Fw: Dr. Blais on Removing Capsules ... VERY IMPORTANT TO READ PRE-EXPLANT

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This is for the new ladies...love to you all...Lea

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Dr. Blais on Removing Capsules ... VERY IMPORTANT TO READ PRE-EXPLANTResidual Capsule and Intercapsular Debris As Long Term Risk Factors.Contamination of the space between the capsule and the implants bymicro- organisms, silicone oils, degradation products and gelimpurities constitutes a major problem which potentiates the risk ofimplants. Such problems include inflammation, infection, depositionof mineral debris, as well as certain auto-immune phenomena. Theseproblems can be present when implants are in situ (in the body) andare often attributable to the implant. The logical expectation isthat, upon removal of the implants, adverse effects will cease. Thisis an unjustifiably optimistic view. It is well documented from casehistories that removal and or replacement of implants withoutexhaustive debridement of the prosthetic site leads to failure andpost surgical complications.Plastic surgery procedures tend to favor speed and immediatecosmetic results. For these reasons, leaving or "reusing" tissuefrom an existing capsule may seem more "gratifying" However, adverseeffects resulting from the practice are widespread but have not beenwell documented. Typically, patients who require removal of faultyimplants and undergo immediate re-implantation in the sameprosthetic site habitually relapse with the same problem whichmotivated the previous surgery; the most common example is exchangeof implants and/or sectorizing or bisecting the capsule withoutremoving it completely.Such patients rarely achieve a significant capsular correction andhabitually return for more similar surgery. A more illustrativesituation is that where patients do not receive replacementimplants. They form the basis of knowledge for evaluating the risksthat arise from remaining capsules. An example is described in apaper published in 1993 (Copeland, M., Kessel, A., Spiera, H.,Hermann, G., Bleiweiss, I. J.; Systemic Inflammatory DisorderRelated To Fibrous Breast Capsules After Silicone Implant Removal;Plastic and Reconstructive Surgery: 92 (6), 1179-1181, 1993):reported problems derived primarily from immune phenomena andinflammatory syndromes with pain, swelling, serologic abnormaladiesand alarming radiologic presentation.Numerous similar cases have been noted amongst implant patients buthave not been theobject of publications. Some are cited in FDAReaction Reports. Others appear in theU.S. Pharmacopoeia ReportingPrograms.A residual capsule is not a stable entity. It may collapse uponcompletion 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 wallmatures and the breast remodels to accommodate the loss of theprostheses, the capsular tissue shrinks. Water as well aselectrolytes are expelled gradually from the pocket or else themixture is concentrated from leakage of water from the semi-permeable capsular membrane wall.In most cases, calcium salts precipitate during that stage and mayrender the capsule visible as a radiodense and speckled zone inradiographic projections. Prosthetic debris is also radiodense andmay be imaged to further complicate the presentation. The averagesize of the residual capsules after 6-12 months is in the 2-7 cmrange: most are compact, comparatively small and dense. Surgicalremoval should present no difficulty for most patients if adequateradiographic information is available.Later stages of maturation include the thickening of the capsulewall, sometimes reaching 0.5-1cm. Compression of the debris into acluster of nodules which actually become calcified follows for somepatients. A few mimic malignancies. Others appear assmall "prostheses" during mammographic studies. They are alarming toonocologists and are habitually signalled for further studies orbiopsies by oncologic radiologists.In light of the present knowledge and considering the probablecontent of the residual closed capsules, an open or needle biopsy isnot advisable. The risks of releasing significant amounts ofhazardous contamination and possibly spreading infective entitiesoutweighs the advantage of the diagnostic. At any rate, such acapsule requires removal for mitigation of symptoms and a moredirect surgical approach appears more economical and less risky.In summary, a capsule with a dense fibro-collagenous wall behaves asa bioreactor. Worse yet, it is fitted with a semi-permeable wallthat may periodically open to release its content to the breast. Theprobability of finding the space colonized with atypical micro-organisms is elevated and the control of infective processes byclassic 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 thecontent and the age of the structure, its maturity and the historyof the patient. There is a high probability that these capsules willcontinue to evolve for many years, adding more layers of fibro-collagenous tissue and possibly granulomatous material. If bacterialentities are present within the capsule space, they can culminate inlarge breast abscesses with will resist conservative treatments.Even with less active capsules containing mostly oily and calciticdebris, the thickening of the wall leads eventually to solid "tumor-like structures" and are, by themselves, alarming on auscultationand self examination. At best, such structures are uniqueenvironments for protein denaturation and aberrant biochemicalreactions with unknown long term consequences.Pierre Blais, Ph.D.Innoval 496 Westminster Ave.Ottawa, OntarioCanada KeA 2V1Phone: (613) 728-8688Fax: (613) 728-0687Pierre Blais, PhD received his undergraduate and graduate degrees inphysical-organic polymer chemistry from McGill University inMontreal, Canada, and a Post-doctorate Fellowship in biomaterialsengineering at Case Western University in Cleveland, Ohio. In 1976he became one of the first scientists to join the medical devicesand radiological health program of the Department of Health andWelfare in Canada. He left the department in 1989 as SeniorScientific Advisor and formed Innoval Consultants, a firm engaged inthe design, testing and failure analysis of high risk medicalsystems. He has authored over 250 publications on medical materialsand 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)See our photos website! Enter "implants" for access at this link:http://.shutterfly.com/action/

