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There are two primary types of breast implants: saline-filled and silicone-gel-filled implants. ''Saline implants'' have a Silicone elastomer shell filled with sterile Saline liquid. ''Silicone gel implants'' have a silicone shell filled with a viscous Silicone gel. There have been several alternative types of breast implants developed, such as Polypropylene String or soy oil, but these are uncommon. HISTORY Implants have been used since 1895 to augment the size or shape of women's Breast s. The earliest known implant was attempted by Czerny , using a woman's own Adipose Tissue (from a Lipoma , a benign growth, on her back).1 Gersuny tried Paraffin injections in 1889, with disastrous results. Subsequently, in the early to mid-1900s, a number of other substances were tried, including Ivory , glass balls, ground rubber, ox cartilage, Terylene wool, Gutta-percha , Dicora, Polyethylene chips, Polyvinyl Alcohol -formaldehyde polymer sponge (Ivalon), Ivalon in a polyethylene sac, polyether foam sponge (Etheron), polyethylene tape (Polystan) or strips wound into a ball, polyester (polyurethane foam sponge) Silastic rubber, and teflon-silicone prostheses.2 In recent history, various creams and medicaments have been used in attempts to increase bust size, and Berson in 1945 and Maliniac in 1950 performed a flap-based augmentation by rotating the patient's chest wall tissue into the breast to add volume. Various synthetics were used throughout the 1950s and 1960s, including silicone injections, which an estimated 50,000 women received.3 Development of silicone Granuloma s and hardening of the breasts were in some cases so severe that women needed to have Mastectomies for treatment. Women sometimes seek medical treatment for complications up to 30 years after receiving this type of injection. INDICATIONS Clinical indications for the use of breast implants are for Breast Reconstruction , Sex Reassignment Surgery , and for abnormalities that affect the shape and size of the breast. In some countries Health Insurers will reimburse insertion of breast implants only for these indications. Non-clinical indications (the most common reasons) are cosmetic. PATIENT CHARACTERISTICS Patients seeking breast augmentation have been reported as being usually younger, healthier, from higher socio-economic status, and more often married with children than the population at large.4 Many of these patients have reported greater distress about their appearance in a variety of situations, and have endured teasing about their appearance. Studies have identified a pattern (shared by many cosmetic surgery procedures) that suggest women who undergo breast implantation are slightly more likely to have undergone psychotherapy, have low levels of self-esteem, and have higher prevalences of Depression , Suicide attempts, and mental illness (including Body Dysmorphia 5) as compared to the general population.6 PROCEDURE The surgical procedure for breast augmentation takes approximately one to two hours.12 Variations in the procedure include the incision type, implant material, and implant pocket placement. Incision types Breast implants for augmentation may be placed via various types of incisions:
Types of implants Saline implants Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion15 with the goal of being surgically placed via smaller incisions. Current devices are manufactured with thicker, room temperature vulcanized (RTV) shells. These shells are made of silicone elastomer and the implants are filled with salt water after the implant is placed in the body. Since the implants are empty when they are surgically inserted, the scar is smaller than is necessary for silicone gel breast implants (which are filled with silicone before the surgery is performed). A single manufacturer (Poly Implant Prosthesis, France) produced a model of pre-filled saline implants which has been reported to have high failure rates in vivo.16 Saline-filled implants are the most common implant used in the United States due to restrictions on silicone implants, but are rarely used in other countries. Good to excellent results may be obtained, but as compared to silicone gel implants, saline implants are more likely to cause cosmetic problems such as rippling, wrinkling, and be noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy reconstruction, plastic surgeons believe that silicone gel implants are the superior device. In patients with more breast tissue, however, saline implants can look very similar to silicone gel. Silicone gel implants Thomas Cronin and Frank Gerow , two Houston , Texas , Plastic Surgeons , developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961 . The first woman was implanted in 1962 . Silicone implants are generally described in terms of five generations which segregate common characteristics of manufacturing techniques.
The Cronin-Gerow implants were made of a silicone rubber envelope (or sac), filled with a thick, viscous silicone gel with a Dacron patch on the posterior shell.17 They were firm and had an anatomic "teardrop" shape.
In response to surgeons' requests for softer and more lifelike implants, breast implants were redesigned in the 1970s with thinner gel and thinner shells. These implants had a greater tendency to rupture and leak, or "bleed" silicone through the implant shell, and complications such as Capsular Contracture were quite common. It was predominantly implants of this generation that were involved in the class action-lawsuits against Dow-Corning and other manufacturers in the early 1990s. Another development in the 1970s was a ''polyurethane foam coating'' on the implant shell which was effective in diminishing capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. These implants were later briefly discontinued due to concern of potential carcinogenic breakdown products from the polyurethane.18 A review of the risk for cancer from TDA by the FDA later concluded that the risk was so small so as not to justify recommending explantation of the devices from individual patients. Polyurethane implants are still used in Europe and South America, but no manufacturer has sought FDA approval for sale in the United States.19 Second-generation implants also included various "double lumen" designs. These implants were essentially a silicone implant inside a saline implant. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside lumen, while the outside lumen contained saline and its volume could be adjusted after placement. The failure rate of these implants is higher than for single lumen implants due to their more complex design. The contemporary versions of these devices ("Becker Implants") are used primarily for breast reconstruction.
Third & fourth generation implants, from the mid 1980s, represented sequential advances in manufacturing principles with elastomer-coated shells to decrease gel bleed, and are filled with thicker, more cohesive gel. These implants are sold under restricted conditions in the U.S. and Canada, and are widely used in other countries. The increased cohesion of the gel filler reduces potential leakage of the gel compared to earlier devices. A variety of both round and tapered anatomic shapes are available. Anatomic shaped implants are uniformly textured to reduce rotation, while round devices are available in smooth or textured surfaces.
