Breast Implants A Review

Acta chir belg, 2004, 104, 158-165 Breast Implants A Review D. Van Zele, O. Heymans Department of Plastic, Reconstructive & Aesthetic surgery, Surgery of the hand and Burncenter, University Hospital Sart Tilman, Liège, Belgium. Key words. History ; review ; breast implant ; breast prosthesis ; silicone ; saline ; complications. Abstract. Breast implants have been used for about four decades for both reconstructive and aesthetic purposes. In 1963, the quality of the artificial implants was revolutionized by the introduction of the silicone gel-filled implant. Since, this modern prosthesis has gone through an evolution of change and improvement with several types of devices with many variations and styles within each class. Actually, for the last three decades, approximately one million women have received silicone breast implants in the USA. But, in 1992, the American FDA banned silicone from the market, leaving saline implants as the only product generally available as an alternative until now. Other filler materials were introduced, but have never progressed beyond the experimental stage in the USA (in contrast with Europe). The evolution of the different implants through time, with their advantages and disadvantages will be discussed, but also the controversy on silicone implants in the USA and their suspected association with systemic diseases. Review In 1854, VELPEAU was the first surgeon who described in his essay Traité des maladies de sein et de la region mammaire techniques which modified and corrected altered shapes and sizes of the breast. GERSUNY proposed, in 1889, local paraffin injections to increase the volume of the breast. Although previously, a cosmetic amelioration could be noted, on he long run numerous complications appeared as solid massesgranulomas, cutaneous erosion and cutaneous fistulas, migration, blindness or pulmonary embolism. In 1895, CZERNY described a successful transplantation of a lipoma, which had the size of a fist, from the back into a breast after excision of a fibro adenoma, and this for pure aesthetic purposes. Other autologous materials like dermis grafts and fatdermis grafts (taken from the gluteal folds) were examined for their potential by E. LEXER in 1925 and by BERSON in 1944, but the results appeared to be too unpredictable, with atrophy noted up to 50%. Giant calcifications and cysts of fat necrosis were frequently observed (1). In the fifties, the injection of liquid silicone appeared and was performed for augmentation of the breast and facial contours. At that time, surgeons thought that silicone was a completely inert substance with the advantage that its consistence approached that of normal breast tissue. In many cases though, non medical-grade silicone was used, under dubious conditions. Eventually, as was noticed before with the paraffin injections, important complications occurred such as hard, painful nodules and/or inflammation. These phenomena could be that serious that the only solution to the problem was a SC mastectomy to relieve the patient! (2-4). It is still performed in some Asian countries. In the past, implants made of ivory or glass have been unsuccessfully utilized. Since 1951, an increasing number of plastic surgeons became interested in the use of implants for augmentation mammaplasty, when PANGMANN introduced a sponge-like implant made of polyvinyl alcohol (PVA) (5-6). The goal of this spongy structure was to promote integration of the implant into the surrounding breast tissue by growth into the pores of the sponge. But what was thought to be an advantage, appeared to be a disadvantage because incrustation and scar retraction reduced the volume and softness of the implant. Calcification and asymmetry were frequently seen and sometimes the implant contracted into a rock-hard formation. So, the implant was modified and the sponge encapsulated in a polyethylene sac. This sac was supposed to block the infiltration and thus prevent the complications mentioned above. But nevertheless, the same problems appeared because of the non- water tightness of the envelope.