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Here is the article from Dr. Blais, and it is so important for each of us to read this before we have our surgery....love to all...Lea

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This is from our Ilena, this is what I will give to the surgeon tomorrow.Love to all....Lea~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~````` Dr. Blais on Removing Capsules ... VERY IMPORTANT TO READ PRE-EXPLANTResidual Capsule and Intercapsular Debris As Long Term Risk Factors.Contamination of the space between the capsule and the implants bymicro- organisms, silicone oils, degradation products and gelimpurities constitutes a major problem which potentiates the risk ofimplants. Such problems include inflammation, infection, depositionof mineral debris, as well as certain auto-immune phenomena. Theseproblems can be present when implants are in situ (in the body) andare often attributable to the implant. The logical expectation isthat, upon removal of the implants, adverse effects will cease. Thisis an unjustifiably optimistic view. It is well documented from casehistories that removal and or replacement of implants withoutexhaustive debridement of the prosthetic site leads to failure andpost surgical complications.Plastic surgery procedures tend to favor speed and immediatecosmetic results. For these reasons, leaving or "reusing" tissuefrom an existing capsule may seem more "gratifying" However, adverseeffects resulting from the practice are widespread but have not beenwell documented. Typically, patients who require removal of faultyimplants and undergo immediate re-implantation in the sameprosthetic site habitually relapse with the same problem whichmotivated the previous surgery; the most common example is exchangeof implants and/or sectorizing or bisecting the capsule withoutremoving it completely.Such patients rarely achieve a significant capsular correction andhabitually return for more similar surgery. A more illustrativesituation is that where patients do not receive replacementimplants. They form the basis of knowledge for evaluating the risksthat arise from remaining capsules. An example is described in apaper published in 1993 (Copeland, M., Kessel, A., Spiera, H.,Hermann, G., Bleiweiss, I. J.; Systemic Inflammatory DisorderRelated To Fibrous Breast Capsules After Silicone Implant Removal;Plastic and Reconstructive Surgery: 92 (6), 1179-1181, 1993):reported problems derived primarily from immune phenomena andinflammatory syndromes with pain, swelling, serologic abnormaladiesand alarming radiologic presentation.Numerous similar cases have been noted amongst implant patients buthave not been theobject of publications. Some are cited in FDAReaction Reports. Others appear in theU.S. Pharmacopoeia ReportingPrograms.A residual capsule is not a stable entity. It may collapse uponcompletion 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 wallmatures and the breast remodels to accommodate the loss of theprostheses, the capsular tissue shrinks. Water as well aselectrolytes are expelled gradually from the pocket or else themixture is concentrated from leakage of water from the semi-permeable capsular membrane wall.In most cases, calcium salts precipitate during that stage and mayrender the capsule visible as a radiodense and speckled zone inradiographic projections. Prosthetic debris is also radiodense andmay be imaged to further complicate the presentation. The averagesize of the residual capsules after 6-12 months is in the 2-7 cmrange: most are compact, comparatively small and dense. Surgicalremoval should present no difficulty for most patients if adequateradiographic information is available.Later stages of maturation include the thickening of the capsulewall, sometimes reaching 0.5-1cm. Compression of the debris into acluster of nodules which actually become calcified follows for somepatients. A few mimic malignancies. Others appear assmall "prostheses" during mammographic studies. They are alarming toonocologists and are habitually signalled for further studies orbiopsies by oncologic radiologists.In light of the present knowledge and considering the probablecontent of the residual closed capsules, an open or needle biopsy isnot advisable. The risks of releasing significant amounts ofhazardous contamination and possibly spreading infective entitiesoutweighs the advantage of the diagnostic. At any rate, such acapsule requires removal for mitigation of symptoms and a moredirect surgical approach appears more economical and less risky.In summary, a capsule with a dense fibro-collagenous wall behaves asa bioreactor. Worse yet, it is fitted with a semi-permeable wallthat may periodically open to release its content to the breast. Theprobability of finding the space colonized with atypical micro-organisms is elevated and the control of infective processes byclassic 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 thecontent and the age of the structure, its maturity and the historyof the patient. There is a high probability that these capsules willcontinue to evolve for many years, adding more layers of fibro-collagenous tissue and possibly granulomatous material. If bacterialentities are present within the capsule space, they can culminate inlarge breast abscesses with will resist conservative treatments.Even with less active capsules containing mostly oily and calciticdebris, the thickening of the wall leads eventually to solid "tumor-like structures" and are, by themselves, alarming on auscultationand self examination. At best, such structures are uniqueenvironments for protein denaturation and aberrant biochemicalreactions with unknown long term consequences.Pierre Blais, Ph.D.Innoval 496 Westminster Ave.Ottawa, OntarioCanada KeA 2V1Phone: (613) 728-8688Fax: (613) 728-0687Pierre Blais, PhD received his undergraduate and graduate degrees inphysical-organic polymer chemistry from McGill University inMontreal, Canada, and a Post-doctorate Fellowship in biomaterialsengineering at Case Western University in Cleveland, Ohio. In 1976he became one of the first scientists to join the medical devicesand radiological health program of the Department of Health andWelfare in Canada. He left the department in 1989 as SeniorScientific Advisor and formed Innoval Consultants, a firm engaged inthe design, testing and failure analysis of high risk medicalsystems. He has authored over 250 publications on medical materialsand 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)See our photos website! Enter "implants" for access at this link:http://.shutterfly.com/action/

