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From Wikipedia, the free encyclopedia

A breast implant is a prosthesis used in cosmetic surgery to enlarge the size of a woman's breasts (known as breast augmentation), or to reconstruct the breast (e.g., to correct genetic deformities or after a mastectomy, or during 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.^[1]

Contents 1 Types of implants 2 History 3 Silicone Gel Implants 3.1 First and Second Generation 3.2 Third Generation 3.3 Fourth Generation 4 Saline Implants 5 Techniques 6 Local Complications 7 Mammography 8 Risks and controversy 9 Rupture 9.1 Systemic Illness 9.1.1 Rheumatological 9.1.2 Oncological 9.1.3 Neurological 9.1.4 Additional Surgeries 10 Notes 11 References 12 See also 13 External links

Types of implants

There are three primary types of breast implant filler materials with many different shapes and textures:

• Saline, which have a silicone rubber shell filled with sterile saline liquid. These implants are currently the only type available outside of clinical trials in the United States, but future regulation may make more filler types available.
• Silicone gel, which have a silicone shell filled with a viscous silicone gel.
• String implant, which have a polypropylene material as an implant. String implants are unique in that they cause the breast to continue expanding after surgery, and were preferred by those women who choose to have the largest breasts possible, such as adult entertainers. String implants were eliminated years ago by the FDA due to the complications brought about by continuous growth after implantation.

History

Implants have been used at least since 1865 to augment the size of women's breasts. The earliest known implant occurred in Germany, in which fat from a lipoma (benign fatty lump) was removed from a woman's back and implanted in her breast. In the following years, the medical community experimented with implants of various materials, most commonly paraffin.

The first use of silicone for breast augmentation was immediately following World War II, when doctors in Japan and Las Vegas began injecting it to enlarge women's breasts. Initially they used the industrial kind of silicone that goes into making furniture polish and transformer fluid. Complications like cysts, sores and painful hardening of the breasts were in some cases so severe that women needed mastectomies. According to the New York Times, at least three women died when silicone obstructed their blood vessels and lungs.^[2] Women sometimes sought medical treatment up to 30 years after receiving this type of injection.

Silicone Gel Implants

Houston, Texas plastic surgeons Thomas Cronin and Frank Gerow developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961, and the first woman was implanted in 1962. The implant was made of a silicone rubber envelope (or sac), and was filled with a thick, viscous silicone gel.

When originally introduced by Cronin, medical devices were not regulated in the United States. After the law was changed in 1976 to give the Food and Drug Administration (FDA) the authority to regulate all medical devices, the FDA "grandfathered" many devices that were already on the market, including breast implants. As a result, the long-term safety of the devices had never been documented. In 1992, the FDA restricted the implantation of silicone gel-filled breast implants because of questions about their safety. Silicone implants may be used only under certain controlled conditions. The FDA has not yet lifted the ban for widespread use.^[3]

In Canada, silicone gel-filled prostheses were banned by Health Canada on 6th January 1992 in response to concerns raised in the scientific literature regarding possible illnesses associated with the implants. In 1999, Health Canada's Medical Devices Bureau began to make silicone implants available to plastic surgeons again under a Special Access Program. Under the program, surgeons must submit requests to use silicone implants to the Bureau on a case-by-case basis.^[4]

First and Second Generation

The first generation Cronin-Gerow implants were redesigned in the 1970's in response to surgeons asking for softer and more life-like devices. The original cohesive gel and thick-shell models were replaced in the 1970’s by implants with thinner gel and thinner shells. These "second generation" 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.

Another development in the 1970’s was a polyurethane foam coating on the implant shell. According to a Congressional report an estimated 200,000 women received this type of implant before it was discontinued in the early 1990's because of health concerns.^[5] Polyurethane coating was believed to diminish capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. The manufacturer later withdrew the product after FDA scientists determined that the foam broke down to TDA, a known animal carcinogen.^[6] Plastic surgeons have found that removing polyurethane-coated implants can be disfiguring and lead to chronic infection, drainage from the breast and skin ulceration.^[7] While still manufactured in Europe and South America, these implants are not FDA approved for sale in the United States.^[8]

Second-generation implants also included various “double lumen” designs. These implants had two cavities and two shells, which were either ”patched” together or had one shell floating freely inside the other. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside lumen, while the outside lumen contained saline and could be used for an expander and adjustability in volume after placement. The failure rate of these implants is higher than for single lumen implants. The contemporary versions of these devices ("Becker Implants") are used primarily for breast reconstruction.