Breast Implants 159 In the sixties, the quality of the artificial implants was improved to a degree that rendered these acceptable as a method of treatment. The design of the implant was revolutionized by T. CRONIN and F. GEROW (7). They presented their experience with a new round implant. They wrapped a smooth and thin envelope of rubbery silicone elastomer (polysiloxisanes) around a soft but firm silicone-gel compound (Fig. 1). Silicone is one of the least bioreactive materials used in medical devices. It is used in tracheotomy tubes, the coating of surgical needles, suture thread or pacemakers, heart valves, facial implants for birth defects, artificial lenses for the eyes, CSF shunts, artificial joints or catheters. Compared to the already existing implants, these new implants conserved better their form, softness and also provoked less local tissue reaction. Quickly this natural feel Silastic gel prosthesis conquered the whole world and became the implant of choice and the golden standard. In 1968, DEMPSEY and LATHAM proposed a submuscular- retropectoral-implantation of the implant in order to diminish capsular formation and/or breast shape changes (8). This technique reduced the capsular contracture rate from 40% to 5%. A year later, Cronin and GEROW modified the design of the implant by making the envelope thinner and stronger and redesigning the shape to a tear drop, resembling a normal looking breast (9). In addition, Dacron patches were integrated on the posterior side of the implants in the hope it would stabilize its position by the integration of these patches to the pectoralis fascia. A few years later, it was found that this tear dropshaped Dacron-backed prosthesis reacted unfavourably to any tendency to capsular contracture. For this reason thin-walled discoid non-backed prostheses progressively became the favoured shape and design. Fig. 2 Development of capsular contracture bilaterally following breast augmentation resulting in breast firmness and implant malposition. In the seventies, animal research done on the implantation of synthetic materials in living tissue showed that a textured implant surface lowered the capsular contracture incidence around the implant (Fig. 2). ASHLEY described a new textured gel-filled implant with a polyurethane foam coating the silicone shell (10). Although the coating was originally planned as a fixation layer, this foam cover resulted in decreased capsular contracture (2-15% when placed sub-glandularly compared to 20-59% when smooth implants are used) and remained soft more consistently than the smooth surface implant (fibroblast proliferation into the polyurethane in many directions) (11). But other studies showed that the polyurethane would degrade and release 2-toluene diamine (TDA), a breakdown product that was known to cause hepatomas in highly cancer-prone rats when fed with high-dose TDA (12, 13). Fig. 1 Smooth silicone-filled prosthesis Fig. 3 Close up view of the textured surface of a breast implant

160 D. Van Zele and O. Heymans The manufacturer voluntarily withdrew the polyurethane-coated implants from the market in 1991, although TDA never has been documented to be a human carcinogen nor was there evidence of TDA being formed in vivo from polyurethane. Actually, these charges have proved to be unfounded! In the early 80 s, new formulations of the shell became available that were stronger and minimized the bleed or diffusion of what is usually tiny amounts of the silicone oil fraction of the gel contents. These newer barrier coat devices, also called lowbleed implants, bleed as little as 1 :10 the rate of the older models. H. BECKER introduced a permanent inflatable implant to augment the breast for aesthetic reasons in the early eighties (14-15). The technique was an improvement compared to that previously described by RADOVAN, in 1978, in which a temporary tissue expander needed to be replaced with a permanent implant (16). The advantages of this kind of implant were a shorter scar and the possibility to adjust the volume peroperatively and postoperatively to obtain a perfect symmetry. A variation of the inflatable implant is brought by the double lumen implant, first introduced by J. HARTLEY in 1973, which is generally constructed with an inner silicone-filled elastomer bag and an outer saline-filled bag. The reverse configuration also exists and is mostly used as a tissue expander after mastectomy. Because the implant surface morphology appeared to be the determining factor of the importance of periprosthetic contracture (which was noticed using the polyurethane-coated implants), research was oriented towards the fabrication of textured envelopes that avoided the long-term doubted surfaced to textured-surfaced envelopes, which seem to minimize the incidence of unwanted firmness from capsular contracture (16-21) (Fig. 3). In 1990, the implant with an anatomical shape, based on the teardrop design introduced by CRONIN and GEROW was reintroduced. This design was inspired by the natural form of the breast and was supposed to bring a better aesthetic result to the upper pole of the breast, which is often too full when round implants are used. January, the 6th 1992, the FDA Administration Commissioner D. KESSLER mandated a temporary moratorium on the use of silicone gel implants.. Manufacturers of implants should provide additional evidence to the already existing one to prove their safety (many