[Guest guest]

Dear Friends:

Here is an article from Dr. Blais, he is a Medical Devises Expert.

Love to all...Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``

Residual Capsule and Intercapsular Debris As Long Term Risk Factors.Contamination of the space between the capsule and the implants bymicro- organisms, silicone oils, degradation products and gelimpurities constitutes a major problem which potentiates the risk ofimplants. Such problems include inflammation, infection, depositionof mineral debris, as well as certain auto-immune phenomena. Theseproblems can be present when implants are in situ (in the body) andare often attributable to the implant. The logical expectation isthat, upon removal of the implants, adverse effects will cease. Thisis an unjustifiably optimistic view. It is well documented from casehistories that removal and or replacement of implants withoutexhaustive debridement of the prosthetic site leads to failure andpost surgical complications.Plastic surgery procedures tend to favor speed and immediatecosmetic results. For these reasons, leaving or "reusing" tissuefrom an existing capsule may seem more "gratifying" However, adverseeffects resulting from the practice are widespread but have not beenwell documented. Typically, patients who require removal of faultyimplants and undergo immediate re-implantation in the sameprosthetic site habitually relapse with the same problem whichmotivated the previous surgery; the most common example is exchangeof implants and/or sectorizing or bisecting the capsule withoutremoving it completely.Such patients rarely achieve a significant capsular correction andhabitually return for more similar surgery. A more illustrativesituation is that where patients do not receive replacementimplants. They form the basis of knowledge for evaluating the risksthat arise from remaining capsules. An example is described in apaper published in 1993 (Copeland, M., Kessel, A., Spiera, H.,Hermann, G., Bleiweiss, I. J.; Systemic Inflammatory DisorderRelated To Fibrous Breast Capsules After Silicone Implant Removal;Plastic and Reconstructive Surgery: 92 (6), 1179-1181, 1993):reported problems derived primarily from immune phenomena andinflammatory syndromes with pain, swelling, serologic abnormaladiesand alarming radiologic presentation.Numerous similar cases have been noted amongst implant patients buthave not been theobject of publications. Some are cited in FDAReaction Reports. Others appear in theU.S. Pharmacopoeia ReportingPrograms.A residual capsule is not a stable entity. It may collapse uponcompletion 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 wallmatures and the breast remodels to accommodate the loss of theprostheses, the capsular tissue shrinks. Water as well aselectrolytes are expelled gradually from the pocket or else themixture is concentrated from leakage of water from the semi-permeable capsular membrane wall.In most cases, calcium salts precipitate during that stage and mayrender the capsule visible as a radiodense and speckled zone inradiographic projections. Prosthetic debris is also radiodense andmay be imaged to further complicate the presentation. The averagesize of the residual capsules after 6-12 months is in the 2-7 cmrange: most are compact, comparatively small and dense. Surgicalremoval should present no difficulty for most patients if adequateradiographic information is available.Later