and may render the capsule visible

> >>> as a radiodense and speckled zone in radiographic

> >>> projections. Prosthetic debris is also radiodense

> >>> and may be imaged to further complicate the

> >>> presentation. The average size of the residual

> >>> capsules after 6-12 months is in the 2-7 cm range:

> >>> most are compact, comparatively small and dense.

> >>> Surgical removal should present no difficulty for

> >>> most patients if adequate radiographic information

> >>> is available.

> >>>

> >>> Later stages of maturation include the

> >>> thickening of the capsule wall, sometimes reaching

> >>> 0.5-1cm. Compression of the debris into a cluster of

> >>> nodules which actually become calcified follows for

> >>> some patients. A few mimic malignancies. Others

> >>> appear as small " prostheses " during mammographic

> >>> studies. They are alarming to onocologists and are

> >>> habitually signalled for further studies or biopsies

> >>> by oncologic radiologists.

> >>>

> >>> In light of the present knowledge and

> >>> considering the probable content of the residual

> >>> closed capsules, an open or needle biopsy is not

> >>> advisable. The risks of releasing significant

> >>> amounts of hazardous contamination and possibly

> >>> spreading infective entities outweighs the advantage

> >>> of the diagnostic. At any rate, such a capsule

> >>> requires removal for mitigation of symptoms and a

> >>> more direct surgical approach appears more

> >>> economical and less risky.

> >>>

> >>> In summary, a capsule with a dense

> >>> fibro-collagenous wall behaves as a bioreactor.

> >>> Worse yet, it is fitted with a semi-permeable wall

> >>> that may periodically open to release its content to

> >>> the breast. The probability of finding the space

> >>> colonized with atypical micro-organisms is elevated

> >>> and the control of infective processes by classic

> >>> pharmacologic approaches is difficult if not

> >>> impossible.

> >>>

> >>> Such closed capsular spaces may be

> >>> comparable to " artificial organs " of unpredictable

> >>> functions. Their behavior will depend on the content

> >>> and the age of the structure, its maturity and the

> >>> history of the patient. There is a high probability

> >>> that these capsules will continue to evolve for many

> >>> years, adding more layers of fibro-collagenous

> >>> tissue and possibly granulomatous material. If

> >>> bacterial entities are present within the capsule

> >>> space, they can culminate in large breast abscesses

> >>> with will resist conservative treatments.

> >>>

> >>> Even with less active capsules

> >>> containing mostly oily and calcitic debris, the

> >>> thickening of the wall leads eventually to solid

> >>> " tumor-like structures " and are, by themselves,

> >>> alarming on auscultation and self examination. At

> >>> best, such structures are unique environments for

> >>> protein denaturation and aberrant biochemical

> >>> reactions with unknown long term consequences.

> >>>

> >>> Pierre Blais, Ph.D.

> >>>

> >>> Innoval 496 Westminster Ave.

> >>>

> >>> Ottawa, Ontario

> >>>

> >>> Canada KeA 2V1

> >>>

> >>> Phone: (613) 728-8688

> >>>

> >>> Fax: (613) 728-0687

> >>>

> >>> Pierre Blais, PhD received his

> >>> undergraduate and graduate degrees in

> >>> physical-organic polymer chemistry from McGill

> >>> University in Montreal, Canada, and a Post-doctorate

> >>> Fellowship in biomaterials engineering at Case

> >>> Western University in Cleveland, Ohio. In 1976 he

> >>> became one of the first scientists to join the

> >>> medical devices and radiological health program of

> >>> the Department of Health and Welfare in Canada. He

> >>> left the department in 1989 as Senior Scientific

> >>> Advisor and formed Innoval Consultants, a firm

> >>> engaged in the design, testing and failure analysis

> >>> of high risk medical systems. He has authored over

> >>> 250 publications on medical materials and their

> >>> interactions with living tissues.

> >>>

> >>>

> >>>

> >>>

> >>>

> >>

> >>

> >>

> >>

> >> Opinions expressed are NOT meant to take the place of advice

given by

> >> licensed health care professionals. Consult your physician or

licensed

> >> health care professional before commencing any medical

treatment.

> >>

> >> " Do not let either the medical authorities or the politicians

mislead

> you.

> >> Find out what the facts are, and make your own decisions about

how to

> live

> >> a happy life and how to work for a better world. " - Linus

ing,

> >> two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

> >>

> >>