studies in the early literature had already concluded that some local complications could occur, and safety studies already suggested no systemic toxicity in animals). The General and Plastic Surgery Devices Panel recommended that the further use of implants should be limited for reconstruction only, that women receiving the implants participate in scientific protocols and that epidemiological studies be conducted to assess the risk of auto-immune diseases. Their decision did not apply to saline-filled implants, although many of the local complications of gel-filled implants were also associated with saline implants. The latter were permitted to remain on the market unrestrictely for both reconstruction and augmentation. The FDA considered saline-filled implants less risky, because although they have the same silicone rubber envelope as gel-filled implants, leakage or rupture would release only salt water, not silicone gel, into the body. How did it get so far? In 1977, a Houston attorney, R. MITHOFF, won the first lawsuit for a Cleveland woman who claimed that her ruptured implants and subsequent operations had caused pain and suffering. She received a $170.000 settlement from the Dow Corning Company. In the beginning of the 80 s The Public Citizen Research Group sent out warning signals that silicone implants could cause cancer in women. At that time, only a dozen isolated case reports in medical literature were published about the possible association of silicone implants and the induction of illnesses. Consequently, these reports were followed by the publication of some case series which received a rush of publicity. This made the FDA decide, in 1988, to reclassify the silicone breast implants into a Class III category which required manufacturers to prove their safety in order to keep their products on the market. Valid scientific data would be evaluated. The questions on implant safety exploded nationally in 1990 when a talk show Face-to-face with Connie Chung detailed the horrors of breast implants. Her report sparked a wave of concern among women with implants and increased pressure on government officials to act. The FDA called a halt to the use of silicone gelfilled implants in January, the 6th of 1992. This led the way for a variety of litigation and class action lawsuits against implant manufacturers, before sufficient scientific data were gathered to prove or disprove the symptoms attributed to implants. Almost every disease and symptom complex from scleroderma to chronic fatigue syndrome to multiple sclerosis and amyotrophic lateral sclerosis have been blamed on the breast implant (22). In 1994 already 19092 individual lawsuits have been filed against the Dow Corning Company, compared to 3558 two years before. The company is facing bankrupt, with 20000

Breast Implants 161 lawsuits and about 410.000 potential claims having been filed in the global settlement. In that same year, a Mayo Clinic epidemiological study is published in the New England Journal of Medicine, which found no increased risk of connective tissue disease and other disorders studied in women with silicone implants (23). The American College of Rheumatology came also to the conclusion, in 1995, that implants did not cause systemic diseases (24). The American Academy of Neurology reviewed, in 1997, existing silicone implant studies and reported that the existing research showed no link between silicone implants and neurological disorders (25). The Journal of National Cancer Institute published a review of scores of medical studies concluding that breast implants did not cause cancer (26). The Institute of Medicine of the National Academy of Sciences released its final report after a 2-year investigation on the possible involvement of silicone implants in systemic or connective tissue diseases as lupus, cancer and scleroderma (27). In that report, it is clearly stated that there is no causal relationship between silicone implants and systemic diseases. Furthermore, an increase in recurrent breast cancer could NOT be proven, some of the studies reviewed even suggest lower rates of breast cancer in implanted women (28). In 2000, JANOWSKY et al. published the results of their metaanalysis of the relationship between silicone implants and the risk of connective tissue diseases in the New England Journal of Medicine (29). They analysed the results of 20 major studies on this subject but could not find evidence of an association between breast implants. Today, the silicone gel-filled implants remain off the market in the USA pending manufacturer safety studies and this at least until 2005. What are the forces driving the implant controversy despite of the weight of scientific evidence (12) : A. The media (shows, magazines, hysterical behaviour) This type of press has created an undue amount of anxiety in many women, which in turn has provoked litigious behaviour and inappropriate demands for explant surgery! B. Class Action Plaintiffs attorneys The suing of implant manufacturers became a boom industry in the US $10 million or more may be owed to you!!, with some lawyers out to convince women that even though they may feel just fine, they are really sick and must be properly compensated. C. Radical Feminist Activist Groups It was their opinion that the preference for big breasts represented female oppression! And if preferring large breasts was oppression, then the implants used to