Implant Veterans of Toxic Exposure

Dr. Pierre Blais

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RESIDUAL CAPSULE AND INTERCAPSULAR DEBRIS AS LONG-TERM RISK FACTORS

By: Dr. Pierre Blais, PhD

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 potentates the risk of implants. Such problems 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 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 abnormalities and alarming radiologic presentation.

Numerous similar cases have been noted amongst implant patients but have not been the object of publications. Some are cited in FDA Reaction Reports. 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 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 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 for further studies or biopsies by oncologic radiologists.

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