Around 1985, gel implants were introduced that used thicker shells, a barrier-coat elastomer to decrease gel-bleed, and a more cohesive gel filler.

Third Generation

Third-generation implants, developed in the 1990s, are made of cohesive gel that better maintains its form. These implants are used in other countries, and are the implants currently being considered for FDA approval. However, these implants can rupture, and the rate of rupture of contemporary devices is still being determined. Data presented to the FDA from the core and adjunct studies is limited to 3 and 4 year data. The increased cohesion of the gel filler has decreased silicone bleed and is believed to reduce leakage of the gel as compared to earlier devices, although leakage of silicone oil has still been reported in these newer implants. FDA studies indicate that most women with these implants will have at least one ruptured implant within 11-15 years. Other studies estimate rupture rates of "at least 15%" of implants within the first 10 years.^[9]

Fourth Generation

Evaluation of "gummy bear" or high-cohesive, form-stable implants is in preliminary stages in the United States. Although these implants are used more widely in other countries, their long-term safety record is still being evaluated. It is speculated that the high degree of gel cohesion in these implants is likely to eliminate or significantly reduce potential silicone migration. Short-term safety reports have been favorable, but 10 to 20 year rupture and leakage data are needed to determine whether the silicone leakage problem has been solved.^[10][11][12]

Saline Implants

Early saline implants were reported in France and New York City in 1965. [1]. The early models frequently deflated. [2] In 1967, Dr. Henry Jenny, a California plastic surgeon, designed a saline implant that was sturdier than the earliest models and had a diaphragm valve, known as the "Jenny" valve. [3]. Dr. Jenny's concern was to provide a saline implant that would not deflate, and would be safer than the silicone implants. Dr. Jenny and Dr.Smahel of Switzerland followed up with a woman who had ruptured silicone implants, and found that silicone had gotten into not only her body tissues, but into the bloodstream and, as Dr. Jenny put it, "once in the blood, silicone would undoubtedly be distributed throughout the body." It was later proved that even implants that had not ruptured 'bled' silicone into many organs, including the spleen, liver and bone marrow. [4].

These early saline implants still had a high failure rate and were discontinued in the early 1970s. The current design has thicker, room temperature vulcanized (RTV) shells, but these still deflate over time. [5] After the FDA silicone gel moratorium in the early 1990's, saline implants became the dominant type placed in the United States. Saline implants lacked the problems of silicone fluid diffusion through the shell into the tissues; axillary adenopathy secondary to silicone; release of gel on implant rupture, higher incidences of contracture; and greater radiopacity of gel. [6]

Local complications for saline breast implants are similar to those for silicone gel implants. Case reports of bacteria and fungal contamination have been reported. Advantages of saline implants include intraoperative adjustability, decreased capsular contracture rates, and cost (several hundred dollars less per implant than silicone). As compared to silicone gel however, saline implants are more likely to cause rippling, wrinkling, and be noticeably palpable. Many surgeons also feel that they are more likely to cause a "bottoming out" appearance of the lower breast pole tissue from the weight of the saline. Some of these characteristics may be improved with newer designs, submuscular or partial submuscular placement and proper implant sizing. In patients with more breast tissue, it can be difficult to discern an advantage in feel or appearance to silicone. However, with thin breast tissue coverage, and particularly in the setting of post-mastectomy reconstruction, silicone implants offer a more natural appearance.