Evaluation of " Gummy Bear " or solid, high-cohesive, form-stable implants is in preliminary stages in the United States but these implants have been used since the mid 1990s in other countries. The semi-solid gel in these type of implants significantly reduces the possibility of silicone migration. Studies of these devices have shown significant potential improvements in safety and efficacy over the older implants with low rates of capsular contracture and rupture. 202122 Implant pocket placement The placement of implants is described in relation to the Pectoralis Major Muscle .
RECOVERY Depending on the level of activity required, patients are generally able to return to work or school in approximately one week's time. Scars from a breast augmentation surgery will last six weeks or longer and usually begin to fade several months after surgery. CLAIMS OF SYSTEMIC ILLNESS AND DISEASE Since the early 1990s, a number of independent systemic comprehensive reviews have examined studies concerning links between silicone gel breast implants and systemic diseases. The consensus of these reviews is that there is no clear evidence of a causal link between the implantation of silicone breast implants and systemic disease.26272829 Thousands of women claim that they have become ill from their implants. Complaints include Neurological and Rheumatological problems. Some studies have suggested that subjective and objective symptoms of women with implants may improve when their implants are removed. 30 As studies have followed women with implants for a longer period of time, more data has become available on systemic diseases as well as autoimmune symptoms. Several large studies from the national health registry in Denmark found implant recipients no more likely to be diagnosed with an increased incidence of classic auto-immune symptoms as compared to women of the same age in the general population,31 and that musculoskeletal symptoms were generally lower among women with implants compared with women with other cosmetic surgery and women in the general population.32 Recent longitudinal follow-up of these patients has confirmed previously reported findings. 33 Several studies have established that women who elect to undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. For example, two large studies of plastic surgery patients found a decreased Standardized Mortality Ratio in both breast implant and other plastic surgery patients, but an increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery. Smoking was statistically controlled in one study and not in the other, but the authors speculated that there could potentially be differences in smoking that might contribute to the higher lung cancer deaths among women with implants.3435 Another large study with long-term follow-up of nearly 25,000 Canadian women with implants reported, "Findings suggest that breast implants do not directly increase mortality in women."36 In 2001 a study suggested an increase in Fibromyalgia among women with extracapsular silicone gel leakage, compared to women whose implants were not broken or leaking outside the capsule.37 This association has not repeated in a number of related studies,38 and the US-FDA concluded "the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants."39 While there is a general international consensus that silicone implants have not been shown to cause systemic illness, excluding the possibility that a small group of patients may become ill through (as yet) unknown mechanisms may prove difficult. As the US-FDA notes "researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made." COMPLICATIONS Local complications that can occur with breast implants include post-operative bleeding ( Hematoma ), fluid collections ( Seroma ), surgical site infection, breast pain, alterations in nipple sensation, interference with breast feeding, visible wrinkling, asymmetric appearance, wound dehiscence (with potential implant exposure), thinning of the breast tissue, and synmastia (disruption of the natural plane between breasts). Rupture Breast implants do not last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants approved by FDA in May 2000 showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients. Manufacturers are required to inform women that the implants are not necessarily permanent devices and that most recipients will likely need additional surgery to replace or remove their implants. Rupture is one reason for reoperation. Among the causes of rupture are damage during implantation or other procedures, trauma to the chest, and the pressure of mammograms.40 The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult for a variety of reasons, particularly because implant designs have changed over time. Many older studies relied on clinical exams to determine implant rupture rates, while more recent reports indicate that clinical exams alone are inadequate to evaluate suspected rupture. An often cited study reported that only 30% of ruptures in asymptomatic patients are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs 41 The FDA has recommended that MRIs be considered to screen for silent rupture starting at three years after implantation and then every two years thereafter.42 Other countries have not endorsed routine MRI screening, and have taken the position that MRI should be reserved only for cases involving suspected clinical rupture or to confirm mammographic or ultrasound studies suggesting rupture. In the first study using MRIs for women with silicone gel breast implants, the FDA found that after 11 years, most women had at least one ruptured implant, and the silicone was leaking outside of the capsule of 21% of the women in the study. 43 However that study included women whose implants dated from before 1990, and many of the implants were 2nd generation. MRI data from the US-FDA required "core" studies of contemporary implants has demonstrated low rupture rates. The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and has reported silent rupture rates of at between 8% to 15% at or around a decade. 44 45 46 This represented a 15-30% silent rupture risk for individual patients. The first series of MRI evaluation of the highly-cohesive (5th generation) gel implants suggests improved durability, with a rupture rate reported at 1% or less, at a median age of six years. 47 When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the intracapsular space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate, but most clinical complications have appeared to be limited to the breast and axillae 48 in the form of Granulomas (inflammatory nodules) and Axilla ry Lymphadenopathy 49(enlarged lymph glands in the armpit area).50 The specific risk and treatment of extracapsular silicone gel is still controversial. Plastic surgeons agree that it is difficult to remove, but there is disagreement about the health effects. Capsular contracture See main article, Capsules of tightly-woven collagen fibers form as an Immune Response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular Contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and Hematoma . Capsular contracture may happen again after this additional surgery. Methods which have reduced capsular contracture include submuscular implant placement, using textured5152 or polyurethane-coated implants,53 limiting handling of the implants and skin contact prior to insertion54 and irrigation with triple-antibiotic solutions.55 Correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), a once common maneuver for treating hard capsules, has been discouraged as it can cause implant rupture. Nonsurgical methods of treating capsules include massage, external ultrasound,56 treatment with Leukotriene pathway inhibitors (Accolate, Singulair),57 58and pulsed electromagnetic field therapy.59
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