Mammary prostheses and their associated surgical procedures are associated with morbidity and health care costs. There is a wide spectrum of injuries ranging from the benign to the very serious. Some injuries are direct consequences prosthetic system failure resulting in release of tissue-incompatible substances . Others result from mechanical, physicochemical and microbiological processes which take place in the space between the implants and the surrounding tissue capsules. Still others are sequelae of surgical misadventures. Sometimes it is a combination of all factors and it is necessary to review medical files to understand the relative impact of each of the factors. There are important variations amongst patients which make some more vulnerable than others to this technology.

Apparent anomalies are also found. In some cases, prostheses are removed and, to the eye of the surgeon or the pathologist, the devices appear superficially "intact" or "unchanged". Detailed examination of such explants nevertheless show significant chemical changes with potential for major adverse health impact through classical toxicology mechanisms.

Breast prostheses are not made to the same level of quality as other long term implants. They are low cost products manufactured in large volumes and with considerable variations from batch to batch. The technology embodied in the products precludes uniformity. At any rate, the cosmetic surgery products industry has not historically been noted for sophistication in research and production techniques. As a result, this class of medical products lacks the durability, quality, safety and efficacy expected of modern health care devices.

Breast implants and related products habitually undergo deep changes. They also initiate changes in the surrounding tissue, sometimes by absorbing and converting natural biological substances from the host into modified products with adverse health implications to the user. This process takes place in the intracapsular space and within folds of the shell which entrap tissue and proteinaceous fluids.

Capsules which form around the prostheses are decisive factors in initiating and maintaining a disease condition. This is why surgical centers with experience of medical removal advise patients to have this tissue excised. Some surgeons elect not to perform this procedure or else do it only in part. It is frequent to have such patients with capsule residuals return for surgery within one to three years in order to retrieve this material and its associated debris in the hope of resolving continuing health problems. Patients who have undergone multiple replacement of implants or who have encountered immediate post-surgical problems are particularly vulnerable to such effects.

Many patients are in this situation and tend to be left puzzled as to what has affected them during the time they had the devices in place. There are numerous explanations for problems encountered by breast prosthetic patients. Some are the result of force fitting a device of a significant size in a space that was never designed to contain it. Others are more complex and have to do with pharmacological and immunological effects that take place in the space between the implant and its surrounding artificIally-created tissue capsule.

In summary, most patients who have been subjected to more than a few years of implant usage tend to be injured from a multiplicity of factors, some which relate directly to the implant but where most have suffered greater impact from capsule-related phenomena or mechano-anatomic dysfunction associated with interference of the large foreign object with essential functional structures in the vicinity of the upper chest. Biochemical effects associated with the incubation of stagnant, contaminated fluids surrounding large implants can also be dominant factors that overwhelm simpler toxicological phenomena induced by bioavailable impurities from the implant constituents .

Mammary prostheses and their associated surgical procedures are associated with morbidity and health care costs. There is a wide spectrum of injuries ranging from benign to very serious. Some injuries are direct consequences of prosthetic system failure resulting in release of tissue-incompatible substances. Others result from mechanical, physicochemical and microbiological processes which take place in the space between the implants and the surrounding tissue capsules. Still others are sequelae of surgical misadventures which affect the boundary between the implant and the capsule; infective processes and accumulation of fluids such as hematomas and seromas are common in this context. Sometimes it is a combination of all factors and it is necessary to review medical files to understand the relative impact of each of the factors. There are important variations amongst patients which make some more vulnerable than others to this technology.

Breast prostheses are not made to the same level of quality as other long term implants. They are low cost products manufactured in large volumes and with considerable variations from batch to batch. The finished products bear large quantities of surface impurities and release even more during the early dwell time. They are deemed ‘low purity’ systems. The technology embodied in the products precludes uniformity and the cosmetic surgery products industry has not historically supported or demanded the same level of quality that is generally expected of implantable medical products.

Breast implants and related products habitually undergo deep physico-chemical changes after implantation. They also cause changes in the surrounding tissue, sometimes by absorbing and converting natural biological substances from the host into modified products with adverse health implications to the user. This process takes place in the intracapsular space and within folds of the shell which entrap tissue and proteinaceous fluids.