enlarge one s breasts are tools of oppression. After having finished this special topic on silicone implants, we will continue and pick up the thread in 1992. Since the ban in that same year on silicone gel implants, research has been conducted to find a suitable substitute. Implants with a silicone elastomer shell containing normal saline have been used as an alternative. Salinefilled implants have been introduced for the first time by ARION in 1965, but since then they comprised only 10% of the implants placed (30). The controversy on the safety of silicone implants has led to a spectacular increase of the use of saline-filled implants in the USA (10% à 95%) because saline is wholly harmless and if the silicone elastomer ruptures, the saline solution is rapidly absorbed by the surrounding tissues. They also had the advantage of being harmless and also resulted in very low capsular contracture rates, especially when placed behind the pectoralis muscle (1-6%) (20, 31-35). But, on the other hand, they have a less natural appearance (folds, consistence) and an incidence rate of deflation of 1-16% (20, 31, 36) They are actually available in round or contoured shapes and textured or smooth shells, single or double lumen. The double lumen implants are generally constructed with an inner silicone-filled elastomer bag and an outer saline-filled bag. The reverse configuration also exists and is mostly used as a tissue expander after mastectomy. There are several valve types : anterior diaphragm, posterior leaf, or postoperative adjustable valves. As already mentioned, substances as oils (peanut / triglycerids / soybean - Trilucent ) and hydrogels (Biooncotic gel) (36) were also presented as alternatives but these potential substitutes have not progressed yet beyond the experimental stage in the USA. Oils have excellent radiolucency and their consistency approach that one of the breast. On the contrary, their biocompatibility is questionable (if the implant were to break, oil would be dispersed in a multitude of immersible droplets because oil is hydrophobic and not readily soluble. It may clog lymphatics and macrophages for weeks or months until it might be dispersed), bacteria may grow in some vegetable oils and oxygen transmission across the shell may in time cause degradation of oils or fats. In the United Kingdom, more than 5000 women had been implanted with the Trilucent implant between 1995 and 1999 (37-39). In June 2000, the MDA (Medical Device Agency) issued a hazard notice recommending that all women who had been implanted with Trilucent implants, which were sold in the UK between 1995 and 1999, consider having their implants removed as a precautionary measure and that until those implants can be removed, women should not conceive or breastfeed.

162 D. Van Zele and O. Heymans Toxicological preliminary data suggested that genotoxic products as aldehyde products (n-alkanals) may be created when the soybean breaks down. (diffusion/rupture) : based on current scientific knowledge, there is no reason to think that such risk exists (12). A recent series on explanted Trilucent breast implants confirmed the suspicion that a high percentage of these implants bleed, 34% in this series! Patients may be asymptomatic, or they may present with rippling if they have moderate bleed, or with implant deflation when the oil leak is significant enough to manifest as volume loss (40). The rate of significant capsular contracture (Baker 3-4) was approximately as high as 45% (41). The hydrogel-filled implant has a textured surface and is pre-filled with polyvinylpyrrolidone (PVP) hydrogel or bio-oncotic gel. Hydrogel has better lubricating properties than saline, some increased viscosity and does not harbour bacteria (42). On the contrary, a recent series concluded that the MISTI Gold implants did not fully fill the criteria of safe implants. This was based on the findings that 59% of the implants placed, were removed after 4 years. The main reason for the removal was an increase in volume of 38%, followed by capsular contracture in 17% (43). Other potential fillers as air or even breast tissue were tried but abandoned. Cohesive silicone gel is the latest filler innovation on the market (not in the USA) (44). Cohesive gel was already used in anatomical implants, but are recently also available in round implants. The advantages of cohesive gel implants are primarily that they provide a proportionate sized breast augmentation with a very soft and natural-feeling breast implant. The implant maintains its shape in an upright position (has a memory ) which decreases the incidence of folding of the implant shell and the development of rippling. If a cohesive gel implant ruptures, it maintains both its shape and integrity. As well, there are nine models of anatomical cohesive gel implants which vary with respect to height, projection and base width. This provides flexibility for the patient and surgeon in determining the appropriate implant to balance body proportions and breast aesthetics. One disadvantage of cohesive gel implants is that they require a slightly larger incision for insertion. Because of this, insertion is usually performed through an incision in the fold under the breast or occasionally through an incision around the areola. Cohesive gel implants are very difficult to insert through an incision in the armpit. This large diversity of implants also means that none