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A breast implant is a prosthesis used to enlarge the size of a woman's breasts (known as breast augmentation) for cosmetic reasons, to reconstruct the breast (e.g. after a mastectomy or to correct genetic deformities), or as an aspect of male-to-female sex reassignment surgery. According to the American Society of Plastic Surgeons, breast augmentation is the third most commonly performed cosmetic surgical procedure in the United States. In 2005, 291,000 breast augmentation procedures were performed.

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.

History

Implants have been used since 1895 to augment the size or shape of women's breasts. The earliest known implant was attempted by Czerny, using a woman's own adipose tissue (from a lipoma, a benign growth, on her back). 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.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 patients 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. Development of silicone granulomas 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 are usually younger, healthier, and from higher socio-economic status than the population at large. Studies suggest that women who undergo breast implantation do not differ in self-esteem compared to other women, but are less satisfied with their breast size, and report a larger ideal breast size, with almost all choosing a cup size of C or D. This research indicates that desiring breast augmentation is not a function solely of small breast size but may also result from an ideal that is larger than that reported by the general population.

Benefits

A few post-operative surveys on mental health and quality of life issues have indicated improvement in physical health, physical appearance, social life and self confidence. However, these studies measure short-term outcomes and have other methodological shortcomings.

When the FDA compared scores on established self-esteem and quality of life measures before and two years after breast augmentation, they found either no improvement or a statistically significant decrease on most measures for Inamed patients and Mentor patients

In addition, five studies have found statistically significant doubling in suicides among women with breast augmenation compared with similar women in the general population or with other plastic surgery patients and a 2006 study conducted among 24,600 women by the Universite Laval Faculty of Medicine, the Canadian Public Health Agency and Cancer Care Ontario found that the suicide rate among women with breast implants is 73% higher than in the general population.

Types of implants

Saline Implants

Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion with the goal of being surgically placed via smaller incisions. These original devices had a high failure rate and were discontinued in the early 1970s . The 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).

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 implant generations

Silicone implants are generally described in terms of five generations which segregates common characteristics of manufacturing techniques.

• First generation

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. They were firm and had a "teardrop" anatomic shape.

• Second generation

Breast implants were redesigned in the 1970s with thinner gel and thinner shells, to make the implants softer and insertion easier. These implants had a greater tendency to rupture and leak, or "bleed" silicone through the porous shell, and complications such as capsular contracture were also quite common. It was predominantly implants of this generation that were involved in the class action-lawsuits against Dow-Corning in the early 1990s. Another development in the late 1970s and 1980s 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. The polyurethane was not medical grade, however, and the impants were difficult to surgically remove. They were later discontinued when the polyurethane was found to break down into TDA in the breast and breast milk; TDA is a known animal carcinogen. Polyurethane implants are still used in Europe and South America, but no manufacturer has sought FDA approval for sale in the United States. 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

Third & fourth generation implants, represented sequential advances in manufacturing principles and were elastomer-coated to decrease gel bleed, and a 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 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.

• Fifth generation

Evaluation of "gummy bear" or high-cohesive, form-stable implants is in preliminary stages in the United States but are widely used in the rest of the world. Implant manufacturers claim that the high degree of gel cohesion in these implants is likely to eliminate or significantly reduce the possibility of silicone migration. However, no long-term peer-reviewed studies are available to determine if these claims are accurate.

Silicone Implant Controversy

Although silicone gel-filled breast implants were introduced into the US market in the 1960s, the FDA did not have a statutory basis to regulate most medical devices until 1976. At that time, the U.S. FDA was required by law to examine the safety and effectiveness of all medical devices, including breast implants. Any devices which raised concerns among FDA scientists were classified as requiring evidence of safety and efficacy. In the early 1990's, the FDA notified implant manufacturers that studies would be required, and in 1992 the FDA concluded that the data submitted were not sufficient to prove safety.

As a result of the companies' failure to prove safety and obtain FDA approval, implants made from silicone gel were restricted in the U.S. in 1992. All women obtaining breast implants in the U.S. were required to participate in clinical trials, primarily for women needing reconstruction after mastectomy or breast deformity, or for women with implants that need to be replaced. Approximately one million women had implants at the time that these restrictions were instituted, and multi-million dollar jury awards and subsequent litigation led manufacturers to agree to a settlement of US$4.25 billion.

In November 2006, the FDA approved silicone implants from two manufacturers under several conditions. According to the FDA website, the approval is only for women ages 22 and older, and is contingent on each of the companies conducting 10-year studies of the complications and health risks of breast implants on at least 40,000 women.

In Canada, a similar series of events occurred where silicone gel-filled prostheses were restricted by Health Canada in 1992 prior to a limited reintroduction in 1999. In October 2006, Health Canada removed the restrictions on the use of these implants.

Complications

Local complications that can occur with breast implants include capsular contracture, rupture, 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.

The recent FDA approval of silicone implants stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one 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. The age and design of the implant are also important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult, because implant designs tend to change just as implants are old enough to study long-term. As a result, most studies include women with a range of implants, some of which are no longer sold.

