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RESIDUAL AND INTERCAPSULAR DEBRISAS LONG-TERM RISK FACTORS By: Dr. Pierre Blais, PhDContamination of the space between the capsule and the implants by

micro- organisms, silicone oils, degradation products and gel impuritiesconstitutes a major problem which potentates the risk of implants. Suchproblems include inflammation, infection, deposition of mineral debris,

as well as certain autoimmune 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 procedure lead to favor speed and immediate cosmeticresults. For these reasons, leaving or "reusing" tissue from an existingcapsule may seem more "gratifying". However, adverse effects resulting

fromthe 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; Plasticand Reconstructive Surgery: 92 (6), 1179-1181, 1993):

reported problems derived primarily from immune phenomena and inflammatory

syndromes with pain, swelling, serologic abnormalities and alarming radiologic

presentation.Numerous similar cases have been noted amongst implant patients buthave not been the object of publications. Some are cited in FDA ReactionReports. Others appear in the US 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 extra cellular 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 ofthe 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 thecapsule visible as a radiodense and speckled zone in

radiographic projections.Prosthetic debris is also radiodense and

may be imaged to further complicatethe 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 adequateradiographic

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

ofnodules which actually become calcifies follows for some patients.

A few mimic malignancies. Others appear as small "prostheses" during

mammographic studies. They are alarming to oncologists and are

habitually signaled forfurther studies or biopsies by oncologic radiologists.In light of the present knowledge and considering the probable contentof the residual closed capsules, an open or needle biopsy is not advisable.The risks of releasing significant amounts of hazardous contamination andpossibly 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 abioreactor. Worse yet, it is fitted with a semi-permeable wall that mayperiodically open to release its content to the breast. The probability offinding the space colonized with atypical microorganisms is elevated and

the control of infective processes by classic pharmacologic approaches isdifficult 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 withwill 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, PhDInnoval, 496 Westminster Ave., Ottawa, Ontario, Canada K2A 2V1613.728-8688, Fax: 613.728-0687Pierre Blais, PhD received his undergraduate and graduate degrees in

physical-organic polymer chemistry from McGill University in Montreal,

Canada, and a Postdoctorate 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 he

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.