stages of maturation include the thickening of the capsulewall, sometimes reaching 0.5-1cm. Compression of the debris into acluster of nodules which actually become calcified follows for somepatients. A few mimic malignancies. Others appear assmall "prostheses" during mammographic studies. They are alarming toonocologists and are habitually signalled for further studies orbiopsies by oncologic radiologists.In light of the present knowledge and considering the probablecontent of the residual closed capsules, an open or needle biopsy isnot advisable. The risks of releasing significant amounts ofhazardous contamination and possibly spreading infective entitiesoutweighs the advantage of the diagnostic. At any rate, such acapsule requires removal for mitigation of symptoms and a moredirect surgical approach appears more economical and less risky.In summary, a capsule with a dense fibro-collagenous wall behaves asa bioreactor. Worse yet, it is fitted with a semi-permeable wallthat may periodically open to release its content to the breast. Theprobability of finding the space colonized with atypical micro-organisms is elevated and the control of infective processes byclassic 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 thecontent and the age of the structure, its maturity and the historyof the patient. There is a high probability that these capsules willcontinue to evolve for many years, adding more layers of fibro-collagenous tissue and possibly granulomatous material. If bacterialentities are present within the capsule space, they can culminate inlarge breast abscesses with will resist conservative treatments.Even with less active capsules containing mostly oily and calciticdebris, the thickening of the wall leads eventually to solid "tumor-like structures" and are, by themselves, alarming on auscultationand self examination. At best, such structures are uniqueenvironments for protein denaturation and aberrant biochemicalreactions with unknown long term consequences.Pierre Blais, Ph.D.Innoval 496 Westminster Ave.Ottawa, OntarioCanada KeA 2V1Phone: (613) 728-8688Fax: (613) 728-0687Pierre Blais, PhD received his undergraduate and graduate degrees inphysical-organic polymer chemistry from McGill University inMontreal, Canada, and a Post-doctorate Fellowship in biomaterialsengineering at Case Western University in Cleveland, Ohio. In 1976he became one of the first scientists to join the medical devicesand radiological health program of the Department of Health andWelfare in Canada. He left the department in 1989 as SeniorScientific Advisor and formed Innoval Consultants, a firm engaged inthe design, testing and failure analysis of high risk medicalsystems. He has authored over 250 publications on medical materialsand 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)See our photos website! Enter "implants" for access at this link:http://.shutterfly.com/action/

[Guest guest]

Lea ~

Thank you for sharing this, all the new girls

need to know this very important information !

Love you ~

Dede

Fw: Dr. Blais on Removing Capsules ... VERY IMPORTANT TO READ PRE-EXPLANT

Dear Friends:

Here is an article from Dr. Blais, he is a Medical Devises Expert.

Love to all...Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~``

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)

See our photos website! Enter "implants" for access at this link:

http://.shutterfly.com/action/