Another shortcoming of previous studies is that most relied on clinical exams to determine rupture rates. Research indicates that clinical exams alone are inadequate to rule out suspected rupture. Since the research indicates that most ruptures of silicone gel implants are "silent," with no symptoms, the FDA has concluded that MRIs are necessary to most accurately identify rupture prior to surgery. Because of the risk of silent ruptures, the FDA recommends an MRI at three years after implantation and then every two years thereafter for screening purposes.

Neither of the two US implant manufacturers have collected MRI data on rupture or leakage for women implants for more than 3 years. Therefore, it is impossible to determine if the implants that those companies currently sell have a different rupture rate or likelihood of leakage compared to the implants in the FDA study cited above, which included Mentor and Inamed implants as well as implants made by other companies.

One of the only published studies with randomized MRI data on single lumen 3rd/4th generation silicone implants concluded that "the risk of implant rupture increases with implant age" and "a minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation." This study did not report the number of women with ruptured implants, but rather the percentage of implants that were ruptured. Since most women in the study who had a ruptured implant, had only one that was ruptured rather than two, the results indicate that at least 30% of women will experience at least one ruptured implant between the 3-10 years after augmentation.

A recent study funded by Inamed, similarly evaluated the percentage of implants that were ruptured, and was scientifically biased because it excluded women whose implants were removed within the first 10 years. It is therefore not surprising that the rupture prevalence in this small study was 8% at 11 years, involving approximately 16% of the women.

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 when recognized, both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate to the breast and the lymph nodes under the arm, resulting in granulomas (inflammatory nodules) and axillary lymphadenopathy (enlarged lymph glands in the armpit area). It is unknown how often that happens or what the health consequences will be if a ruptured implant remains in the body for several years. However, a 2001 study on silicone gel breast implants reported an increase in fibromyalgia among women with extracapsular leakage, compared to women whose implants were not broken or leaking outside the capsule.

Capsular contracture

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 or hardens around the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast.

There are four grades of capsular contracture:

• Grade I - breast normally soft and looks natural

• Grade II - breast little firm and looks normal

• Grade III - breast firm and looks abnormal (visible distortion)

• Grade IV - breast hard, painful and looks abnormal (greater distortion)

The exact cause of contracture is not known. However, several factors that increase capsular contracture include bacterial contamination, silicone rupture or leakage, and hematoma. Correction of capsular contracture usually requires surgical removal or release of the capsule and removal (and possible replacement) of the implant itself. Capsular contracture tends to recur if the implant is replaced.

Implant manufacturers warn against the use of closed capsulotomy, a once-common, painful procedure whereby the capsule is broken by squeezing, because it can cause implants to rupture.

There is some evidence that submuscular implant placement, using textured implants can reduce capsular contracture

Hematoma and seroma

Two known complications of breastimplants include hematoma, the collection of blood inside a body cavity, and seroma, a collection of the watery portion of the blood around the implant or around healing.

A small scar can form or a rupture may occur if the implant is damaged during draining the incision. Post-operative hematoma and seroma may contribute to infection or capsular contracture.

Changes in nipple and breast sensation

Feeling in the nipple and breast can change after implant surgery.

Changes vary from intense sensitivity to no feeling in the nipple or breast after surgery. This altered sensation can be temporary or permanent and may affect sexual response or the ability to nurse a baby.

Extrusion

Unstable or weakened tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin.

Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.

Necrosis

Necrosis, the death of tissue around the implant, requires surgery and may necessitate implant removal.

According to studies by Inamed, necrosis occurs more frequently for silicone gel breast implants than saline implants and more frequently for reconstruction patients than augmentation patients. A permanent scar may form.

Diseases and Systemic Illness

Thousands of women have claimed that they became ill from their implants, particularly when silicone implants ruptured. Complaints include neurological and rheumatological problems. Although information from individual reports is considered anecdotal regardless of the numbers involved, peer-reviewed studies indicate that subjective and objective symptoms of many women with implants improve when their implants are removed. For example, in a comparison study, rheumatologists reported that women with rheumatological symptoms who had their implants removed and not replaced experienced limprovement in their health, and women whose implants were not removed or removed and replaced did not. More research is needed to determine how often implant removal results in a reduction in rheumatological symptoms.

Numerous reports have reported that there is no evidence of increased mortality or classically defined autoimmune diseases among women with silicone breast implants. These include the Canadian Expert Advisory Committee review in 1992, ANDEM in France in 1996, the UK Independent Review Group 1998, and the U.S. Institute of Medicine in 1999, and the Scientific Technical Opinions Assessment (STOA) report commissioned by the European Parliament in 2001 (updated in 2003). Although these reports were independently conducted and funded, they did not conduct new studies and were instead based on the published research available at the time, most of which were funded by Dow Corning at a time that the company was being sued by women claiming illness from their breast implants.

Many of these reports are based on studies with small sample sizes that included women who had implants for just a few months or years. Years later, in 2004, the FDA pointed out that previous studies were not large enough to answer the question of whether or not breast implants increase the risk of connective tissue disease or related disorders. Several autoimmune conditions, such as scleroderma and Sjogren's, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. 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. The FDA states: "When considered together, these studies indicate that the risk of developing a typical or defined CTD or related disorder due to having a breast implant is low. However, these studies have not been large enough to resolve the question of whether or not breast implants slightly increase the risk of CTDs or related disorders. 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."