Techniques

There are several techniques employed in the insertion of breast implants. The choice of technique may depend on the surgeon's personal preferences as much as the patient's relevant anatomy, but there are certain considerations that the surgeon can use to help select the implant and method appropriate to the patient.^[13]

• Sub-Glandular - sub-glandular implants are placed in a pocket between the pectoralis major muscle posteriorly and the breast tissue and subcutaneous fat anteriorly. A surgeon may select this technique in a patient with a moderate amount of pre-existing breast tissue (e.g. if one is able to "pinch an inch" or more of skin and subcutaneous tissue 3-5 cm about the nipple).
  

Advantages -- the implant will not move with contraction of pec major, and thus is appropriate for physically active women; some believe it looks more natural; also a sub-glandular implant may create a better result (and lift) in a ptotic breast (where the nipple lies below the level of the infra-mammary fold).

Disadvantages -- unpleasant cosmetic effect in patients with very little covering tissue; the outline of the implant may be more visible, "rippling" may be apparent, capsular contractures (leading to hard, uneven breasts) may be more common.

• Sub-Fascial - in this technique the implant is placed into a pocket between the pectoralis major and its covering fascia.
• Sub-Muscular - here the implant is placed entirely or partially beneath the pectoralis major muscle, lying on the ribcage. A surgeon may select this technique in a patient with very little pre-existing breast tissue (e.g. one is unable to "pinch an inch").

Advantages -- mammograms may be more accurate than with subglandular implants, the implant may be less visible in very small-breasted women.

Disadvantages -- the implant may move noticeably with contraction of pec major, producing a very bizarre visual effect that will probably be considered undesirable by the patient. This effect may be especially noticeable in physically active females with well defined pectoral muscles.

There are also several choices for incision:

• Peri-Areolar - a semicircular incision around the lower half of the areola.
• Infra-Mammary - a transverse incision following the line of the infra-mammary fold.
• Axillary - an incision in the axilla (armpit) with a tunnel made through to the breast.

Local Complications

Local complications specific to breast implants include the following:[7][8][9][[10]

Rupture

Implants should not be expected to last a lifetime. When saline breast implants break, they often deflate quickly and can be easily removed. However, when silicone implants break they rarely deflate, and the silicone from the implant can leak and migrate outside of the scar tissue that the body creates around the implant. This is known as "extracapsular silicone", which can migrate to other parts of the body. Extracapsular silicone can cause granulomas and axillary adenopathy. Systemic risk and treatment of extracapsular silicone gel is still controversial. See Risks and controversy

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 and squeezes the implant. This contracture is a complication that can be painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, gel implant rupture or leakage, and hematoma. Correction of capsular contracture includes surgical removal of the implant capsule tissue or removal (and possible replacement) of the implant itself. Capsular contracture may happen again after this additional surgery.

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)

Hematoma/Seroma
Hematoma is a collection of blood inside a body cavity and a seroma is 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 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, (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, may prevent wound healing and require surgical correction and/or implant removal. A permanent scar may form.

Tissue Atrophy/Chest Wall Deformity
Pressure of the breast implant may cause the breast tissue to thin and shrink. This can occur while implants are still in place or following implant removal without replacement.

Mammography

Doctors still recommend that women with breast implants have mamograms. However, pressure on the breast (compression) during mammography can cause implant rupture. Breast implants also can interfere with finding breast cancer during mammography, because the implant shows up as a solid white shape, obscuring tumors above or below. In addition to making tumors more difficult to detect, implants cause "false positive" results as well when extensive scarring and calcium deposits mimic the appearance of cancer, making the deposits difficult to distinguish from tumors on a mammogram.^[14] Biopsy may be necessary to determine whether these are cancerous.

Specific mammogram techniques have been developed to ensure that as much breast tissue as possible is examined in the woman with implants. This requires taking extra images, called displacement views, which expose the woman to more radiation. In 2004, Miglioretti and her colleagues published a study in the Journal of the American Medical Association indicating that 55% of breast tumors were not initially detected on mammograms for women with implants, although the extra images were used.^[15]

This compares to about 30% of tumors that were not initially detected for women who did not have breast implants. These tumors were subsequently detected in later mammograms. Another problem is that calcium deposits can be seen on mammograms and can be mistaken for possible cancer, resulting in additional surgery to biopsy or remove the implant to distinguish these deposits from cancer. Calcium deposits may be felt as modules or bumps under the skin around the implant.

