Date: Sun, 8 Apr 2001 22:32:32 -0700

I.A.S. IMPLANT AWARENESS SOCIETY

102 - 6086 Boundary Drive West

Surrey, B.C., Canada V3X 2B3

Telephone: (604) 572-8486

Dear Silicone Sisters,

The following message came to us over the Internet. I have many questions about what other people have heard or experienced about textured implants. Is the fungus caused from the saline or silicone or does the textured surface itself cause fungus or some sort of inflammation that just lingers on even after explant? How long does the itching and burning usually last? Any information would be appreciated.

Comments have been added after Dr. Pierre Blais' answer to these and other questions.

Textured surfaces figure prominently amongst the history of breast augmentation devices. Their popularity is credited to W.J. Pangman who, in the 1960s, suggested that a rough surface would have a greater ability to attach itself on a slippery tissue surface. He reasoned that tissue would grow into the irregularities causing the implant to lock in place and become an integral part of its surroundings, a situation that he perceived as desirable with a device used for increasing breast size. This concept, termed _tissue fixation had been borrowed from vascular, cardiac, and abdominal wall repair surgery where implants made of porous fabric had been successfully employed for many years. For example, woven fabric tubes were widely used to replace large arteries. The fabric would become, with time, coated with new tissue that rendered the structures impermeable and permanently integrated into natural vasculature through fibrosis. The open fabrics induced the rapid formation of thick, smooth connective tissue termed pannus. Rough metal surfaces were also used in orthopaedic implants to induce bone ingrowth, causing parts that required strength and stability, such as hip and knee implant components to lock into adjacent bone.

The belief that immobilization of a breast implant against the chest wall or surrounding tissue became entrenched in plastic surgery and pervaded breast implant designs in the sixties and seventies. Porous tissue fixation parts or textured coatings were incorporated in nearly all early breast implants, such as the Cronin, the Pangman-Wallace, the New Polyplastic, the Ashley Natural-Y, and many others. By the seventies, serious problems associated with tissue fixation were well known. It took another decade to abandon the concept. Only polyurethane foam-covered breast prostheses remained as anachronistic examples of tissue fixation devices. They were the Ashley Natural-Y implants and their successors, such as the Vogue, Optimam, Meme, and Replicon.

These foam-coated devices were all initially predicated on the principle of tissue fixation. This would have been a reasonable assumption had the textured surface remained unaltered during the lifetime of the device. However, as reported by many surgeons and pathologists, this was not the case. The foam coating disintegrated and disappeared thus invalidating claims that fixation served any beneficial purpose. The promoters of foam implants later asserted that polyurethane foam-covered devices had resorbable and bioactive coatings that reduced their propensity to suffer capsular contracture. This claim was ill founded. The only definitive finding is that these devices soon lost their coatings that disintegrated and scattered into the surrounding breast tissue, frequently inducing severe adverse effects, including contracture.

The concept of rough-surfaced implants was reintroduced in the mid-80s by other manufacturers who sought to duplicate the texture of polyurethane without the risks of dissolution and disintegration. Textured products were investigated by American Heyer Schulte (AHS) in the mid-70s and led to other types of polyurethane foam-covered devices and implants textured through the temporary imprinting of textures through contact with foam surfaces. These were later abandoned because of fabrication problems and the uncharacterized toxicology of the adhesive and elastomers necessary for implementing the texturing.

Early commercial examples of textured-surface implants using direct texturing processes investigated by AHS were followed by other products made by the successor corporation. They include the Mentor Corporation SiltexTM breast implant lines introduced circa 1985. The SiltexTM shells made use of rough texturing molds to generate fine replicated irregularities on the surface of otherwise conventional prostheses. McGhan/Inamed introduced competing BiocellTM lines, a class of device made by casting a finished film of silicone elastomer on top of a conventional shell and then contaminating this layer with water-soluble particles. The soluble particles would then be redissolved in water to produce an irregular, vacuolated surface.

The BiocellTM texturing process was accident-prone. The requirements for a soluble sacrificial substance to create holes into a cast surface had a tendency to leave closed cell surfaces. Upon aggressive washing, the sacrificial material would eventually dissolve but the residual cavities would be nearly impossible to clean. The process produces frangible surfaces that readily spallated debris into the adjacent tissue. The closed cells and the poor permeability of the surfaces would facilitate growth of bacteria and aberrant denaturation of tissue within enclosed spaces. When infection occurred at the prosthesis-tissue interface, the problem was uncontrollable and self-propagating. The rough surface had a tendency to form a separate layer of pannus that formed on the texture and yet remained discrete from the outer capsule. This pannus would have its own contractile characteristics and friction between this surface and the outer capsule caused continuous communication of tissue in fine fragments that scattered throughout the intracapsular space. The surgical removal of coarsely texture surface implants also presented problems. Many users developed thick, complex multilayered capsules bound to the prosthesis surface through interdigitation. Removal becomes difficult after 24-36 months, in particular if there are residual capsule fragments from earlier prostheses.

The only novel technology that appeared in the late-1980s was that of Dow Corning with microtextured implant surfaces consisting of microscopic columnar elements created through direct molding processes. Molds made by laser micromachining the surface to create fine, deep, closely spaced cavities were employed. These devices were costly to make. Because the molded microtextured element was very small and many were needed, the process for mold making was laborious and erratic. It required the creation of very small holes to produce a plastic surface with fine columns of polymer with average diameters below 0.05 mm. This is not feasible with precision machine tools. It requires lasers. The lasers produce burnt polymer surfaces that released crumbly, degradable mold debris. The fine holes had a tendency to occlude debris. After several cycles of use, cleaning could not be performed exhaustively, and the holes collected adventitious impurities and viable microorganisms. The service life of the molds was short and reconditioning was costly.

In the final analysis, the ability of these systems to reduce contracture is illusory. Texture is not a major benefit. Worse, it often facilitated contamination. Classical and sub-clinical infections are common and often lead to rapid contracture. Texturing further reduces the already poor rate of long-term success of breast implant surgery. At its worst, it is an additional risk factor because of the ability of porous surfaces to harbor and protect microorganisms.

Upon reading Dr. Blais' text above, we painfully learn that textured breast implants are more problematic than the smooth shell. This is why so many women say after implantation that it is too painful to reach up or out with their arms, especially if the implant is under the muscle. The tissue ingrowth can be so severe that it causes muscle shredding. The saline fluid inside the breast has a shelf life, and no hospital will wash a scratch with outdated saline. It becomes septic in less than two years time. The closed cells and the poor permeability of the surfaces would facilitate growth of bacteria and aberrant denaturation of tissue within enclosed spaces. When infection occurred at the prosthesis-tissue, the problem was uncontrollable and self-propagating. These facts explain why there is itching, burning, and inflammation even after explant.

Some infection from breast implants are similar to a gunshot wound in battle, there is no cure for the induced infection. Dr. Blais says repeatedly that breast implantation is a greater wound than many gunshot wounds in battle. Dr. Blais explains why the textured implants are almost impossible to completely explant leaving debris behind that no medication will help.

The sad truth is, what is on the breast implant insert information packet from the manufacturer is almost completely opposite to what takes place in the woman 's body. Dr. Blais has about 200 pairs of textured breast implants that he has tested. He carefully records all of the information of the implant, even to the packet insert that has in his words wonderful wool-spin messages on them.

Enquiries are invited,

Adella Matthew