There is no conclusive evidence linking breast implants to disease diagnosis, but as studies have followed women with implants for a longer period of time, evidence has grown regarding symptoms that are typical of autoimmune diseases. A Danish study, funded by Dow Corning and the Danish Cancer Society, reported that women who had breast implants for an average of 19 years were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), and memory loss and other cognitive symptoms, compared to women of the same age in the general population. Despite reporting that women with implants were between two and three times as likely to report those symptoms, the researchers concluded that long-term exposure to breast implants "does not appear to be associated with autoimmune symptoms or diseases."

Meanwhile, research on symptoms suggests that even in the short-term, women with silicone implants report more autoimmune symptoms. In data presented to the FDA, Inamed and Mentor both found that women with implants for only two years had a significant increase in auto-immune symptoms such as joint pain and nervous system symptoms. The findings remained significant when the women's age was statistically controlled.

Despite these concerns, it is generally acknowledged that women undergoing breast augmentation or other plastic surgery tend to be healthier than the general population. In a study of several thousand plastic surgery patients, scientists from the National Cancer Institute found that augmented women were healthier than the general population, and yet were twice as likely to die from lung cancer or brain cancer, compared with other plastic surgery patients. There were no reported differences in smoking habits that would explain the difference in lung cancer deaths; the authors suggested that more research was needed to determine if implants increase the risk of lung cancer or if undocumented differences in smoking were a contributing factor.

There is no evidence from the National Cancer Institute study or other studies that implant patients have a higher risk of death from breast cancer as compared with either the general population or other plastic surgery patients.

Another large study of nearly 25,000 Canadian women with implants reported lower cancer rates among augmentation patients, which the authors attributed to their higher income and better health prior to surgery.

Platinum

Platinum is a catalyst used in the making of silicone implant polymer shells and other silicone devices used in medicine. The literature indicates that small amounts of platinum leaches (leaks) from these implants and is present in the surrounding tissue. The FDA reviewed the available studies from the medical literature on platinum and breast implants in 2002 and concluded there was little evidence suggesting toxicity from platinum in implant patients.

In 2006, researchers published a controversial study that reported the presence of toxic platinum salts in the blood, urine, and breast milk of women with silicone gel breast implants, but not in women with saline implants. . Despite the lack of any other peer-reviewed research on the platinum in women's bodies or breast milk, the FDA has stated that the platinum in silicone implants is likely not ionized and therefore would not represent a significant risk to women.

Breast Cancer Screening and Treatment Problems for Implant Patients

Breast implants are radio-opaque, showing up as white solid shapes on mammograms and interfering with their accuracy. Specialized radiographic techniques, using extra views where the implant is manually displaced ("Eklund views") may improve this somewhat, but studies show that these are still less accurate than mammograms for women without implants. For example, one study found that 55% of cancerous tumors were undetected because of implants. Another study similarly found that one-third of the breast is not adequately visualized even with Eklund displacement views, resulting in an increase in false-negative mammograms.

Nevertheless, several studies of breast cancers in women with implants have found a similar prognosis for augmented patients compared to women without implants or after reconstruction for mastectomy.

Although implants for augmentation do not eliminate the opportunity for breast conservation (lumpectomy) surgery for a woman who subsequently developes breast cancer, it decreases the chances of a successful outcome. Women with augmented breasts are less likely to undergo lumpectomy than other women, and radiation for women with implants commonly causes fibrosis of breast tissue and an increase in capsular contracture.

Revision surgery

Regardless of the type of implant, it is likely that women with implants will need to have one or more additional surgeries (reoperations) over the course of their lives. The most common reasons for reoperations are capsular contracture and suspected rupture, both of which occur frequently within 10 years. Reoperation rates are more frequent in breast reconstruction cases. A study funded by Dow Corning reported a 21% re-operation rate for reconstruction patients with implants for an average of 23 months. The re-operation rate was twice as high in an FDA analysis of reconstruction patients studied by Inamed. <[>

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External links

• U.S. Food and Drug Administration (FDA) - breast implant page
• U.K. Medicines & Health Care Products Regulatory Agency (MHRA) - breast implant page
• Basics of implant based breast reconstruction (E-medicine)
• How Stuff Works: Breast Implants

Silicone Breast Implants

• * Harvard Law School LEDA project:The Silicone Gel-Filled Breast Implant Controversy: Testing the Bounds of Regulatory Intervention
• Institute of Medicine (IOM) Report on Silicone Implants
• European Committee on Quality Assurance and Medical Devices in Plastic Surgery (EQUAM) consenus declaration
• Summary of Silicone Implant Safety (E-medicine)
• Breast Implant Safety (National Research Center for Women and Families)
• Science On Trial- Medical Evidence and the Law in the Breast Implant Case by Dr. Marcia Angell

• Breast
• Implants
• Plastic surgery