The displacement views do not protect against rupture, which becomes a greater problem as implants age. Dr. Lori Brown, an FDA scientist, published an article in 2004 in the Journal of Women's Health, indicating that the FDA has received dozens of reports of implants rupturing or leaking during mammography.^[16] Ultrasound and MRIs can be used to detect breast cancer instead of mammograms, but this adds to the cost of screening and may not be covered by health insurance.

Risks and controversy

Rupture

Implants should not be expected to last a lifetime. When saline breast implants break, they often deflate quickly and can more easily be removed. However, when silicone implants break they rarely deflate, and the silicone from the implant can leak and migrate outside of the scar tissue that the body creates around the implant. This is known as "extracapsular silicone."

The specific risk and treatment of extracapsular silicone gel is still controversial. In response to these concerns, FDA scientists completed a study on the health effects of ruptured silicone gel breast implants, which was published in the May 2001 Journal of Rheumatology.^[17] The authors reported a significant increase in fibromyalgia and connective tissue disease among women with extracapsular leakage, compared to women whose implants were not broken or whose rupture was intracapsular.

The FDA stated that rupture is a concern because:

1. Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues.
2. The relationship of free silicone to development or progression of disease is unknown.
3. Implant rupture is a device failure - the implant is no longer performing as intended.

A 2003 article by FDA scientists published in The Journal of Rheumatology stated that women with silicone breast implants report more severe pain and chronic fatigue.^[18] Notably, more women with ruptured implants than those with intact implants had debilitating chronic fatigue (75% vs 51%), postexertional malaise > 24 h (77% vs 51%), impaired short term memory (58% vs 38%), and multi-joint pain (77% vs 60%).

Pathology reports of ruptured implants often show giant cell formation indicating an immune response, as well as chronic inflammation. In a 2004 article in Journal of Autoimmunity, scientists reported patients with implants demonstrated statistically significant elevation in anti-silicone antibodies compared with the unimplanted control groups.^[19] The highest anti-silicone antibody levels were measured in implanted women with either frank implant ruptures or leakage of their silicone gel implants.

The age of the implant is an important factor in rupture. The FDA rupture study was superior to previous rupture studies because it was limited to women who had silicone gel implants for at least 6 years and had not removed their implants or reported problems with them. Based on magnetic resonance imaging (MRI) they found that 77% of the women had at least one ruptured implant, even though most had no symptoms and were unaware of the leakage.^[20]

Neither of the two US implant manufacturers have collected MRI data on rupture or leakage for women implants for more than 3-4 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, which included Mentor and Inamed implants as well as implants made by other companies.

Since the research indicates that most ruptures of silicone gel implants are "silent," with no symptoms, the FDA recommends MRIs as the gold standard for detecting rupture. The FDA General and Plastic Surgery Advisory Panel has considered recommending annual MRIs, but determined that the cost would be prohibitive for screening purposes. However, manufacturer data clearly indicate that clinical exams are inadequate to rule out suspected rupture.^[21]

Systemic Illness

Conflicting studies make the issue of systemic illness an ongoing concern for women considering breast implants. Thousands of women have reported that they became ill from their implants, particularly when silicone implants ruptured. Complaints include systemic fungus, neurological and rheumtological problems. Although that information is considered anecdotal, peer reviewed studies indicate that subjective and objective sympoms of many women with implants improve when their implants are removed. In a comparison study, there was a statistical correlation between local problems and systemic problems."^[22]

Rheumatological

A number of existing studies internationally, funded in part by manufacturers, has reported that there is no evidence of increased mortality or defined autoimmune diseases from silicone breast implants. However, the FDA points out that previous studies have not been 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. In addition, autoimmune diseases like lupus typically present with relatively subjective complaints such as joint pain, fatigue, muscle aches, and sleep disturbances. Since many of the symptoms characteristic of autoimmune diseases do not require surgery or inpatient care, it is unlikely that women will be hospitalized for them. The outcome measure for many of the previous European studies was women who were hospitalized for connective tissue diseases, and did not include women who were treated on an outpatient basis. Future study designs should consider these factors.

