necessity of en bloc w/saline implants.....Dr Blias

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Dr Pierre Blias on Residual Capsule

http://www.info-implants.com/pierre.html

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. Start the year off right. Easy ways to stay in shape in the new year.