Dense capsules which form around the prostheses are decisive factors in initiating and maintaining a disease condition. This is why surgical centers with experience of medical removal advise patients to have this tissue excised. Some surgeons elect not to perform this procedure or else do it only in part. Users of fixation type implants present particularly difficult removal problems and exhaustive debridement of contaminated periprosthetic tissue is particularly difficult. Many dissection procedures performed on implant users employ electrosurgical devices. The electrosurgical dissection of tissue leaves significant residuals. These are combustion products which include oxidized alloplastic substances and carbonized plastic fragments. Such materials are later found within the capsules and appear more inflammatory than unaltered prosthetic debris. Individuals who undergo replacement of prostheses without removal of the primary capsules and other users with capsule residuals frequently return for surgery within 1-3 years in order to retrieve this material and its associated debris in the hope of resolving continuing health problems. Users who have undergone multiple replacement of implants or who have encountered immediate post-surgical problems are particularly vulnerable to intracapsular effects.

The space between the capsule and the implant is not a void. Even under ideal conditions, it is habitually filled with a film of serous fluid. Early perceptions on implant behavior surmised that this fluid as well as the fluid within the implants contributed to the longevity of the shells as it served to ‘lubricate’ the interface thus delaying failure through pleat folding and surface erosion.

The composition of this medium changes as the implant ages. It becomes more abrasive with time as solids mineralize. If there are complications such as inflammation or infiltration of blood into the intracapsular space the volume of stagnant fluid is significantly more. Comfort and aesthetic problems sometimes become decisive factors motivating users to seek additional corrective surgery. Extreme cases where large hematomas develop, in particular when ruptures are suspected. These sites sometimes produces as much as several hundred milliliters of extracellular fluid mixed with blood cells, proteins, micro-organisms, partly dispersed prosthetic material including impurities of low molecular weight silicone derivatives.

The intracapsular fluid mixtures vary from very mobile, water-like and nearly without color, to thick, paste-like media with intense amber colorations. White pasty fluids are most common for users of devices that have been in situ for more than 6-7 years. The space always contains large quantities of emulsified oils and detergent-like substances which are formed through biodeterioration of blood products. When micro-organisms populate the site, overt infections do not always result. The most common micro-organisms do not culminate in florid infective manifestations. Instead, colonies form and are comparatively well tolerated by the host. Microbiological activity proceeds and metabolites formed by the entities become part of the toxic burden produced by the intracapsular medium.

Textured prostheses habitually become laden with blood as a result of the surgery. Coagulation takes place in contact with the surface with immobilization of blood through deposition of fibrin. If small amounts of additional blood continue to seep into the capsule space after completion of the surgery, fibrin deposits in large quantities into the area. Reorganization of this material leads to tissue precursors in the form of pannus and fine tissue particles. Free collagen fibrils are most common in these mixtures. Reorganized blood products adhere to porous surfaces which in turn detach through friction and movement causing larger pieces to float free within the intracapsular space. Large amounts of such material are released when the surface begins to disintegrates and erode several months after implantation.

Ultimately, separate internal ‘capsules’ develop and mechanical action on the weak friable tissue structures contributes to further disaggregation and dispersal of debris within the capsule. After several months in situ and in the presence of accumulated fluid, the tissue breaks up into finer particles which resemble a colored paste. The substance is rich in chemical derivatives from oils and contain large quantities of hemosiderin, the primary degradation product of hemoglobin. Focal siderosis becomes evident in adjacent tissue with marked uptake of colored entities and focal inflammation. Thus, the intracapsular site is an ideal situation for formation of unusual bioactive substances which contribute to local and systemic effects, some of which become evident soon after surgery.

With time, many users develop radiographically discernible layers of fluid between the prostheses and the surrounding capsules. Most users with prostheses exceeding 4-5 years of dwell time show such distinct radiolucent zones between the prostheses and the surrounding tissue. For individuals with organized intracapsular hematomas and seromas, the space is much larger and its presentation is readily ascertained, even with low quality mammographic equipment. For users with post-implantation hematomas a distinct zone may remain for many years after evacuation of the hematoma. Later, there is often preferential calcification of such sites. This introduces additional mammographic artifacts. Late formation of radiodense pockets containing scattered and punctuated mineralized structures derived from organized hematomas and seromas have been observed in users with dwell times exceeding 10-12 years.

Many users of "intact" implants are puzzled as to what has affected them during the time they had the devices in place. There are numerous explanations for problems encountered by breast prosthetic patients. Some are the result of force-fitting a device of a significant size in a space that was never designed to contain it. Others are more complex and have to do with pharmacological and immunological effects that take place in the space between the implant and its surrounding artificIally-created tissue capsule.

In summary, most users who have been subjected to more than a few years of implant usage tend to be injured from a multiplicity of factors, some which relate directly to the implant but where most have suffered greater impact from capsule-related phenomena or mechano-anatomic dysfunction associated with interference of the large foreign object with essential functional structures in the vicinity of the upper chest in an environment containing large quantities of bioactive substances and where micro-organisms are habitually found.