Studies reported by the FDA have shown that some women with silicone gel-filled breast implants produced antibodies to their own collagen. The researchers initially suspected that women with implants and symptoms actually had fibromyalgia. However, they found that 42 percent of symptomatic women with implants formed antibodies against their own B cells. Only 2 percent of healthy women formed autoantibodies, compared with 14 percent of asymptomatic women with implants and 19 percent of fibromyalgia patients. A recent report detailed HLA differences among women in whom inflammatory myopathy develops after they received silicone implants.^[23][24] We do not know as yet if these antibodies cause CTDs and related disorders.

In September of 2005, a Canadian Expert Advisory panel on Breast Implants echoed the FDA's concerns including recommending further outcome studies on device failure, rupture rates, and long term effects of silicone.^[25] The panel found that both companies provided appropriate information to show that silicones are not immunosuppressive materials. However, the panel did note that peer-reviewed literature raises questions about the potential of silicones and/or implant devices to induce autoimmune or hypersensitivity reactions. The Panel recommended to Health Canada that the manufacturers be required to demonstrate that migrated silicone provides acceptable risks of hypersensitivity and autoimmunity by a critical review of company and literature data and, if necessary, by undertaking studies in animal models.

Oncological

Scientists from the National Cancer Institute found an increased risk of lung cancer deaths in comparisons with other plastic surgery patients, although the women in the two groups had no difference in smoking habits. However, scientists did not find evidence that implant patients had a higher risk of death from breast cancer or brain cancer as compared with either the general population or other plastic surgery patients.^[26] They had previously reported preliminary data in 2001 indicating that women with breast implants for at least seven years were twice as likely to die of brain cancer and three times as likely to die of lung cancer. ^[27]

Neurological

In 2006, researchers reported in the Chemistry Analytic Journal that "women exposed to silicone breast implants have platinum levels that exceed that of the general population, and the first report, to date, to document the various platinium oxidation states present in samples from women exposed to silicone breast implants" that may be more toxic. The study found that platinum migrates from silicone implants via the lymphatic and blood systems and may accumulate in bone tissue persisting years after the silicone gel breast implants have been removed. Women with silicone breast implants had approximately 100 times higher platinum levels in their breast milk than women with no known platinum exposure. Platinum levels were as much as 1,700 times higher in urine.^[28]

The Washington Post quotes Lykissa, one of the researchers, saying "Implant manufacturers have said for years that their platinum is not harmful, and when the device is manufactured, they are correct, but in the body, we know that the implants degrade and the platinum can disperse and take on a more reactive form."^[29] The article also pointed out that the study was "quickly and aggressively attacked by other chemists, especially those with connections to breast implant makers." The study was funded in part by a nonprofit group that has argued to keep silicone implants off the market. The women in the study had their breast implants in the 1980s, and had had them for an average of 14 years. Many of these women had had them removed, generally because of health problems.

Additional Surgeries

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. Common reasons for reoperations include cosmetic concerns, capsular contracture, and rupture.^[14] Reoperation rates are less frequent in breast reconstruction cases. The major implant manufacturers, Mentor and Inamed, both reported that almost half their reconstruction patients underwent additional surgeries within three years to fix implant problems, whether their implants were silicone or saline. The exact statistics are available on the FDA website.

More than 50,000 implant removal procedures were also reported in 2004. In fact, the American Society of Plastic Surgeons reports that in 2000, about 26% of augmentation and 16% of reconstruction surgeries were for replacement of implants – due to capsular contracture, rupture, implant shift, chronic infection, or other causes.^[30]

Notes

References

See also

• body modification
• breast reconstruction
• breast reduction
• Micromastia

External links

• U.S. Food and Drug Administration
• Chronology of silicone breast implants
• E-medicine Summary of Silicone Implant Safety
• UK Independent Review Group on silicone Implants
• How Stuff Works: Breast Implants

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