of these implants is perfect. Today, the possible complications that might occur after a breast augmentation are still the same as before ; with that difference that their frequency diminished. In contrast to the use of breast implants for purely aesthetic purposes (Fig. 4, 5), they are also routinely used for breast reconstruction after a mastectomy for breast cancer. A variety of reconstructive techniques exist and the choice of the technique depends both on the present local tissue conditions of the breast and the surgeon s preference. In general, the reconstruction of the breast is performed as a delayed procedure and is not done immediately after the mastectomy in a single operation. In selected cases though (very small tumours, prophylactic breast ablation, excellent local tissue conditions), an immediate reconstruction is possible, using a definitive breast prosthesis or a inflatable expander, which will be filled postoperatively with a saline solution. This expander can be temporary or definitive, depending on the surgeon s preference. In case of a temporary expansion, a second intervention is planned a few months after the first one : the expander is replaced by a definitive implant and more preferably an anatomical shaped textured gel-filled prosthesis. This gel-filled prosthesis is exactly the same as the one used for aesthetical breast augmentation. The advantages and disadvantages of each type of filler material (saline vs gel) have already been discussed previously. When the breast reconstruction is performed as a delayed procedure, several reconstructive possibilities exist. Here, the local tissue quality is a very important factor to consider preoperatively. If the skin has been previously irradiated or if several local unfavourable conditions are present (adherent scar onto the thoracic wall, absent subcutaneous tissues and/or pectoralis muscle), the choice of introducing an expander alone is contraindicated, because of the very high extrusion rate. In this situation, to avoid potential implant exposition, healthy tissue should be added to cover the expander. This coverage is provided by a pedicled latissimus dorsi musculocutaneous flap (Fig. 6, 7). More recently, other techniques have been developed using only autologous tissue to avoid the afore mentioned disadvantages of breast implants. Autologous tissue taken from the abdomen or gluteal region is transferred as a free flap into the mastectomy site. In loco, a microsurgical anastomosis is then realized between the artery and vein of the flap and local recipient vessels (internal mammary or thoracodorsal vessels). These free perforator flaps include mainly the DIEP (deep Inferior epigastric perforator) and SGAP (superior gluteal artery perforator) flap and free TRAM flap (45-47) (Fig. 8, 9).

Breast Implants 163 Fig. 4 Preoperative view Fig. 5 Postoperative view of an aesthetic breast augmentation with subpectoral insertion of an anatomically shaped textured silicone-filled breast prosthesis. Fig. 6 Preoperative view of the mastectomy site on the left side Fig. 7 Postoperative view of a breast reconstruction with a pedicled latissimus dorsiflap and prosthesis with subsequent nipple-areola reconstruction and tattooing. Contralateral breast reduction and symmetrization. Fig. 8 Preoperative view of the mastectomy site at the right side Fig. 9 Postoperative view of a breast reconstruction by autologous tissue only by means of a DIEP flap and after subsequent nipple-areola reconstruction.

164 D. Van Zele and O. Heymans Today, this operation is also performed as an immediate procedure after mastectomy. Conclusion Breast implants have been used for about four decades for both reconstructive and aesthetic purposes. The use of silicone-gel implants in breast surgery dates back to 1963, when two doctors wrapped a thin envelope of rubbery silicone elastomer around a soft but firm siliconegel compound. Over the years, a variety of improvements have been made in both the gel compound and containing envelope, but today the basic implant design remains the same. Since the ban on silicone gel implants in the USA (in Belgium, on the contrary, silicone implants remained on the market and were never banned because lack of proved scientific evidence), research has been conducted to find a suitable substitute and implants with a silicone elastomer shell containing normal saline ( saltwater ) have been used as an alternative. However, saline breast implants are generally thought not to have as natural a feel or appearance as do silicone gel breast implants. Additionally, they have a high incidence rate of deflation. Furthermore, none of the other potential substitutes, such as soy or peanut oil-filled prostheses, have progressed beyond the experimental stage in the USA. Nothing man made has eternal life and implants are not an exception to this rule. Inherent in the process of implant aging is a range of complications based on scientific evidence, that should be discussed with the patient. Silicone gel breast implants may rupture and cause local symptoms, but they have not been demonstrated to be a systemic health hazard for patients who have undergone augmentation mammaplasty or postmastectomy reconstruction. In search of reducing furthermore the possibility of rupture and bleeding, the cohesive silicone gel implant was recently introduced on the market. 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